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+cik,ticker,company_name,year,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url
+0001816708,OWLTW,"Owlet, Inc.",2024,10-K,2025-03-11,2024-12-31,2025-03-11T20:46:25.000Z,0001628280-25-012035,owlt-20241231.htm,10-K,12732043,1,1,https://www.sec.gov/Archives/edgar/data/1816708/000162828025012035/owlt-20241231.htm,https://www.sec.gov/Archives/edgar/data/1816708/000162828025012035/

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+Item 1. Business 
+We are Owlet 
+Globally, over 140 million new lives are brought into the world every year. Yet, the infancy period remains fraught with complexities. In the United States alone, a family will lose over 44 nights of sleep in the first year, and families of young children will see, annually, nearly 13 million sick visits and 3.4 million emergency room visits, and tragically, more than 3,700 infants are lost unexpectedly in their homes every year. We believe the majority of these challenges unfold within the security of the home. 
+The persistence of unexpected infant fatalities remains unchanged for over a quarter-century, compounded by a recent increase in Respiratory Syncytial Virus (RSV) and pneumonia among children. The staggering number of healthcare visits underscores what we believe is a dire need for change, starting with the home. 
+Our belief is steadfast. We believe that parenting should come with empowerment, the kind that's informed, data-driven, and supported every step of the way. Owlet stands as a beacon for this empowerment, aimed to equip families with the tools intended for their little ones' safety, health, and joy. 
+Our vision is ambitious yet clear. We want to forge a world where every infant, regardless of socioeconomic background, benefits from health monitoring technologies akin to Owlet's. Our mission is to arm parents with crucial information when they need it most, aiming to safeguard children's health, optimize their well-being, and help facilitate peaceful sleep. We're committed to improving overall health outcomes. 
+Our values underscore our mission. We advocate for parental leadership in healthcare, backed by technological advancements. We prioritize our collective mission above individual egos, innovate to address genuine needs, and foster a culture of teamwork and mutual support. Our products are intended to empower parents with the right information at the right time. 
+We believe our ecosystem of digital parenting solutions can help transform modern parenting. We are providing parents data-driven insights into their children’s well-being in the comfort of their own home. Our digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident and well rested. We also believe that every child deserves to live a long, happy, and healthy life, and we are working to develop products to help further that belief. 
+Products and Services 
+Our devices are intended to empower parents with the right information at the right time. Owlet’s Dream Sock received a de novo device classification from United States Food and Drug Administration ("FDA") to market as a medical device a first-of-its kind, over-the-counter device for the in-home environment that provides a notification to the caregiver when an infant’s pulse rate and/or oxygen saturation moves outside of preset ranges (“Health Notifications”), displays the infant’s live pulse rate and oxygen saturation values and trends (“Live Health Readings”), and is intended for use in infants who are 1 to 18 months of age and between 6 and 30 pounds and have not been previously diagnosed with a cardiovascular or respiratory disease or condition. The notifications and associated data are intended to be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant, but not to replace traditional methods of monitoring, diagnosis or treatment. 
+• Sock Monitor Offerings 
+• Dream Sock – An award-winning, wearable, smart infant health monitor equipped with pulse oximetry technology that tracks vital signs such as pulse rate, oxygen level, activity, and sleep patterns. Dream Sock aims to provide more peace of mind for parents by providing real-time notifications to caregivers when a baby’s pulse rate and/or oxygen saturation fall outside preset ranges, all while offering tailored sleep insights in the Owlet Dream App. Dream Sock with Live Health Readings and Health Notifications has an FDA marketing authorization in the U.S., and is CE marked, as defined below, under EU Medical Devices Regulation in the European Union and UKCA marked in the United Kingdom. A version of Dream Sock without Live Health Readings and Health Notifications is offered in Canada and tracks Sleep Quality Indicators, including heart rate, 10-minute historic average oxygen level, and more. 
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+• BabySat – Designed for infants that could benefit from additional monitoring at home under the supervision of a physician, BabySat provides caregivers a prescription version of our wearable infant monitor that offers customizable alarm limits via the Owlet Care+ App. This device is best suited for babies with conditions such as RSV, pneumonia, bronchitis, croup, or other diagnoses. With BabySat, supported by insurance reimbursement, parents with coverage can secure vital monitoring at low or no cost. BabySat is FDA-cleared and offered in the U.S. only. The BabySat pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment. 
+• Owlet Smart Sock – Smart Sock is Owlet’s first smart baby monitor to track an infant’s oxygen saturation, heart rate, and sleep trends. Owlet Smart Sock allows parents to view their baby’s heart rate and oxygen readings in real-time from the Owlet Care App. If the baby’s readings leave preset zones, parents are notified through the Owlet Care App and a nearby base station. Owlet Smart Sock is sold in Australia, New Zealand, South Africa and certain other markets around the world. Owlet Smart Sock was also sold in the United States, the United Kingdom and the European Union prior to the launch of Dream Sock. 
+• Owlet Cam – This smart audio and video monitor allows caregivers to monitor their babies at anytime from anywhere, offering 1080p HD video, motion and cry detection, 4x zoom, and two-way audio, so parents can remain connected, regardless of distance. 
+• Dream Duo – Combining Dream Sock or Owlet Smart Sock with Owlet Cam, this baby monitoring solution offers HD video, sleep insights, and health tracking to offer an extensive view into an infant's well-being. 
+• Owlet360 – Owlet’s innovative subscription service leverages the Company’s infant health and sleep data to provide parents and caregivers with a deeper, personalized understanding of their babies’ development, health, and sleep trends. Owlet360 aims to empower parents with actionable information to support babies' well-being and parents’ peace of mind. Owlet360 is available for all new and existing Owlet Dream App users in the U.S. only. 
+• Accessories – Enhancing the Owlet experience, offered accessories include fabric accessory socks in various colors and patterns, the Owlet Dream Sleeper with Swaddle and the Owlet Sock Travel Case. 
+Our Platform and Pipeline 
+Since our inception, over 2 million Owlet devices have been sold worldwide, which has contributed to one of the largest data sets of infant health and sleep. We believe that data will be an invaluable tool in bridging the current healthcare gap between hospital and home. We will continue to develop our software and data in order to bring additional solutions into the home. Through leveraging our data, we believe we can help bridge the gap and better democratize access to individualized care. 
+We are building our data platform with the goal to be parents’ go-to brand in the areas of sleep, safety, health and well-being information. We will remain focused on commercializing our Dream Sock and BabySat devices, which we believe will open the door to launch additional services to continue the expansion of our data platform. We believe that we can use our data sets to enhance our product with additional valuable data insights as part of new subscription models and increasingly predictive technologies. 
+We believe we have developed deep and enduring relationships with our users and brand advocates around the world. We believe these parents are more likely to be early technology adopters and have a high affinity towards actionable insight to care for their children. This is evidenced by the millions of downloads of the Owlet applications and high social media engagement across our multiple platforms. These relationships continue to grow and develop in tandem with our novel product and software additions to our connected ecosystem, feature enhancements, omni-channel distribution, and marketing efforts. As we bring this valued relationship with consumer users into new medical communities, we believe that our platforms will continue to evolve and expand. 
+Strategic Business Segments 
+Owlet products are marketed and distributed in the United States and internationally through consumer and, more recently, through medical distribution channels. 
+Direct to Consumer & Digital Engagement: The Owlet brand resonates deeply with over 1 million social media followers, hundreds of millions of views and engagements and millions of website visitors each year. Our focus on 
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+engaging directly with our customer is driving significant sales through direct channels and increases demand through our retail partnerships. Our digital presence is a cornerstone of our strategy, enhancing customer lifetime value and fostering brand loyalty. 
+Retail Partnerships: Our products are widely available across major U.S. retailers, including Amazon, Target, Walmart, Best Buy and BabyList. 
+Global Reach & Distribution: Our international strategy is taking root and continuing to grow, with distribution partners in key global markets including Canada, Australia, the United Kingdom and throughout the rest of the European Union. We intend to continue expanding our global footprint and accessibility, underscoring our commitment to global health and well-being. 
+Healthcare Distribution & Insurance Reimbursement: The FDA clearance and subsequent launch of BabySat marks a significant opportunity to expand into healthcare distribution, opening potential new channels for insurance reimbursement and professional recommendations. We believe that this development not only broadens access, but also cements Owlet's role in the healthcare ecosystem. Our partnership with AdaptHealth and other Durable Medical Equipment suppliers (“DMEs”) may facilitate access to insurance reimbursement and distribution through hospitals. Owlet is focused on enlisting a wide variety of healthcare partners to increase the accessibility and affordability of our products while increasing our margin. 
+Our Strategy 
+2024 - Pivotal Year 
+In 2024, we introduced FDA-cleared devices Dream Sock and BabySat to deliver improved comfort to parents wishing for better safety and monitoring for their children. We believe that the FDA marketing authorizations for both Dream Sock and BabySat mark a significant moment for the pediatric category and solidify the trust of consumers and healthcare professionals alike. Our de novo classification of Dream Sock as an over-the-counter device was the first of its kind, and Dream Sock is currently the only monitor on the market in our product category authorized by the FDA. We believe that this achievement is a testament to our unwavering dedication to enhancing accessibility and reinforcing confidence in our innovative solutions. 
+We launched Dream Sock in the European Union and the United Kingdom after having received certifications in May 2024 and June 2024, respectively. We leveraged these endorsements of our technologies to expand our global footprint throughout 2024, taking us to 26 total countries by year end, contributing to 98% international revenue growth in 2024 versus 2023. 
+Finally, we crossed an important milestone with the development and deployment of our Owlet360 subscription service. We released a beta version of the subscription, scaling to a limited number of users throughout 2024, which set the stage to unlock the potential of our massive pediatric health and sleep data set. This culminated in our recent full launch of Owlet360 in January 2025. The introduction of Owlet360 marks a significant step in Owlet's evolution into a comprehensive pediatric health platform. 
+Alongside our 2024 product, sales, and partnership successes, we significantly improved financial performance. We improved our net loss by $20.4 million in 2024 compared to 2023. We also set company records for revenue, gross profit, gross margin, and adjusted EBITDA for full year 2024. We improved adjusted EBITDA profitability by $14.3 million in 2024 compared to 2023, including reaching positive adjusted EBITDA in the final three quarters of 2024. Adjusted EBITDA is a non-GAAP metric. For additional information on Adjusted EBITDA and a reconciliation to the most directly comparable GAAP equivalent, see Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations — Non-GAAP Financial Measures.” 
+We are committed to building a strong foundation for sustainable growth as we move forward and we believe that the FDA marketing authorizations of our BabySat and Dream Sock products will accelerate the adoption of our products and position us as the preferred pediatric data monitoring platform that bridges the gap between the hospital and the home. Throughout this journey, the Owlet team embodied our foundational values, undertaking substantial efforts to refine and advance our operations, setting the stage for growth and prosperity in 2025. 
+Strategy Overview 
+Driving Growth: Our vision is clear - we see health sensing technology becoming as ubiquitous as car seats and breast pumps for newborns. With the momentum we have gained from FDA marketing authorizations, the introduction of potential insurance coverage and reimbursement for BabySat, the launch of Owlet360 subscription 
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+service, increased credibility in medical communities, and an increased retail presence, we see Owlet as strategically positioned for substantial growth. Combining both the 510(k) clearance and de novo FDA authorization for our pulse-oximetry medical devices, and accompanying digital health offerings with our existing consumer brand well-known with over 2 million devices sold, we believe that we can become one of the most recognizable brand names in the digital parenting category. We believe expanding our recognizable brand into new channels will help our offerings stand out in a highly fragmented market. We see potential to grow our existing product suite with medical market penetration. We see opportunity to leverage the value from our massive data set of pediatric health and sleep information as an additional growth driver through the launch of our new subscription service, Owlet360. 
+Achieving Profitability: In 2024, our objective was to significantly improve adjusted EBITDA and narrow the gap to achieving breakeven. Through volume growth, gross margin expansion, and diligent management of operating expenses, we achieved positive adjusted EBITDA in the final three quarters of 2024 and made significant progress towards meeting this target. These accomplishments have furnished Owlet with operational leverage and we believe have the potential to drive profitability and cash flow in the future. 
+Expanding Lifetime Value (LTV): We view Owlet's brand as synonymous with engagement and loyalty in our industry, supported by a rich dataset that underpins our market understanding. With the introduction of our new subscription service, Owlet360, we believe we are well-positioned to forge deeper connections among parents, their infants, and healthcare providers. Owlet360 aims to elevate home care to new standards, augmenting the value we believe Owlet delivers to families and increasing the lifetime value per customer. Our strategy is not just about growth; it is about enriching the ecosystem of infant care with Owlet at its heart, fostering a healthier future for the next generation. 
+Market Landscape and Competitive Dynamics 
+Owlet has a clear and specific market in pediatrics serving the needs of parents with children aged 1-18 months across key markets in the U.S., Europe, Australia, and Canada. With close to 10 million infants born annually in these regions, our Total Addressable Market (“TAM”) is continuously replenished, providing the potential for a steady demand for our products. Despite a slight decline in birth rates, the emphasis on infant care and the financial investment in the well-being of newborns have seen a consistent uptick over the years. This trend underscores a growing market resilience, notably within the baby care sector, which has remained robust against broader economic fluctuations affecting consumer spending. 
+Since its inception, Owlet has been at the forefront of the consumer digital health monitoring space for infants and their families. We believe that our pioneering achievement of obtaining the first de novo authorization for at-home monitoring without the need for a prescription underscores our trailblazing efforts and helps set a high regulatory bar for new entrants in the space. This distinction is critical as it denotes that any comparable product with medical applications will likely require similar regulatory endorsements. 
+In addition to spearheading the health monitoring category, Owlet competes within the broader realm of general video/audio baby monitors. Our strategic edge is encapsulated in the Dream Sock and Owlet Cam combo, providing parents with a holistic view of their baby's health and well-being. This integration allows parents to see, hear, and be assured of their baby's condition through our app, offering an unmatched value proposition. 
+We believe that we are uniquely positioned thanks to our regulatory marketing authorizations, extensive distribution network, intellectual property, and comprehensive feature set. We believe that this combination not only differentiates us from our competitors but also solidifies our commitment to extending the benefits of our technology to every infant. 
+Our competition spans from established players to emerging innovators in the space, including: 
+• VTech: Sells an extensive range of low-cost sound and video monitors. 
+• Nanit: Offers a line of video monitors and non-FDA cleared integrated breathing wrap wearable. 
+• Masimo: Primarily focused on patient monitoring solutions for hospital and clinical settings. 
+• Hubble: Delivers a variety of low-cost sound and video monitors, including options with non-FDA cleared wearable health monitoring capabilities. 
+We expect the industry in which we operate will continue to evolve and may be significantly affected by new product introductions and other market activities of industry participants. Certain potential competitors have substantially greater capital resources, larger product portfolios, larger user bases, larger sales forces and greater geographic presence, and have built relationships with retailers and distributors that may be more effective than ours. Our products and services face additional competition from companies developing products and services for use with third-party monitoring systems, as well as from companies that currently market similar products and 
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+services of their own and may face further pressure from technology companies that have not historically operated in our industry. 
+Continuing technological advances and new product introductions within the home-use childcare electronics, medical monitoring and service industry place our products and services at risk of obsolescence. Our long-term success depends upon the development and successful commercialization of new products and services, new or improved technologies and additional applications for our existing technologies, including products or applications that may be subject to the oversight of the FDA or comparable foreign regulatory authorities and could require marketing authorization by the FDA or similar approval, clearance, authorization or certification from comparable foreign regulatory authorities or notified bodies. The research and development process is time-consuming and costly and may not result in products and services or applications that we can successfully commercialize. 
+We believe that the primary competitive factors in our market are: 
+• product quality and performance, including the size, quality, comfort, battery life, reliability, connectivity of the device to the application and/or monitor, and accuracy of our data provided to customers; 
+• FDA marketing authorizations and similar foreign regulatory authorities marketing authorizations and notified bodies certifications; 
+• customer purchasing experience; 
+• pricing; 
+• product support and service; 
+• effective marketing and education; 
+• brand recognition; 
+• breadth and depth of offerings; 
+• greater market penetration; 
+• technological innovation, product enhancements and speed of innovation; and 
+• sales and distribution capabilities. 
+We believe our ability to continue to compete effectively in our industry will also depend in part on our ability to respond more quickly and effectively than our peers to new or changing opportunities, technologies, regulatory standards or customer requirements. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and distribution strategies and as new companies enter the market with new technologies and distribution strategies. With our 510(k) clearance and de novo authorization, competitors will also have the benefit of using our devices as predicate devices in their own regulatory clearance pursuits. Increased competition in the future could adversely affect our revenue, revenue growth rate, margins and market share. 
+We believe that Owlet's pioneering spirit and commitment to innovation have advanced our recognition as a leader in infant health monitoring but also as a trusted partner for parents worldwide, aiming to enhance the safety and well-being of every baby. As we pursue additional marketing authorizations from applicable regulatory authorities and certification from notified bodies, we believe Owlet could be positioned as a category leader with significant competitive barriers. 
+Research and Development 
+We are committed to ongoing research and development to create new products and improve the design, operation, and quality of existing products. Our research and development organization includes individuals with expertise in fields including engineering, product design, clinical science, consumer electronics, healthcare technologies and embedded software design. Our technical capabilities and commitment to innovation have allowed us to deliver significant product enhancements on a rapid development timeline. In 2024, we developed our subscription offering, Owlet360. From designing innovative and groundbreaking products to employing sophisticated software with proprietary algorithms and backend support, we believe we have built a strong competitive moat and early-mover advantage over potential competition in the connected nursery field. We also have the benefit of a vast infant data set obtained in the consumer setting which leads to stronger insights and allows us to develop better products and services, which we believe in turn leads to happier users and drives product purchases. 
+Our current research and development efforts are focused on enhancing the customer experience of our existing products, enhancing the feature set of our subscription offering, and new product development, while supporting commercialization of our medical devices. These efforts may include pursuing development of expanded indications 
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+for our medical devices, such as expanded intended populations, that could include infants less than one month old, as well as developing new ways to deliver information that parents and caregivers value in their user experiences. 
+Harnessing the pediatric data set we have accumulated presents an opportunity to positively impact infant care and advance medical knowledge. Through strategic collaboration with healthcare professionals, establishment of clinical research initiatives, and innovative service offerings, we can leverage this wealth of information to enhance the well-being of infants and their families. 
+Integrating our findings into new service offerings represents the next frontier in infant care innovation. By leveraging subscription-based models, we can provide families with access to valuable insights, personalized recommendations, and ongoing support tailored to their child's developmental journey and empower parents to make informed decisions and nurture their child's health and well-being with confidence. 
+Regulatory Interactions 
+In October 2021, we received a Warning Letter from the FDA regarding the health notifications then provided with our Smart Sock that led Owlet to cease the distribution of Smart Sock in the U.S. (the “Warning Letter”). Since the Warning Letter, we have cooperated with and have worked diligently to seek marketing authorizations for our products with medical device functionality. In 2023, Owlet reached an important inflection point from a pioneer in the consumer-facing, in-home, digital health smart baby monitoring industry to a company that received two innovative regulatory authorizations from the FDA for its products. In June 2023, Owlet received a clearance of a premarket notification submitted to FDA pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k) clearance”) for its prescription-required pulse oximeter device, BabySat, which is indicated for spot-checking and/or continuous monitoring of certain well-perfused infants in the home environment. In November 2023, Owlet then received a first-of-its kind, de novo authorization from the FDA for Dream Sock, enabling both displays of a baby’s live health readings, including pulse rate and oxygen saturation level, and as well as Health Notifications, which will alert caregivers with lights and alarm sounds if their infant’s readings fall outside of preset ranges. These notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant and provide more helpful data in those moments. The FDA’s marketing authorizations for both BabySat and Dream Sock are significant foundational breakthroughs in our journey to bring care to the home and empower parents, to signify not only our commitment to innovation in the infant health category, but more importantly, our dedication to helping ensure the health and well-being of every baby. These clearances transform Owlet from solely a consumer technology company into a medical device company. 
+After Owlet received 510(k) clearance for its prescription-required pulse oximeter device, BabySat, which is indicated for spot-checking and/or continuous monitoring of certain well-perfused infants in the home environment, Owlet launched in the United States in January 2024 this FDA-cleared pulse-oximetry technology incorporating our advanced, wire-free and consumer-adopted sock design. BabySat, which requires a prescription from a physician or other authorized, licensed healthcare provider, has allowed Owlet to enter the medical and healthcare markets and compete with traditional hospital dispensed medical devices. BabySat is designed to be able to be utilized by various telehealth platforms and is designed specifically for babies with diagnosed illnesses and health conditions. The device uses pulse oximetry technology and is intended to be prescribed by physicians to assist with the in-home monitoring of babies under a physician’s care. The device is designed to provide alerts to parents when their baby’s heart rate or oxygen saturation level (or SpO2) does not fall within prescribed ranges. We believe BabySat provides significant advantages to the large, wired hospital monitoring technologies on the market today with its wireless, wearable form factor and cloud connected data integration designed for home use. 
+While our existing primary market is the United States, we have continued to expand into international and new geographic markets. Dream Sock has been CE and UKCA marked, as defined below, under European Union (“EU”) and United Kingdom (“UK”) Medical Device Regulations. As our retail penetration increases and brand awareness grows outside of the United States, we intend to further leverage retail channels and locations to ensure efficient and strategic global customer acquisition in key markets in the future. 
+Government Regulation 
+Certain of our products or their features and our operations are subject to regulation by the FDA and other federal and state authorities in the U.S., as well as comparable authorities in foreign jurisdictions. 
+U.S. Regulation 
+The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure 
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+that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the Federal Food, Drug, and Cosmetic Act (“FDCA”). 
+FDA Premarket Clearance and Approval Requirements 
+Unless an exemption applies, each medical device commercially distributed in the U.S. requires either FDA clearance of a premarket notification submitted under Section 510(k) of the FDCA or approval of a premarket approval application, or PMA. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents. 
+While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed. 
+510(k) Clearance Marketing Pathway 
+To obtain 510(k) clearance, we must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months but may take longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition, FDA collects user fees for certain medical device submissions and annual fees and for medical device establishments. 
+If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the “ de novo ” process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. 
+After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until such marketing authorization has been granted. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties. 
+De Novo Classification 
+Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on 
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+the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug Administration Safety and Innovation Act, or FDASIA, in July 2012, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent. FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination. 
+Over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products. 
+PMA Approval Pathway 
+Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR. 
+The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval. 
+Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness. 
+Clinical Trials 
+Clinical trials are almost always required to support a PMA and de novo classification and are sometimes required to support a 510(k) submission. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such trials. 
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+A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval. 
+Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may impose additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and complying with labeling and record-keeping requirements. In some cases, an IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects. 
+Post-market Regulation 
+After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include: 
+• establishment registration and device listing with the FDA; 
+• QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; 
+• labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or approved products; 
+• requirements related to promotional activities; 
+• clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices; 
+• medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; 
+• correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; 
+• the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and 
+• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device. 
+Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. As a manufacturer, we are subject to periodic scheduled and unscheduled inspections by the FDA. Failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. The discovery of previously unknown problems with any marketed products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or approval, or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. 
+12 
+The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: 
+• warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; 
+• recalls, withdrawals, or administrative detention or seizure of our products; 
+• operating restrictions or partial suspension or total shutdown of production; 
+• refusing or delaying requests for 510(k) clearance or PMA approvals of new products or modified products; 
+• withdrawing 510(k) clearances or PMA approvals that have already been granted; 
+• refusal to grant export approvals for our products; or 
+• criminal prosecution. 
+Low Risk General Wellness Products 
+The FDA has established a compliance policy for certain products that may fall within the definition of a medical device, but that are intended for only “general wellness use” and present a low risk to the safety of users and other persons. The FDA defines a “general wellness use” to be (i) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (ii) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. For example, the FDA identifies sleep management – such as a product intended to track sleep trends – as an intended use of a product that falls within a general wellness use, provided that the product claims do not make reference to any diseases or conditions As such, if a medical device includes features that fall within the definition of a “low risk general wellness product,” those features may not be subject to enforcement of medical device requirements under the FDA’s compliance policy for such products and/or features. 
+Foreign Government Regulation 
+In addition to U.S. regulations, we are subject to a variety of foreign government regulations applicable to general consumer products and medical devices. 
+Regulation of General Consumer Products in the European Union 
+In the European Union (“EU”), since December 13, 2024, consumer products must comply with the General Product Safety Regulation (EU) 2023/988 which repealed and replaced Directive 2001/95/EC. The Regulation covers all products intended for consumers (and products designed exclusively for professional use but which subsequently reach the consumer market), placed onto the EU market, unless a specific product safety regulation applies. The General Product Safety Regulation strengthened the safety and conformity requirements as well as post-market surveillance obligations for manufacturers and importers. Manufacturers must undertake and document a conformity assessment that covers the risks and risk categories associated with the product. The recommended method of undertaking such an assessment is through the application of voluntary European Harmonized Standards, but other options are available, such as using European Commission guidelines and using product safety codes of good practice. The required conformity assessment consists of a self-assessment with no requirement to involve a third party. Manufacturers also have the obligation to report to the national competent authorities of the different EU member states any risks to the consumer that are incompatible with the general safety requirements. The Regulation further imposes other obligations such as collecting information related to use of products after they have been made available to consumers. 
+The General Product Safety Regulation also increased market surveillance powers. National authorities have more powers to conduct more effective inspections of products and take action against unsafe ones. 
+Unlike directives, which must be implemented into the national laws of the EU member states, regulations are directly applicable (i.e., without the need for adoption of EU member state laws implementing them) in all EU member states and are intended to eliminate current differences in the regulation of consumer products among EU member states. Penalties applicable to infringements of regulations remain mainly determined at national-level. 
+Additional regulations may apply to our products and impose further requirements, including the possible 
+Additional regulations may apply to our products and impose further requirements, including the possible application of EU Regulation No 1007/2011 on textile products, which imposes specific labeling and marking 
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+requirements. In addition, we may also need to comply with requirements set forth by RoHs Directive No 2011/65/EU, which imposes specific restrictions on the use of hazardous substances in electrical and electronic equipment, and/or the Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) Regulation (EU) No 1907/2006, which restricts substances of very high concern and imposes substance registration requirements. 
+The advertising and promotion of consumer products is subject to EU directives concerning misleading and comparative advertising and unfair commercial practices and specific EU member state legislation governing the advertising and promotion of these products. 
+The aforementioned EU rules are generally applicable in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. 
+Regulation of Medical Devices in the European Union 
+The EU has adopted specific directives and regulations regulating the design, manufacture, clinical investigations, conformity assessment, labeling and adverse event reporting for medical devices. Until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC (the “EU Medical Devices Directive”), which has been repealed and replaced by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation”). Unlike the EU Medical Devices Directive, the EU Medical Devices Regulation is directly applicable in all EU member states without the need for member states to implement it into national law. 
+In the EU, there is currently no premarket government review of medical devices. However, all medical devices placed on the market in the EU must meet the relevant general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. The medical device must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. The European Commission has adopted various standards applicable to medical devices. These include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the general safety and performance requirements as a practical matter as it creates a rebuttable presumption that the device satisfies that general safety and performance requirement. 
+Compliance with the general safety and performance requirements of the EU Medical Devices Regulation is a prerequisite for European conformity marking (CE mark) without which medical devices cannot be marketed or sold in the EU. To demonstrate compliance with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the general safety and performance requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence. Except for low-risk medical devices (Class I), where the manufacturer can self-assess the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility or metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market. A notified body would typically audit and examine a product’s technical dossiers and the manufacturer's quality system (notified body must presume that quality systems which implement the relevant harmonized standards – which is ISO 13485:2016 for Medical Devices Quality Management Systems – conform to these requirements). If satisfied that the relevant product conforms to the general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EU. 
+Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements. In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s). 
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+The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to the European Database for Medical Devices (“EUDAMED”), unless they have already registered. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database. These new requirements aim at ensuring better identification and traceability of the devices. Each device – and as applicable, each package – will have a UDI composed of two parts: a device identifier (UDI-DI) specific to a device, and a production identifier (UDI-PI) to identify the unit producing the device. Manufacturers are also notably responsible for entering the necessary data on EUDAMED, which includes the UDI database, and for keeping it up to date. Certain obligations for registration in EUDAMED are expected to become applicable in the first quarter of 2026 (as EUDAMED is not yet fully functional). Until EUDAMED is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators. 
+All manufacturers placing medical devices into the market in the EU must comply with the EU medical device vigilance system which has been reinforced by the EU Medical Devices Regulation. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through EUDAMED – once functional – and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors such as the economic operators in the supply chain will also be informed. Until EUDAMED is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to apply. Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration in the characteristics or performance of a device on the market (e.g., inadequacy in the information supplied by the manufacturer, undesirable side-effect), which, directly or indirectly, might lead to either the death or serious deterioration of the health of a patient, user, or other persons, or to a serious public health threat. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports. 
+The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the EU Medical Devices Regulation, only devices that are CE marked may be marketed and advertised in the EU in accordance with their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, for example, requiring that advertisements are evidenced, balanced and not misleading. Specific requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals. 
+Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the U.S., on medical device manufacturers. Certain countries also mandate implementation of commercial compliance programs. The aforementioned EU rules are generally applicable in the EEA. 
+In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with regulatory requirements (as applicable) could require time and resources to respond to the regulatory authorities' observations and to implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement powers and if such issues cannot be resolved to their satisfaction can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties. 
+15 
+Brexit and Regulation of Medical Devices in the United Kingdom 
+Since the end of the Brexit transition period on January 1, 2021, Great Britain (England, Scotland and Wales) has not been directly subject to EU laws, however under the terms of the Protocol on Ireland/Northern Ireland, EU laws generally apply to Northern Ireland. 
+The EU laws that have been transposed into UK law through secondary legislation remain applicable in Great Britain, however, new legislation such as the EU Medical Devices Regulation is not applicable in Great Britain. 
+The UK government has passed the Medicines and Medical Devices Act 2021, which introduced delegated powers in favor of the Secretary of State or an ‘appropriate authority’ to amend or supplement existing regulations in the area of medicinal products and medical devices. This allows new rules to be introduced in the future by way of secondary legislation, which aims to allow flexibility in addressing regulatory gaps and future changes in the fields of human medicines, clinical trials and medical devices. 
+The EU-UK Trade and Cooperation Agreement (“TCA”) came into effect on January 1, 2021. The TCA does not specifically refer to medical devices but does provide for cooperation and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and measures, standardization related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For medical devices that are locally manufactured but use components from other countries, the “rules of origin” criteria will need to be reviewed. 
+Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has become the sovereign regulatory authority responsible for Great Britain. New regulations require all medical devices to be registered with the MHRA, and since January 1, 2022, manufacturers based outside the UK have been required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA. 
+Furthermore, on December 16, 2024, the UK government published an amendment to the Medical Devices Regulations 2002 (UK Medical Devices Regulations) to clarify and strengthen the post-market surveillance requirements for medical devices in Great Britain. This amendment will come into force on June 16, 2025, and aims to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients. In addition, the MHRA launched a consultation between November 14, 2024 and January 5, 2025 on proposals to update the pre-market requirements for medical devices in Great Britain, covering four topics, namely: (1) a new international reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country; (2) the new UKCA mark and, in particular, proposals to remove the requirement to place such UKCA marking on devices; (3) conformity assessment procedures for in vitro diagnostic devices; and (4) maintaining in UK law certain pieces of “assimilated” EU law which are due to sunset in 2025. This consultation builds on the MHRA’s previous consultation between September and November 2021, and the UK government’s response to that consultation which was published on June 26, 2022. The MHRA has stated that it will incorporate feedback to its recent consultation into new legislation on pre-market requirements for medical devices in Great Britain. The new legislation is expected to be implemented in 2026 and aims to enable greater international collaboration and practices, with more patient-centered, proportionate requirements for medical devices which are responsive to technological advances. 
+Under the UK Medical Devices Regulations, in order to be lawfully placed on the Great Britain market, class I (non-sterile, non-measuring or non-re-useable) medical devices need to be “UKCA” self-certified, and other medical devices need to be “UKCA” certified by a UK approved body. However, certain medical devices in compliance with: (1) the EU Medical Devices Directive can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2028; or (2) the EU Medical Devices Regulation can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030. 
+Under the terms of the Ireland/Northern Ireland Protocol, Northern Ireland follows EU rules on medical devices, including the EU Medical Devices Regulation, and medical devices marketed in Northern Ireland require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing the device on the market in Northern Ireland. Alternatively, if a UK approved body conducts such assessment, a ‘UKNI’ mark and a CE mark are applied and the device may only be placed on the market in Northern Ireland and not the EU. 
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+Other Foreign Regulations 
+Similarly, we are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of: 
+• design, development, manufacturing, and testing; 
+• product standards; 
+• product safety; 
+• product safety reporting; 
+• marketing, sales, and distribution; 
+• packaging and storage requirements; 
+• labeling requirements; 
+• content and language of instructions for use; 
+• record keeping procedures; 
+• advertising and promotion; 
+• recalls and field corrective actions; 
+• import and export restrictions; and 
+• tariff regulations, duties, and tax requirements; 
+We may also become subject to the following additional requirements in many foreign countries in which we may sell future medical devices, including in the areas of: 
+• clinical testing; 
+• post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; 
+• registration for reimbursement; and 
+• necessity of testing performed in country by distributors for licensees. 
+Other Healthcare Laws and Regulations 
+Coverage and Reimbursement 
+Sales of any product that we may develop and for which we may obtain marketing authorization or certification from the FDA and/or comparable foreign regulatory authorities or notified bodies depend, in part, on the extent to which such product or services associated with such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product or services associated with such product by third-party payors. Even though a new product may have been cleared or otherwise authorized, or certified for commercial distribution by the FDA, foreign regulatory authorities or notified bodies, we may find limited demand for the product unless and until reimbursement approval has been obtained from governmental and private third-party payors. 
+With respect to Dream Sock and Owlet Cam, we utilize a direct-to-consumer model where consumers purchase our products directly from us or one of our retailers. Currently, these products are not covered or reimbursed by any third-party payor. 
+Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical devices and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover the product or the services associated with the product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales. 
+Healthcare Fraud and Abuse 
+17 
+Federal and state governmental agencies and equivalent foreign authorities subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. These laws constrain the sales, marketing and other promotional activities of medical device manufacturers by limiting the kinds of financial arrangements we may have with hospitals, physicians and other potential purchasers and prescribers of our products. Federal healthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursable under Medicare, Medicaid, or other federally funded healthcare programs. The laws that may affect our ability to operate include: 
+• the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, arrangement for, or recommendation of, items or services for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value, and the government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of, or a specific intent to violate, the law; 
+• the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds; knowingly making, using, or causing to be made or used, a false record or statement to get a false claim paid or to avoid, decrease, or conceal an obligation to pay money to the federal government. A claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Actions under the False Claims Act may be brought by the government or as a qui tam action by a private individual in the name of the government and to share in any monetary recovery. There are also criminal penalties for making or presenting a false or fictitious or fraudulent claim to the federal government; 
+• the federal Health Insurance Portability and Accountability Act of 1996, which imposes criminal and civil liability for, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up a material fact or making a materially false, fictitious, or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items, or services; 
+• the federal Civil Monetary Penalties law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; 
+• the federal Physician Payment Sunshine Act, implemented by the Centers for Medicare & Medicaid Services (“CMS”) as the Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS, information related to payments and other “transfers of value” made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (including physician assistants and nurse practitioners), and teaching hospitals, and requires applicable manufacturers to report annually to CMS ownership and investment interests held by physicians and their immediate family members and payments or other “transfers of value” to such physician owners; 
+• analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers and patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state beneficiary inducement laws, and state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. 
+Violations of any of the above laws may result in significant administrative, civil and criminal penalties, including imprisonment, exclusion from participation in federal health care programs, such as Medicare and Medicaid, significant fines, monetary penalties and damages, the restructuring or curtailment of our operations, imposition of compliance obligations and monitoring, and reputational harm. 
+18 
+Data Privacy and Security Laws 
+Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing. 
+Anti-Bribery and Corruption Laws 
+We may also be subject to similar anti-corruption legislation implemented in Europe through EU Member State laws and under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions. 
+Intellectual Property 
+Since inception, we have been methodical around our intellectual property strategy. We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights. As of February 15, 2025, we had 60 issued patents (with numerous others pending) and 49 registered trademarks. Our patents include utility patents covering technology ranging from placement of electrodes to the base of the baby monitor. We have foreign patents and patent applications pending in the EU, Australia, Brazil, Canada, China, and Thailand. Our issued patents with claims generally directed to an infant sock comprised of a sensing device in a sleeve in the sock and a strap are expected to expire in the U.S. and China in 2033. Our issued patents with claims generally directed to placement of fabric electrodes and assembly of such are each expected to expire in the U.S., the EU, Australia, China and Canada in 2038. Pending applications in the aforementioned countries will have expiration dates between 2034 and 2043. We continually review our development efforts to assess the existence and patentability of new intellectual property. 
+Our pending patent applications may not result in issued patents, and we cannot assure you that any current or subsequently issued patents will protect our intellectual property rights. Third parties may challenge certain patents issued to us as invalid, may independently develop similar or competing technologies or may design around any of our patents. We cannot be certain that any of the steps we have taken will prevent the misappropriation of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights in these countries as fully as in the U.S. 
+Manufacturing 
+We rely on several third-party suppliers for single source components used in our devices, including the WiFi chips, microcontrollers, batteries, accelerometers, temperature sensors, plastics and circuit boards. 
+We follow strict quality guidelines, including a detailed risk-based audit plan following our ISO certified quality management system that dictates how often and to what degree we audit our suppliers. We check all quality, regulatory, and safety standards for products that our contract manufacturers make. We deploy a robust manufacturer and supplier selection process including site audits, tooling design and setup quotes, open book pricing, quality specifications, and vendor guides. The Smart Sock and Dream Sock are currently manufactured at ISO 13485 certified required to adhere to specific quality requirements in accordance with the International Medical Device Regulators Forum (IMDRF) and Medical Device Single Audit Program (MDSAP). We received ISO 13485 and MDSAP certifications, as we work to implement and maintain the requirements applicable to medical device manufacturer quality management systems. We believe that third-party facilities are adequate to meet our current and anticipated manufacturing needs. We do not currently plan to manufacture our products or any related components ourselves. 
+Manufacturing Services Agreement with Benchmark Electronics 
+In October 2017, we entered into a manufacturing services agreement with Benchmark Electronics, Inc. (“Benchmark”), pursuant to which Benchmark provides us certain manufacturing and related services for the production of Dream Sock, Smart Sock, BabySat, and Dream Duo offerings out of its facilities in Thailand, including procuring materials and assembling and testing finished products. 
+19 
+The initial term of the agreement was one year and automatically extends for additional one-year periods until either we or Benchmark provide notice of non-renewal at least 90 days prior to the end of the then-current term or extension. Among other things, either party may terminate the agreement for convenience upon 90-day notice, in the case of Owlet, or 180 day notice, in the case of Benchmark, to the other party. Either party may also terminate the agreement under certain other customary conditions, including if the other party materially breaches the agreement, for uncured breaches of the agreement, or in the event of the other party’s insolvency. Benchmark has exclusive manufacturing rights through May 31, 2027 for Owlet Sock and Duo products, including all revisions and future generations of those products and/or product families. 
+In connection with the services provided under the agreement, we have agreed to indemnify Benchmark against certain claims, including infringement of third-party intellectual property rights and noncompliance of our products with safety or other regulations. We are also entitled to customary indemnification rights, subject to certain caps. 
+Manufacturing Services Agreement with Aoni 
+In June 2018, we entered into a manufacturing and supply agreement with Shenzhen Aoni Electronic Co., Ltd (“Aoni”), pursuant to which Aoni provides certain manufacturing and related services for the production of our Owlet Cam product, including procuring materials and assembling and packaging finished products. 
+We have extended the term of the agreement several times following the expiration of the initial term of the agreement, and most recently extended the term through June 2026. We have the right to terminate the agreement, without cause, upon six months’ prior written notice to Aoni. Additionally, either party may terminate the agreement under certain other customary conditions, including for uncured breaches of the agreement or in the event of the other party’s insolvency. 
+In connection with the services provided under the agreement, Aoni has agreed to indemnify us against certain claims and liabilities, including claims arising in connection with product defects, breach of the agreement, negligence and violations of applicable law. 
+Network Hosting 
+We currently host our products and services, serve our customers and support our operations primarily from third-party data and call centers and other cloud-based services. For example, we rely on cloud services and bespoke software services provided by Ayla Networks for our Dream Sock and Smart Sock products to support the transfer of data to the cloud and back to us and the user. 
+Environmental Matters 
+Our operations, properties and products are subject to a variety of U.S. and foreign environmental laws and regulations governing, among other things, air emissions, wastewater discharges, management and disposal of hazardous and non-hazardous materials and waste and remediation of releases of hazardous materials. We believe, based on current information, that we are in material compliance with environmental laws and regulations applicable to us. However, our failure to comply with present and future requirements under these laws and regulations, or environmental contamination or releases of hazardous materials on our leased premises, as well as through disposal of our products, could cause us to incur substantial costs, including clean-up costs, personal injury and property damage claims, fines and penalties, costs to redesign our products or upgrade our facilities and legal costs, or require us to curtail our operations, any of which could seriously harm our business. 
+Human Capital Resources 
+As of December 31, 2024, we had 80 full-time employees and 5 part-time employees. None of our employees is represented by a labor union, and we consider our employee relations to be good. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards. 
+We believe our innovation and operational excellence stems directly from our community and our common commitment to inclusion and equal access to healthcare. One cornerstone of our approach lies in our belief that every baby deserves access to monitoring, regardless of their background or circumstances. Through Owlet Cares, our advocacy initiative, we are dedicated to making a positive impact in the lives of babies and parents. We recognize that parenthood is a journey marked by a range of experiences, challenges, and joys. As such, we are dedicated to supporting all parents from a rich tapestry of backgrounds and perspectives. 
+20 
+Corporate Information 
+Owlet Baby Care Inc. was incorporated in Delaware on February 24, 2014 as a Delaware corporation. SBG was incorporated in Delaware on June 23, 2020. On July 15, 2021, SBG closed the Merger with Owlet Baby Care Inc. As a result of the Merger, Owlet Baby Care, Inc. became a wholly-owned subsidiary of SBG, and SBG changed its name to Owlet, Inc. 
+Available Information 
+Our website address is www.owletcare.com. The contents of, or information accessible through, our website are not part of this Annual Report on Form 10-K. We make our filings with the SEC, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, as well as beneficial ownership filings available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish such reports to, the SEC. 
+We may use our website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at https://investors.owletcare.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address under the “Resources” menu on the Investors section of our website at https://investors.owletcare.com. 
+The reference to our website address does not constitute incorporation by reference of the information contained on or available through our website, and you should not consider such information to be a part of this Annual Report on Form 10-K.

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+Item 13. 
+Certain Relationships and Related Transactions, and Director Independence 
+125

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+cik,ticker,company_name,year,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url
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+Item 1. Business 
+We are Owlet 
+Owlet is a leading pediatric health platform and the only company globally to offer U.S. FDA-cleared and internationally medically-certified wearable pediatric monitors for home use. By delivering hospital-grade technology through a consumer-friendly interface, we bridge the critical gap between clinical care and the home. 
+Our ecosystem—comprising clinically tested monitoring systems, an integrated video platform, and an intuitive mobile app—supports families from "night one" and throughout the most challenging parts of the parenting journey. Since 2012, more than 2.5 million parents have trusted Owlet to provide the real-time insights in support of their child's well-being and to promote restful sleep for the entire family. 
+Globally, over 140 million new lives are brought into the world every year. While welcoming a new child is a meaningful milestone for families, the first year of life is often marked by sleep disruption, health concerns, and increased stress for caregivers. In the United States alone, we estimate families lose an average of 44 nights of sleep in the first year, and young children account for millions of annual sick visits and emergency room consultations. 
+We believe these challenges underscore a dire need for a paradigm shift in pediatric wellness. Rather than relying solely on reactive care, Owlet enables a more proactive, data-informed approach to infant and early childhood health. We are moving beyond simple monitoring to provide a comprehensive window into a child's health, helping parents stay informed, get more rest, and find lasting peace of mind. 
+Our vision is to become the world’s most trusted parenting platform, providing insights and care for every family. We are committed to: 
+• Guiding parents through the unknown: Delivering real-time, clinically grounded insights that help families navigate the earliest stages of parenting with confidence. 
+• Supporting health, safety and sleep: Prioritizing the core needs of the early years to improve well-being for both children and caregivers. 
+• Leading in pediatric data and insights: Leveraging one of the world’s largest datasets of pediatric health and sleep information to drive continuous innovation, personalized experiences, and responsible integration with the broader healthcare ecosystem. 
+By pairing advanced medical technology with human-centric design and AI-powered intelligence, Owlet is building more than a monitoring solution. We are building a platform that advances health and wellness outcomes for families and fosters a trusted partnership with parents that begins on night one and continues well beyond. 
+Products and Services 
+Our integrated platform delivers a dual-value proposition: medical-grade monitoring for health and safety and data-driven insights for long-term family wellness. 
+Owlet provides medically certified, over-the-counter wearable monitors that bring hospital-grade technology into the home. Our wearable sensors provide a notification to the caregiver when a child’s pulse rate and/or oxygen saturation values moves outside of preset ranges (“Health Notifications”) and displays the child’s live pulse rate and oxygen saturation values and trends (“Live Health Readings”). This combination creates a medical-grade safety net designed to provide parents with the security of knowing they will be alerted when their attention is required. 
+Beyond health monitoring, our software services transform physiological data into actionable guidance, helping parents get more sleep and provide more informed care. We leverage one of the world's largest pediatric datasets to provide parents with personalized data and insights. By analyzing sleep trends and health patterns, we empower caregivers to make informed decisions and shift from reactive monitoring to proactive wellness. These app-based services are designed to reduce uncertainty during the early months of the parenting journey. By providing a clear window into a child’s well-being, our software services can help reduce parental anxiety and enable a more restful home environment. This emphasis on clarity and confidence helps families feel safe, well-rested, and supported in their daily routines. 
+Dream Sock: An award-winning wearable infant health monitor equipped with pulse oximetry technology that tracks vital signs, including pulse rate, oxygen level, activity, and sleep patterns. It delivers real-time notifications to caregivers when pulse rate and/or oxygen saturation values fall outside preset ranges and provides tailored sleep insights in the Owlet Dream App. Dream Sock with Live Health Readings and Health Notifications has received FDA marketing authorization in the United States, and has regulatory clearances in the European Union, United Kingdom, Australia, South Africa, India, and Israel. A version of Dream Sock without Live 
+3 
+Health Readings and Health Notifications is available in Canada and tracks Sleep Quality Indicators, including heart rate and 10-minute historic average oxygen levels. Dream Sock is the next-generation monitor that replaced our legacy Smart Sock product. 
+BabySat: Designed for infants who may benefit from additional monitoring at home under the supervision of a physician. It is a prescription version of our wearable monitor that offers customizable alarm limits through the Owlet Care+ App. This device is best suited for infants with conditions such as RSV, pneumonia, bronchitis, croup, or other diagnoses. Supported by insurance reimbursement, eligible families may access vital monitoring at low or no cost. BabySat is FDA-cleared and available in the U.S. only. The BabySat pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation values of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment. 
+Dream Sight: A smart audio and video monitor that enables parents to monitor their child from anywhere. It features Wi-Fi enabled 2k HD video, motion and cry detection, 4x zoom, and two-way audio to help caregivers stay connected regardless of distance. Dream Sight is the first baby monitor to receive the SGS Cybersecurity Mark, a global certification that recognizes high standards of digital safety and privacy. 
+Dream Duo: Integrates Dream Sock and Dream Sight to create a connected health and safety system, combining biometric monitoring, sleep analytics, and HD video to provide deeper visibility into a child’s well-being. 
+Owlet360: Owlet’s innovative subscription service leverages the Company’s pediatric health and sleep data to provide parents and caregivers with a deeper, personalized understanding of their child’s development, health, and sleep trends. The service provides caregivers with actionable information designed to support informed decision-making and greater peace of mind. Owlet360 is available to all new and existing Owlet Dream App users in English-speaking markets such as the United States, United Kingdom, Ireland, South Africa, Australia and New Zealand. We plan to expand access to Owlet360 in additional languages and other international markets in 2026. 
+Accessories: Enhancing the Owlet experience, offered accessories include fabric accessory socks in various colors and patterns, and the Owlet Sock Travel Case. 
+Our Platform and Pipeline 
+Since our inception, over 2.5 million Owlet devices have been sold worldwide, generating one of the largest proprietary data sets of infant health and sleep. We believe that data is an invaluable tool in bridging the current healthcare gap between hospital and home, and that through leveraging our data, our platform can improve access to individualized care. We plan on continuing to develop our software and data insights in order to bring additional solutions into the home. 
+We are building our data platform with the goal to be parents’ go-to wellness brand in the areas of sleep, safety, health and well-being information. We will remain focused on commercializing our Dream Sock and BabySat devices, which we believe will open the door to launch additional services to continue the expansion of our data platform. We believe that we can use our data sets to enhance our product with additional valuable data insights as part of new subscription models and increasingly predictive technologies. 
+We believe we have developed deep and enduring relationships with our users and brand advocates around the world. We believe these parents are more likely to be early technology adopters and have a high affinity towards actionable insight to care for their children. This is evidenced by the millions of downloads of the Owlet applications and high social media engagement across our multiple platforms. We expect these relationships continue to grow and develop in tandem with our novel product and software additions to our connected ecosystem, feature enhancements, omni-channel distribution, and marketing efforts. As and to the extent we are able to bring this valued relationship with consumers into new medical communities, we believe that our platforms will continue to evolve and expand. 
+Go-to-Market Channels 
+Owlet products are marketed and distributed in the United States and internationally through consumer and, more recently, through healthcare distribution channels. 
+Direct to Consumer & Digital Engagement: The Owlet brand resonates deeply with over 1 million social media followers, hundreds of millions of views and engagements and millions of website visitors each year. Our focus on engaging directly with our customers is driving significant sales through direct channels and increases demand through our retail partnerships. Our digital presence is a cornerstone of our strategy, enhancing customer lifetime value and fostering brand loyalty. 
+Retail Partnerships: Our products are widely available across major U.S. retailers, including Amazon, Baby List, Best Buy. Target, and Walmart. 
+4 
+Global Reach & Distribution: Our international strategy continues to grow, with distribution partners in key global markets including Canada, Australia, the United Kingdom and throughout the rest of the European Union. We intend to continue expanding our global footprint and accessibility, underscoring our commitment to global health and well-being. 
+Healthcare Distribution & Insurance Reimbursement: The FDA clearance and subsequent launch of BabySat marks a significant opportunity to expand into healthcare distribution, opening potential new channels for insurance reimbursement and professional recommendations. We believe that this development not only broadens access, but also cements Owlet's role in the healthcare ecosystem. For example, we recently announced a new durable medical equipment (DME) partnership with 1 Natural Way, a leading national mom-and-baby-focused DME provider. Also, as further discussed below, we recently launched a collaboration with Children's Hospital of The Kings Daughters. Owlet is focused on enlisting a wide variety of healthcare partners to increase the accessibility and affordability of our products while increasing our margin. 
+Our Strategy 
+2025 - Year of Scale and Transformation 
+In 2025, we made significant progress in our transition from a hardware-centric company to a comprehensive pediatric health platform. Our monitoring devices are the foundation of our medical-grade ecosystem and throughout the year, we saw accelerated adoption of our Dream Sock, and expanded pathways for prescription and insurance reimbursement for our BabySat devices. We believe that our continued leadership as the provider of the first and only FDA-cleared baby monitors in the market has created strong brand awareness among parents and healthcare providers, directly addressing the safety and monitoring needs of our customers while fulfilling our commitment to regulatory excellence. 
+We have experienced growth and success in our currently active international markets, while we continue to pursue additional international certifications to broaden our global presence. We received regulatory clearance in India late in the year, paving the way for commercial launch in early 2026. This expansion demonstrates our ability to scale our innovative technology globally while maintaining the rigorous quality standards required by international health authorities. 
+A key pillar of our 2025 transformation was the rapid scaling of our digital services and data platform. Following its full launch in January 2025, our Owlet360 subscription service exceeded expectations, gaining over 98,000 subscribers by the end of 2025. The success of our product and platform strategies was reflected in a historic year for our financial performance. For the second consecutive year we set Company records in revenue, gross profit, gross margin and Adjusted EBITDA for the full year 2025. We recognized $105.7 million in revenue, representing approximately 35.4% growth year-over-year, and achieved 50.6% gross margin, improving 20 basis points year over year despite headwinds in global trade. Furthermore, in 2025 we reported a net loss of $39.7 million and achieved approximately $2.0 million in Adjusted EBITDA, our first full year of positive Adjusted EBITDA. For additional information on Adjusted EBITDA and a reconciliation to the most directly comparable GAAP equivalent, see Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations — Non-GAAP Financial Measures.” Our continued execution of our financial strategy, supported by a successful warrant exchange and follow-on equity offering in late 2025, has significantly strengthened our balance sheet, enabling us to invest more in our growth. 
+As we look toward 2026, we remain dedicated to our mission of providing every parent with the tools they need to keep their children safe. The progress made in 2025—marked by sustained growth, international scale, and the evolution of our subscription ecosystem—demonstrates that through continued strategy execution we continue to strengthen our operational, financial, and regulatory foundations. We believe we are well-positioned as a sustainable, data-driven leader in the pediatric health space, with a goal to deliver long-term value to our shareholders and life-changing technology to families worldwide. 
+Strategy Overview 
+Driving Growth: Our vision is clear - we see health sensing technology for children becoming as ubiquitous as car seats and breast pumps for newborns. With the momentum we have gained from FDA marketing authorizations, the launch of Owlet360 subscription service, the introduction of insurance coverage and reimbursement for BabySat, increased credibility in medical communities, and an increased retail presence, we see Owlet as strategically positioned for substantial growth. 
+We have outlined strategic focus areas that we believe are most critical to driving growth: 
+Drive Domestic Adoption: In 2024, we introduced FDA-cleared device Dream Sock to deliver improved comfort to parents wishing for better safety and monitoring for their children. Our de novo classification of Dream Sock as an over-the-counter device was the first of its kind, and Dream Sock is currently the only monitor on the market in our product category authorized by the FDA. We intend to leverage the differentiation and scale of Dream Sock to drive continued domestic adoption in the United States. 
+Drive International Adoption: We have received 7 international regulatory clearances for Dream Sock in addition to the United States including the European Union, United Kingdom, Australia, New Zealand, South Africa, India, and Israel. We are leveraging these endorsements of our technologies to drive expansion of our global footprint and are currently selling Owlet products in over 30 
+5 
+countries. We intend to continue to drive adoption in these current geographic sales channels as well as opening additional sales channels through regulatory clearances. 
+Expand the Owlet360 Subscription Platform: In January 2025, we launched Owlet360, our first subscription service. Owlet360 puts the value from Owlet’s vast pediatric health dataset of health and sleep information directly in the hands of parents and caregivers. Owlet360 is aimed to empower parents, at home, with information that can help them better manage care for their children. We believe that unlocking care at home is the key to improving overall infant health outcomes and reducing costs. Priced at $9.99 per month, we have grown our total paying subscribers to over 110,000. We anticipate introducing additional features, enhancements, and international expansion for Owlet360. This service helps to bridge the gap between hospital and home care, driving predictable recurring revenue, boosting lifetime value, and growing our connected ecosystem. 
+Grow the Healthcare Channels: In 2024, we introduced FDA-cleared device BabySat to offer an insurance reimbursable baby monitor, with a focus on newborns deemed high-risk. We believe that the FDA marketing authorization for BabySat is an important differentiation to gain trust of healthcare professionals, as well as parents desiring better safety and monitoring for their children. We have made progress in expanding our insurance coverage network, ending 2025 with 37 states on Medicaid reimbursement, and over 250 commercial insurance carriers. We also launched a consignment agreement with Children’s Hospital of The King’s Daughters through which providers can prescribe Owlet devices in the hospital, thereby enabling patients to obtain insurance prior-authorization prior to hospital discharge, and take home our medical-grade infant monitoring devices. This agreement represents an important milestone for our healthcare opportunity as we look to replicate this business model with other hospitals and medical facilities. 
+Expanding Lifetime Value (LTV): We view Owlet's brand as synonymous with engagement and loyalty in our industry, supported by a rich dataset that underpins our market understanding. Expanding our lifetime value is at the core of our strategy to support parents in the journey of parenthood. With the introduction of our Owlet360 subscription service and Dream Sight camera in 2025, we believe we are well-positioned to forge deeper connections among parents, their children, and healthcare providers, and deliver increasing lifetime value to all customers. Our strategy is not just about growth; it is about enriching the ecosystem of pediatric care with Owlet at its heart, fostering a healthier future for the next generation. 
+Market Landscape and Competitive Dynamics 
+Owlet has a clear and specific market in pediatrics serving the needs of parents and their children across key markets in the U.S., Europe, Australia, and Canada, with a product launch anticipated for India and other international markets throughout 2026. With over 33 million infants born annually in these regions, we see the potential for a steady demand for our products and refreshment of our Total Addressable Market ("TAM"). Despite declining birth rates in some regions, we believe the emphasis on infant care and the financial investment in the well-being of newborns have seen a consistent increases over the years. We believe this trend underscores a growing market resilience, notably within the baby care sector, which has remained robust against broader economic fluctuations affecting consumer spending. 
+Since its inception, Owlet has been at the forefront of the consumer digital health monitoring space for children and their families. We believe that our pioneering achievement of obtaining the first de novo authorization for at-home monitoring without the need for a prescription underscores our trailblazing efforts and helps set a high regulatory bar for new entrants in our industry. This distinction is critical as it denotes that any comparable product with medical applications will likely require similar regulatory endorsements. 
+In addition to spearheading the health monitoring category, Owlet competes within the broader realm of general video/audio baby monitors. We believe our strategic edge is encapsulated in Dream Duo, the combination product that includes Dream Sock and Dream Sight, which provides parents with a holistic view of their child's health and well-being. This product allows parents to see, hear, and be assured of their child's condition through our app, offering an unmatched value proposition. 
+We believe that we are uniquely positioned to address our market opportunity as a result of our regulatory marketing authorizations, extensive distribution network, intellectual property including our proprietary data, and comprehensive feature set. We believe that this combination not only differentiates us from our competitors but also solidifies our commitment to extending the benefits of our technology to every infant. 
+Our competition spans from established players to emerging innovators in the space, including companies that sell non-FDA cleared sound and video monitors. Owlet is the only company in the market to offer a baby monitor with FDA-clearance in addition to multiple international regulatory certifications. 
+We expect the industry in which we operate will continue to evolve and may be significantly affected by new product introductions and other market activities of industry participants. Certain potential competitors have substantially greater capital resources, larger product portfolios, larger user bases, larger sales forces and greater geographic presence, and have built relationships with retailers and distributors that may be more effective than ours. Our products and services face additional competition from companies developing products and services for use with third-party monitoring systems, as well as from companies that currently market similar products and services of their own and may face further pressure from technology companies that have not historically operated in our industry. 
+6 
+Continuing technological advances and new product introductions within the home-use childcare electronics, medical monitoring and service industry place our products and services at risk of obsolescence. Our long-term success depends upon the development and successful commercialization of new products and services, new or improved technologies and additional applications for our existing technologies, including products or applications that may be subject to the oversight of the FDA or comparable foreign regulatory authorities and could require marketing authorization by the FDA or similar approval, clearance, authorization or certification from comparable foreign regulatory authorities or notified bodies. The research and development process is time-consuming and costly and may not result in products and services or applications that we can successfully commercialize. 
+We believe that the primary competitive factors in our market are: 
+• product quality and performance, including the size, quality, comfort, battery life, reliability, connectivity of the device to the application and/or monitor, and accuracy of data provided to customers; 
+• FDA marketing authorizations and similar foreign regulatory authorities marketing authorizations and notified bodies certifications; 
+• customer purchasing experience; 
+• pricing; 
+• product support and service; 
+• effective marketing and education; 
+• brand recognition; 
+• breadth and depth of offerings; 
+• greater market penetration; 
+• technological innovation, product enhancements and speed of innovation; and 
+• sales and distribution capabilities. 
+We believe our ability to continue to compete effectively in our industry will also depend in part on our ability to respond more quickly and effectively than our peers to new or changing opportunities, technologies, regulatory standards or customer requirements. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and distribution strategies and as new companies enter the market with new technologies and distribution strategies. With our 510(k) clearance and de novo authorization, we believe competitors or new entrants will also have the benefit of using our devices as predicate devices in their own regulatory clearance pursuits. Increased competition in the future could adversely affect our revenue, revenue growth rate, margins and market share. 
+Research and Development 
+We are committed to ongoing research and development to create new products and enhance the design, operation, and quality of our existing offerings. Our research and development organization includes individuals with expertise in engineering, product design, clinical science, consumer electronics, healthcare technologies, data science, artificial intelligence, computer vision, and embedded software. Our technical capabilities and disciplined development processes enable us to deliver product enhancements on an accelerated timeline while maintaining a focus on reliability, security, and regulatory compliance. 
+In 2025, we successfully launched our subscription service, Owlet360, extending our platform from hardware-focused products to an integrated ecosystem of connected devices, software, and services. Ongoing research and development efforts are focused on expanding the capabilities, personalization, and overall value of this subscription offering across our product portfolio. 
+A core area of investment is the integration of artificial intelligence ("AI") and computer vision to our camera products. These technologies are being developed to improve environmental awareness, detection, and contextual understanding within the nursery, supporting more intelligent monitoring and enhanced user experiences over time. 
+We are also investing in AI-driven personalization for our wearable products. By leveraging machine learning techniques and longitudinal, anonymized data, we seek to deliver insights and experiences that adapt to a baby’s age, patterns, and developmental stage, while maintaining strong standards for data privacy and security. 
+In parallel, we continue to evaluate emerging wearable sensor technologies that may enable additional physiological measurements and new use cases beyond our current offerings, including temperature trends, hydration-related indicators, and other health signals. These initiatives remain in exploratory and feasibility stages. 
+Our current research and development activities are focused on enhancing the customer experience of our existing products, expanding subscription functionality, advancing new product development, and supporting the commercialization and regulatory pathways of our medical devices. These efforts may include pursuing expanded indications or intended populations, as well as developing improved methods for delivering information that parents and caregivers find meaningful and actionable. 
+7 
+We believe that responsibly leveraging the pediatric data we have accumulated through our products and services can support innovation in infant care and contribute to broader medical understanding. Through collaboration with healthcare professionals and participation in clinical research initiatives, we aim to translate these efforts into enhanced products and services that support families throughout early parenthood. 
+Regulatory Interactions 
+We have cooperated with and have worked diligently to seek marketing authorizations for our products with medical device functionality. In 2023, Owlet reached an important inflection point from a pioneer in the consumer-facing, in-home, digital health smart baby monitoring industry to a company that received two innovative regulatory authorizations from the FDA for its products. In June 2023, Owlet received a clearance of a premarket notification submitted to FDA pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k) clearance”) for its prescription-required pulse oximeter device, BabySat, which is indicated for spot-checking and/or continuous monitoring of certain well-perfused infants in the home environment. In November 2023, Owlet then received a first-of-its kind, de novo authorization from the FDA for Dream Sock, enabling both displays of a baby’s live health readings, including pulse rate and oxygen saturation values, as well as Health Notifications, which will alert caregivers with lights and alarm sounds if their infant’s readings fall outside of preset ranges. These notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant and provide more helpful data in those moments. The FDA’s marketing authorizations for both BabySat and Dream Sock are significant foundational breakthroughs in our journey to bring care to the home and empower parents, to signify not only our commitment to innovation in the infant health category, but more importantly, our dedication to helping ensure the health and well-being of every baby. These clearances transform Owlet from solely a consumer technology company into a medical device company. 
+After Owlet received 510(k) clearance for its prescription-required pulse oximeter device, BabySat, which is indicated for spot-checking and/or continuous monitoring of certain well-perfused infants in the home environment, Owlet launched in the United States in January 2024 this FDA-cleared pulse-oximetry technology incorporating our advanced, wire-free and consumer-adopted sock design. BabySat, which requires a prescription from a physician or other authorized, licensed healthcare provider, has allowed Owlet to enter the medical and healthcare markets and compete with traditional hospital dispensed medical devices. BabySat is designed to be able to be utilized by various telehealth platforms and is designed specifically for babies with diagnosed illnesses and health conditions. The device uses pulse oximetry technology and is intended to be prescribed by physicians to assist with the in-home monitoring of babies under a physician’s care. We believe BabySat provides significant advantages to the large, wired hospital monitoring technologies on the market today with its wireless, wearable form factor and cloud connected data integration designed for home use. 
+While our existing primary market is the United States, we have continued to expand into international and new geographic markets. Dream Sock has been CE and UKCA marked, as defined below, under European Union (“EU”) and United Kingdom (“UK”) Medical Device Regulations. Additional international clearances for Dream Sock include Australia, India, New Zealand, and South Africa. As our retail penetration increases and brand awareness grows outside of the United States, we intend to further leverage retail channels and locations to ensure efficient and strategic global customer acquisition in key markets in the future. 
+Government Regulation 
+Certain of our products or their features and our operations are subject to regulation by the FDA and other federal and state authorities in the U.S., as well as comparable authorities in foreign jurisdictions. 
+U.S. Regulation 
+The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the Federal Food, Drug, and Cosmetic Act (“FDCA”). 
+FDA Premarket Clearance and Approval Requirements 
+Unless an exemption applies, each medical device commercially distributed in the U.S. requires either FDA clearance of a premarket notification submitted under Section 510(k) of the FDCA or approval of a premarket approval application, or PMA. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation (“QMSR”), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents. 
+8 
+While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed. 
+510(k) Clearance Marketing Pathway 
+To obtain 510(k) clearance, we must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months but may take longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition, the FDA collects user fees for certain medical device submissions and annual fees and for medical device establishments. 
+If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. 
+After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until such marketing authorization has been granted. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties. 
+De Novo Classification 
+Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug Administration Safety and Innovation Act, or FDASIA, in July 2012, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent. FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination. The FDA's stated goal is to make a decision about a de novo classification request in 150 review days. 
+Over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products. 
+PMA Approval Pathway 
+Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct 
+9 
+a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QMSR. 
+The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval. 
+Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness. 
+Clinical Trials 
+Clinical trials are almost always required to support a PMA and de novo classification and are sometimes required to support a 510(k) submission. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such trials. 
+A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval. 
+Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may impose additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and complying with labeling and record-keeping requirements. In some cases, an IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects. 
+Post-market Regulation 
+After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include: 
+• establishment registration and device listing with the FDA; 
+• QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; 
+• labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or approved products; 
+10 
+• requirements related to promotional activities; 
+• clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices; 
+• medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; 
+• correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; 
+• the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and 
+• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device. 
+Manufacturing processes for medical devices are required to comply with the applicable portions of the QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QMSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. As a manufacturer, we are subject to periodic scheduled and unscheduled inspections by the FDA. Failure to maintain compliance with the QMSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. The discovery of previously unknown problems with any marketed products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or approval, or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. 
+The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: 
+• warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; 
+• recalls, withdrawals, or administrative detention or seizure of our products; 
+• operating restrictions or partial suspension or total shutdown of production; 
+• refusing or delaying requests for 510(k) clearance or PMA approvals of new products or modified products; 
+• withdrawing 510(k) clearances or PMA approvals that have already been granted; 
+• refusal to grant export approvals for our products; or 
+• criminal prosecution. 
+Low Risk General Wellness Products 
+The FDA has established a compliance policy for certain products that may fall within the definition of a medical device, but that are intended for only “general wellness use” and present a low risk to the safety of users and other persons. The FDA defines a “general wellness use” to be (i) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (ii) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. For example, the FDA identifies sleep management – such as a product intended to track sleep trends – as an intended use of a product that falls within a general wellness use, provided that the product claims do not make reference to any diseases or conditions. As such, if a medical device includes features that fall within the definition of a “low risk general wellness product,” those features may not be subject to enforcement of medical device requirements under the FDA’s compliance policy for such products and/or features. 
+Foreign Government Regulation 
+In addition to U.S. regulations, we are subject to a variety of foreign government regulations applicable to general consumer products and medical devices. 
+Regulation of General Consumer Products in the European Union 
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+In the European Union (“EU”), since December 13, 2024, consumer products must comply with the General Product Safety Regulation (EU) 2023/988 which repealed and replaced Directive 2001/95/EC. The Regulation covers all products intended for consumers (and products designed exclusively for professional use, but which subsequently reach the consumer market), placed onto the EU market, unless a specific product safety regulation applies. The General Product Safety Regulation strengthened the safety and conformity requirements as well as post-market surveillance obligations for manufacturers and importers. Manufacturers must undertake and document a conformity assessment that covers the risks and risk categories associated with the product. The recommended method of undertaking such an assessment is through the application of voluntary European Harmonized Standards, but other options are available, such as using European Commission guidelines and using product safety codes of good practice. The required conformity assessment consists of a self-assessment with no requirement to involve a third party. Manufacturers also have the obligation to report to the national competent authorities of the different EU member states any risks to the consumer that are incompatible with the general safety requirements. The Regulation further imposes other obligations such as collecting information related to use of products after they have been made available to consumers. 
+The General Product Safety Regulation also increased market surveillance powers. National authorities have more powers to conduct more effective inspections of products and take action against unsafe ones. 
+Unlike directives, which must be implemented into the national laws of the EU member states, regulations are directly applicable (i.e., without the need for adoption of EU member state laws implementing them) in all EU member states and are intended to eliminate current differences in the regulation of consumer products among EU member states. Penalties applicable to infringements of regulations remain mainly determined at national level. 
+Additional regulations may apply to our products and impose further requirements, including the possible application of EU Regulation No 1007/2011 on textile products, which imposes specific labeling and marking requirements. In addition, we may also need to comply with requirements set forth by RoHs Directive No 2011/65/EU, which imposes specific restrictions on the use of hazardous substances in electrical and electronic equipment, and/or the Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) Regulation (EU) No 1907/2006, which restricts substances of very high concern and imposes substance registration requirements. 
+The advertising and promotion of consumer products is subject to EU directives concerning misleading and comparative advertising and unfair commercial practices and specific EU member state legislation governing the advertising and promotion of these products. 
+The aforementioned EU rules are generally applicable in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. 
+Regulation of Medical Devices in the European Union 
+The EU has adopted specific directives and regulations regulating the design, manufacture, clinical investigations, conformity assessment, labeling and adverse event reporting for medical devices. Until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC (the “EU Medical Devices Directive”), which has been repealed and replaced by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation”). Unlike the EU Medical Devices Directive, the EU Medical Devices Regulation is directly applicable in all EU member states without the need for member states to implement it into national law. 
+In the EU, there is currently no premarket government review of medical devices. However, all medical devices placed on the market in the EU must meet the relevant general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. The medical device must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. The European Commission has adopted various standards applicable to medical devices. These include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the general safety and performance requirements as a practical matter as it creates a rebuttable presumption that the device satisfies that general safety and performance requirement. 
+Compliance with the general safety and performance requirements of the EU Medical Devices Regulation is a prerequisite for European conformity marking (CE mark) without which medical devices cannot be marketed or sold in the EU. To demonstrate compliance with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the general safety and performance requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the 
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+performance and safety of the device are supported by suitable evidence. Except for low-risk medical devices (Class I), where the manufacturer can self-assess the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility or metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market. A notified body would typically audit and examine a product’s technical dossiers and the manufacturer's quality system (notified body must presume that quality systems which implement the relevant harmonized standards – which is ISO 13485:2016 for Medical Devices Quality Management Systems – conform to these requirements). If satisfied that the relevant product conforms to the general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EU. 
+Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements. In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s). 
+The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to the European Database for Medical Devices (“EUDAMED”), unless they have already registered. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database. These new requirements aim at ensuring better identification and traceability of the devices. Each device – and as applicable, each package – will have a UDI composed of two parts: a device identifier (UDI-DI) specific to a device, and a production identifier (UDI-PI) to identify the unit producing the device. Manufacturers are also notably responsible for entering the necessary data on EUDAMED, which includes the UDI database, and for keeping it up to date. Certain obligations for registration in EUDAMED are expected to become applicable in the first quarter of 2026 (as EUDAMED is not yet fully functional). Until EUDAMED is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators. 
+All manufacturers placing medical devices into the market in the EU must comply with the EU medical device vigilance system which has been reinforced by the EU Medical Devices Regulation. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through EUDAMED – once functional – and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors such as the economic operators in the supply chain will also be informed. Until EUDAMED is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to apply. Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce the risk of a serious incident associated with the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration in the characteristics or performance of a device on the market (e.g., inadequacy in the information supplied by the manufacturer, undesirable side-effect), which, directly or indirectly, might lead to either the death or serious deterioration of the health of a patient, user, or other persons, or to a serious public health threat. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports. 
+The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the EU Medical Devices Regulation, only devices that are CE marked may be marketed and advertised in the EU in accordance with their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, for example, requiring that advertisements are evidenced, balanced and not misleading. Specific requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals. 
+Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the U.S., on medical device manufacturers. Certain countries also mandate implementation of commercial compliance programs. The aforementioned EU rules are generally applicable in the EEA. 
+In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with regulatory 
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+requirements (as applicable) could require time and resources to respond to the regulatory authorities' observations and to implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement powers and if such issues cannot be resolved to their satisfaction, they can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties. 
+Brexit and Regulation of Medical Devices in the United Kingdom 
+Since the end of the Brexit transition period on January 1, 2021, Great Britain (England, Scotland and Wales) has not been directly subject to EU laws, however under the terms of the Protocol on Ireland/Northern Ireland, EU laws generally apply to Northern Ireland. 
+The EU laws that have been transposed into UK law through secondary legislation remain applicable in Great Britain, however, new legislation such as the EU Medical Devices Regulation is not applicable in Great Britain. 
+The UK government has passed the Medicines and Medical Devices Act 2021, which introduced delegated powers in favor of the Secretary of State or an ‘appropriate authority’ to amend or supplement existing regulations in the area of medicinal products and medical devices. This allows new rules to be introduced in the future by way of secondary legislation, which aims to allow flexibility in addressing regulatory gaps and future changes in the fields of human medicines, clinical trials and medical devices. 
+The EU-UK Trade and Cooperation Agreement (“TCA”) came into effect on January 1, 2021. The TCA does not specifically refer to medical devices but does provide for cooperation and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and measures, standardization related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For medical devices that are locally manufactured but use components from other countries, the “rules of origin” criteria will need to be reviewed. 
+Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has become the sovereign regulatory authority responsible for Great Britain. New regulations require all medical devices to be registered with the MHRA, and since January 1, 2022, manufacturers based outside the UK have been required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA. 
+Furthermore, on December 16, 2024, the UK government published an amendment to the Medical Devices Regulations 2002 (UK Medical Devices Regulations) to clarify and strengthen the post-market surveillance requirements for medical devices in Great Britain. This amendment will come into force on June 16, 2025, and aims to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients. In addition, the MHRA launched a consultation between November 14, 2024 and January 5, 2025 on proposals to update the pre-market requirements for medical devices in Great Britain, covering four topics, namely: (1) a new international reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country; (2) the new UKCA mark and, in particular, proposals to remove the requirement to place such UKCA marking on devices; (3) conformity assessment procedures for in vitro diagnostic devices; and (4) maintaining in UK law certain pieces of “assimilated” EU law which are due to sunset in 2025. This consultation builds on the MHRA’s previous consultation between September and November 2021, and the UK government’s response to that consultation which was published on June 26, 2022. The MHRA has stated that it will incorporate feedback to its recent consultation into new legislation on pre-market requirements for medical devices in Great Britain. The new legislation is expected to be implemented in 2026 and aims to enable greater international collaboration and practices, with more patient-centered, proportionate requirements for medical devices which are responsive to technological advances. 
+Under the UK Medical Devices Regulations, in order to be lawfully placed on the Great Britain market, class I (non-sterile, non-measuring or non-re-useable) medical devices need to be “UKCA” self-certified, and other medical devices need to be “UKCA” certified by a UK approved body. However, certain medical devices in compliance with: (1) the EU Medical Devices Directive can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2028; or (2) the EU Medical Devices Regulation can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030. 
+Under the terms of the Ireland/Northern Ireland Protocol, Northern Ireland follows EU rules on medical devices, including the EU Medical Devices Regulation, and medical devices marketed in Northern Ireland require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing the device on the market in Northern Ireland. Alternatively, if a UK approved body conducts such assessment, a ‘UKNI’ mark and a CE mark are applied and the device may only be placed on the market in Northern Ireland and not the EU. 
+Other Foreign Regulations 
+Similarly, we are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of: 
+• design, development, manufacturing, and testing; 
+• product standards; 
+• product safety; 
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+• product safety reporting; 
+• marketing, sales, and distribution; 
+• packaging and storage requirements; 
+• labeling requirements; 
+• content and language of instructions for use; 
+• record keeping procedures; 
+• advertising and promotion; 
+• recalls and field corrective actions; 
+• import and export restrictions; and 
+• tariff regulations, duties, and tax requirements; 
+We may also become subject to the following additional requirements in many foreign countries in which we may sell future medical devices, including in the areas of: 
+• clinical testing; 
+• post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; 
+• registration for reimbursement; and 
+• necessity of testing performed in country by distributors for licensees. 
+Other Healthcare Laws and Regulations 
+Coverage and Reimbursement 
+Sales of any product that we may develop and for which we may obtain marketing authorization or certification from the FDA and/or comparable foreign regulatory authorities or notified bodies depend, in part, on the extent to which such product or services associated with such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product or services associated with such product by third-party payors. Even though a new product may have been cleared or otherwise authorized, or certified for commercial distribution by the FDA, foreign regulatory authorities or notified bodies, we may find limited demand for the product unless and until reimbursement approval has been obtained from governmental and private third-party payors. 
+With respect to Dream Sock and Dream Sight, we utilize a direct-to-consumer model where consumers purchase our products directly from us or one of our retailers. Currently, these products are not covered or reimbursed by any third-party payor. 
+Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical devices and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover the product or the services associated with the product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales. 
+Healthcare Fraud and Abuse 
+Federal and state governmental agencies and equivalent foreign authorities subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. These laws constrain the sales, marketing and other promotional activities of medical device manufacturers by limiting the kinds of financial arrangements we may have with hospitals, physicians and other potential purchasers and prescribers of our products. Federal healthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursable under Medicare, Medicaid, or other federally funded healthcare programs. The laws that may affect our ability to operate include: 
+• the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, arrangement for, or recommendation of, items or services for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value, and the government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of, or a specific intent to violate, the law; 
+15 
+• the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds; knowingly making, using, or causing to be made or used, a false record or statement to get a false claim paid or to avoid, decrease, or conceal an obligation to pay money to the federal government. A claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Actions under the False Claims Act may be brought by the government or as a qui tam action by a private individual in the name of the government and to share in any monetary recovery. There are also criminal penalties for making or presenting a false or fictitious or fraudulent claim to the federal government; 
+• the federal Health Insurance Portability and Accountability Act of 1996, which imposes criminal and civil liability for, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up a material fact or making a materially false, fictitious, or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items, or services; 
+• the federal Civil Monetary Penalties law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; 
+• the federal Physician Payment Sunshine Act, implemented by the Centers for Medicare & Medicaid Services (“CMS”) as the Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS, information related to payments and other “transfers of value” made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (including physician assistants and nurse practitioners), and teaching hospitals, and requires applicable manufacturers to report annually to CMS ownership and investment interests held by physicians and their immediate family members and payments or other “transfers of value” to such physician owners; 
+• analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers and patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state beneficiary inducement laws, and state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. 
+Violations of any of the above laws may result in significant administrative, civil and criminal penalties, including imprisonment, exclusion from participation in federal health care programs, such as Medicare and Medicaid, significant fines, monetary penalties and damages, the restructuring or curtailment of our operations, imposition of compliance obligations and monitoring, and reputational harm. 
+Data Privacy and Security Laws 
+Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing. 
+Anti-Bribery and Corruption Laws 
+We may also be subject to similar anti-corruption legislation implemented in Europe through EU Member State laws and under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions. 
+Intellectual Property 
+16 
+Since inception, we have been methodical around our intellectual property strategy. We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights. As of February 27, 2026, we had 63 issued patents (with numerous others pending) and 61 registered trademarks. Our patents include utility patents covering technology ranging from placement of electrodes to the base of the baby monitor. We have foreign patents and patent applications pending in the European region (including the EU and the United Kingdom), Australia, Brazil, Canada, China, India, Mexico, South Africa, Thailand, and Vietnam. Our issued patents with claims generally directed to wireless infant monitoring and related sock-based sensor features are expected to expire in the U.S. and certain international jurisdictions in 2033. Our issued patents with claims generally directed to additional sensing, monitoring, and related technologies have expiration dates extending into the late 2030s and early 2040s. In addition, our pending applications, if issued, would be expected to have expiration dates that extend into the 2040s and beyond (including, for certain granted rights, into 2051). We continually review our development efforts to assess the scope and patentability of new intellectual property. 
+Our pending patent applications may not result in issued patents, and we cannot assure you that any current or subsequently issued patents will protect our intellectual property rights. Third parties may challenge certain patents issued to us as invalid, may independently develop similar or competing technologies or may design around any of our patents. We cannot be certain that any of the steps we have taken will prevent the misappropriation of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights in these countries as fully as in the U.S. 
+Manufacturing 
+We rely on several third-party suppliers for single source components used in our devices, including the WiFi chips, microcontrollers, batteries, accelerometers, temperature sensors, plastics and circuit boards. 
+We follow strict quality guidelines, including a detailed risk-based audit plan following our ISO certified quality management system that dictates how often and to what degree we audit our suppliers. We check all quality, regulatory, and safety standards for products that our contract manufacturers make. We deploy a robust manufacturer and supplier selection process including site audits, tooling design and setup quotes, open book pricing, quality specifications, and vendor guides. Dream Sock is currently manufactured at ISO 13485 certified standards and are required to adhere to specific quality requirements in accordance with the International Medical Device Regulators Forum (IMDRF) and Medical Device Single Audit Program (MDSAP). We received ISO 13485 and MDSAP certifications, as we work to implement and maintain the requirements applicable to medical device manufacturer quality management systems. We believe that third-party facilities are adequate to meet our current and anticipated manufacturing needs, and we utilize multiple sites in different geographies to diversify political and natural disaster risks. We do not currently plan to manufacture our products or any related components ourselves. 
+Manufacturing Services Agreement with Benchmark Electronics 
+In October 2017, we entered into a manufacturing services agreement with Benchmark Electronics, Inc. (“Benchmark”), pursuant to which Benchmark provides us certain manufacturing and related services for the production of Dream Sock, BabySat, and Dream Duo offerings out of its facilities in Thailand, including procuring materials and assembling and testing finished products. In 2026 we plan to expand our manufacturing partnership with Benchmark at a new site in Mexico. 
+The initial term of the agreement was one year and automatically extends for additional one-year periods until either we or Benchmark provide notice of non-renewal at least 90 days prior to the end of the then-current term or extension. Among other things, either party may terminate the agreement for convenience upon 90-day notice, in the case of Owlet, or 180 day notice, in the case of Benchmark, to the other party. Either party may also terminate the agreement under certain other customary conditions, including if the other party materially breaches the agreement, for uncured breaches of the agreement, or in the event of the other party’s insolvency. Benchmark has exclusive manufacturing rights through May 31, 2027, for Dream Sock and Dream Duo products, including all revisions and future generations of those products and/or product families. 
+In connection with the services provided under the agreement, we have agreed to indemnify Benchmark against certain claims, including infringement of third-party intellectual property rights and noncompliance of our products with safety or other regulations. We are also entitled to customary indemnification rights, subject to certain caps. 
+Manufacturing Services Agreement with Aoni 
+In June 2018, we entered into a manufacturing and supply agreement with Shenzhen Aoni Electronic Co., Ltd (“Aoni”), pursuant to which Aoni provides certain manufacturing and related services for the production of our Dream Sight product, including procuring materials and assembling and packaging finished products. We manufacture product with Aoni at sites in China and Vietnam. Dream Sight product sold in Europe and Asia-Pacific countries is manufactured in China, while product sold in North America is manufactured in Vietnam. 
+We have extended the term of the agreement several times following the expiration of the initial term of the agreement, and most recently extended the term through June 2026. We have the right to terminate the agreement, without cause, upon six months’ prior 
+17 
+written notice to Aoni. Additionally, either party may terminate the agreement under certain other customary conditions, including for uncured breaches of the agreement or in the event of the other party’s insolvency. 
+In connection with the services provided under the agreement, Aoni has agreed to indemnify us against certain claims and liabilities, including claims arising in connection with product defects, breach of the agreement, negligence and violations of applicable law. 
+Technology Platform & Infrastructure 
+Our digital ecosystem is built on a scalable, secure, and hybrid technology platform designed to support millions of connected devices and process vast amounts of health and sleep data in real-time. We utilize a combination of third-party Internet of Things (IoT) connectivity providers and our own proprietary cloud infrastructure, hosted primarily on Google Cloud Platform (GCP) and some on Amazon Web Services (AWS) to ensure high availability and redundancy. 
+This platform supports the core functionality of our Owlet Dream App, BabySat and Dream Sock, enabling parents to monitor their children, receive real-time health notifications, and access historical sleep insights, in addition to viewing live video streams. We are actively investing in the modernization of our backend architecture to enhance data integration capabilities and support advanced analytics. This infrastructure serves as the foundation for our research and development initiatives, allowing us to leverage proprietary algorithms and artificial intelligence to derive meaningful insights from our proprietary data set of infant health and sleep. 
+Security and data privacy are central to our technology strategy. We implement rigorous cybersecurity protocols to protect user data and maintain the integrity of our connected ecosystem. We continuously validate our security posture through internal reviews and external certifications, such as the SGS Cybersecurity Mark, to ensure compliance with evolving global data protection standards. 
+Environmental Matters 
+Our operations, properties and products are subject to a variety of U.S. and foreign environmental laws and regulations governing, among other things, air emissions, wastewater discharges, management and disposal of hazardous and non-hazardous materials and waste and remediation of releases of hazardous materials. We believe, based on current information, that we are in material compliance with environmental laws and regulations applicable to us. However, our failure to comply with present and future requirements under these laws and regulations, or environmental contamination or releases of hazardous materials on our leased premises, as well as through disposal of our products, could cause us to incur substantial costs, including clean-up costs, personal injury and property damage claims, fines and penalties, costs to redesign our products or upgrade our facilities and legal costs, or require us to curtail our operations, any of which could seriously harm our business. 
+Human Capital Resources 
+As of December 31, 2025, we had 108 full-time employees and 6 part-time employees. None of our employees is represented by a labor union, and we consider our employee relations to be good. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors, through the granting of stock-based compensation awards and cash-based performance bonus awards. 
+We believe our innovation and operational excellence stems directly from our community and our common commitment to inclusion and equal access to healthcare. One cornerstone of our approach lies in our belief that every baby deserves access to monitoring, regardless of their background or circumstances. Through Owlet Cares, our advocacy initiative, we are dedicated to making a positive impact in the lives of babies and parents. We recognize that parenthood is a journey marked by a range of experiences, challenges, and joys. As such, we are dedicated to supporting all parents from a rich tapestry of backgrounds and perspectives. 
+Corporate Information 
+Owlet Baby Care Inc. was incorporated in Delaware on February 24, 2014, as a Delaware corporation. SBG was incorporated in Delaware on June 23, 2020. On July 15, 2021, SBG closed the Merger with Owlet Baby Care Inc. As a result of the Merger, Owlet Baby Care, Inc. became a wholly-owned subsidiary of SBG, and SBG changed its name to Owlet, Inc. 
+Available Information 
+Our website address is www.owletcare.com. The contents of, or information accessible through, our website are not part of this Report. We make our filings with the SEC, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, as well as beneficial ownership filings available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish such reports to, the SEC. 
+We may use our website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at https://investors.owletcare.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address under the “Resources” menu on the Investors section of our website at https://investors.owletcare.com. 
+18 
+The reference to our website address does not constitute incorporation by reference of the information contained on or available through our website, and you should not consider such information to be a part of this Annual Report on Form 10-K.

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raw/filings/0001816736/2025/0001193125-26-073602/item13.txt

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+Item 13. 
+Certain Relationships and Related Transactions, and Director Independence 
+145

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+Item
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raw/filings/0001817004/2025/0001493152-26-016896/item13.txt

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+Item
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+Item 1. Bu siness. 
+Overview 
+Vor Bio is a clinical-stage company harnessing the power of cell and genome engineering to develop potentially transformative therapies in acute myeloid leukemia (“AML”), a devastating disease with few treatment options. AML is the most common type of acute leukemia in adults and one of the deadliest and most aggressive blood cancers, affecting approximately 20,000 newly diagnosed patients each year in the United States. 
+The traditional tumor targeting approach to treating blood cancers such as AML focuses on cancer cells expressing a target antigen. However, very few targets are tumor-specific, as healthy cells usually express these same target antigens alongside cancer cells. While technologies may improve the specificity of target antigen binding or enhance potency, these approaches are subject to the same fundamental biological limitation of killing healthy cells expressing these targets, known as on-target toxicity. A number of targeted therapies have failed in clinical development, and those that have succeeded possess limited utility and narrow applicability, in part due to their on-target toxicity. Hematopoietic cell transplant (“HCT”) is the standard of care for AML, replacing cancerous marrow with cells from a matched healthy donor. Unfortunately, approximately 40% of patients with AML who receive a HCT suffer a relapse of their leukemia and have two-year survival rates of less than 20%. Transplanted hematopoietic stem cells (“HSCs”) are fragile following transplant, preventing the use of potentially curative treatment options. 
+Vor Bio’s proprietary platform aims to change the entire paradigm of AML treatments by genetically engineering healthy donor cells to remove therapeutic targets, thereby creating patients’ bone marrow and blood systems that are shielded from on-target toxicities from targeted therapies. Vor Bio is also developing chimeric antigen receptor (“CAR”)-T cell therapies to kill cancer, uniquely deriving these treatments from the same healthy transplant donor used to create the shielded transplant. Vor Bio's vision is to couple targeted therapies such as antibody drug conjugates ("ADCs") or our own CAR-T therapies with shielded HSC transplants. We believe that this therapeutic approach of shielded HSC transplants followed by targeted therapies, what we call our Treatment System, has the potential to cure AML beyond existing therapeutic options. 
+The Vor Bio Platform 
+We have built a technology platform to realize our vision that allows for selective cancer targeting with highly potent targeted therapies by leveraging our expertise and recent advances in stem cell biology and genome engineering. Our approach is in stark contrast to conventional approaches that have focused solely on developing the therapeutic and have faced clinical limitations due to toxicities. The key components of our proprietary platform are stem cell biology and manufacturing expertise, genome engineering to HSCs and unlocking the potential of targeted therapies . 
+• 
+Leveraging Stem Cell Biology and Manufacturing Expertise. We have built an extensive understanding of the biology of HSCs to enable our shielded transplants to retain their cellular viability and functionality during manipulation. In addition, we have built process development expertise centered around HSCs, enabling us to process these cells quickly, precisely, reproducibly and efficiently for patients. We are continuing to develop our in-house clinical GMP manufacturing capabilities and facilities to further allow us to leverage our expertise and maintain strategic control over the manufacturing process. 
+• 
+Applying Genome Engineering to Hematopoietic Stem Cells. Recent developments in genome engineering allow permanent changes to DNA in cells and all their progeny. We have assembled a team with extensive experience in applying genome engineering technologies to HSCs, which display distinct DNA repair mechanisms compared to many other cell types. We possess expertise in a variety of genome engineering technologies including CRISPR-Cas9, CRISPR analog enzymes and base editing, 
+5 
+and we are capable of multiplex editing using a variety of techniques, all with the objective of creating various shielded transplants. 
+• 
+Unlocking the Potential of Targeted Therapies. We believe our shielded transplants are a potential solution to the lack of tumor-specific targets and can enable selective cancer targeting with a variety of modalities including ADCs and our own CAR-T therapies. We are directly developing CAR-T therapies, which we believe are the most potent form of targeted therapies available. Our CAR-T product candidates are uniquely generated from prior healthy transplant donors where these cells are healthy, more stemlike compared to other cell sources and exactly matched to the patient since the patient’s blood and immune system was previously reconstituted by the transplant donor. Our objective is to create highly potent CAR-T therapies that are designed to strongly proliferate and persist in patients, in order to drive prolonged relapse-free survival or induce cures in patients, and could be used following a trem-cel transplant either alone or in combination with an ADC. 
+Advantages of Our Shielded Transplant Technology and Manufacturing Process 
+Our shielded transplant technology and manufacturing process is designed to confer advantages and address limitations associated with existing cell therapy processes. 
+• 
+Speed—Rapid manufacturing cycle and vein-to-vein time. In contrast to other patient-specific cell therapies, such as CAR-T therapies and gene-modified allogeneic cell therapies, the manufacturing of our shielded transplant is a rapid and elegant process that fits into the standard HSC transplant process. The primary reason we can produce a shielded transplant so quickly is the lack of a need for cell expansion. Our approach to creating eHSCs also does not involve the insertion of new genetic material, thereby avoiding complications related to the use of delivery modalities necessary for gene insertion, such as the viral vectors used in CAR-T therapies. The relatively simple and streamlined process of creating our shielded transplant provides significant advantages in the required manufacturing infrastructure. We believe the efficiency and low capital expenditure of our manufacturing process should translate into higher scalability, a lower cost of goods and easy integration into routine transplant practice. 
+• 
+Investment in our internal manufacturing facility. We operate an in-house clinical manufacturing facility in Cambridge, Massachusetts to support the development of our potentially transformative product candidates for patients with blood cancers. The facility provides us with end-to-end oversight over drug product for our planned clinical trials. Our manufacturing teams are seamlessly integrated within our wider organization, a crucial component of our strategy as we continue to enroll our clinical studies. The facility has been designed to support clinical manufacturing for CAR-T therapeutic candidates and to be cGMP compliant. By integrating our internal research, process development, analytical development, manufacturing and quality control testing capabilities under one roof, we aim to achieve flexible manufacturing capacity and to reduce the time and cost required to manufacture complex cell therapy clinical product candidates. 
+Our Clinical Development Programs & Pipeline 
+Tremtelectogene empogeditemcel (trem-cel) 
+Trem-cel is a genome-edited hematopoietic stem and progenitor allogeneic donor product candidate where CD33 has been deleted using genome engineering. Transplant with trem-cel is designed to replace standard of care transplants for patients suffering from AML and other blood cancers. Trem-cel has the potential to enable powerful targeted therapies in the post-transplant setting including CD33-targeted CAR-T cells and ADCs. 
+Trem-cel has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) as a treatment to reduce the risk associated with gemtuzumab therapy for the treatment of high-risk AML following hematopoietic stem-cell transplantation, allowing for potential facilitated development and an expedited review process, and also received orphan drug designation (“ODD”) for the treatment of AML, which is granted by the FDA to a drug or biologic intended to treat a rare disease or condition that affects fewer than 200,000 individuals in 
+6 
+the United States. ODD entitles companies to development incentives including tax credits for clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity in the event of regulatory approval. 
+We are actively enrolling VBP101 (NCT04849910), a Phase 1/2a clinical trial for patients with CD33-positive AML or myelodysplastic syndrome (" MDS") who are at high risk of relapse. The primary goals of the trial are to evaluate tolerability and feasibility of the trem-cel transplant, with a focus on confirming that trem-cel can engraft normally. Following engraftment, patients are eligible to be treated with Mylotarg, a CD33-directed ADC therapy, in order to potentially prolong leukemia-free survival and provide evidence that trem-cel protects against the myelosuppression that typically accompanies treatment with Mylotarg. To administer trem-cel, HSCs from matched healthy donors are isolated, engineered into trem-cel and then introduced into patients following myeloablative conditioning. We expect that engraftment of trem-cel will occur within 28 days of administration, which occurs in over 90% of standard HCT procedures. As a safety measure, we freeze and preserve a portion of the original donor cells to use in case trem-cel fails to engraft. At day 60, we re-evaluate patients for disease status. Those patients with successful trem-cel grafts who experience relapse of their AML will then become eligible to be treated with therapeutic doses of Mylotarg. Other patients are treated with maintenance doses of Mylotarg once a month for four months to address any remaining minimal residual disease (“MRD”). 
+The latest data update from VBP101 was presented in a poster at the American Society of Hematology (ASH) Annual Meeting on December 8, 2024, which was also presented in an encore presentation at the TANDEM Meetings (Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR) on February 15, 2025. 
+The data released included 25 patients treated with trem-cel of which 15 had received Mylotarg (six at the 2 mg/m 2 dose) as of the data cut-off date of November 1, 2024. The data demonstrated: 
+• 
+Preliminary evidence of improved relapse-free survival (median RFS not reached with median follow-up duration of 7.4 months) compared to published groups of AML patients at high risk of relapse post hematopoietic stem cell transplant (HCT). 
+• 
+Shielding of the blood system, with maintained neutrophil and platelet counts across multiple serial Mylotarg doses of 0.5, 1, and 2 mg/m 2 . 
+• 
+Broadened therapeutic index for Mylotarg when administered after trem-cel. 
+• 
+Reliable engraftment, with 100% of patients achieving primary neutrophil engraftment (median 9.5 days), robust platelet recovery (median 16 days), and full myeloid donor chimerism at Day 28. 
+• 
+Trem-cel continues to be manufactured with high CD33 editing efficiency (median 90%, range 71-94%). 
+Patients are now being treated in this study at the recommended Phase 2 dose of Mylotarg at 2.0 mg/m 2 . Patients receiving a trem-cel transplant in VBP101 who become MRD-positive or relapse have the option to receive Mylotarg or VCAR33 (previously called VCAR33 ALLO ). 
+In December 2024, we met with the FDA regarding data from the trem-cel + Mylotarg study alongside a proposed registrational clinical trial synopsis. The FDA agreed that trem-cel engrafts neutrophils and platelets and has a similar safety profile to unedited CD34+ grafts. In addition, there was agreement on the trem-cel + Mylotarg registrational clinical trial design with respect to study population, control arm, primary endpoint, stratification factors, and statistical design. We agreed to provide further updates to the FDA alongside submission of the full clinical trial protocol. 
+We expect to report further engraftment and protection data from the VBP101 clinical trial in the second half of 2025. 
+Trem-cel and Myelodysplastic Syndrome 
+In 2024, the VBP101 protocol was amended to include patients with MDS and we are now enrolling MDS patients into the study. Scientific evidence produced by third parties shows that blast cells responsible for MDS 
+7 
+express CD33 and other myeloid cell surface targets. We believe trem-cel has the potential to provide a therapeutic window that enables anti-CD33 therapies to be effective in this setting. 
+VCAR33 
+VCAR33 is manufactured from lymphocytes collected from the patient’s original transplant donor, generating a CAR-T cell therapy that is exactly matched to the recipient’s engrafted blood system. By using healthy transplant donor cells as the starting material to produce VCAR33, the CAR-T cells have a more stem-like phenotype, leading to greater potential for expansion, persistence and anti-leukemia activity compared to a product derived from a patient’s own lymphocytes. 
+We are actively enrolling VBP301 (NCT05984199), a Phase 1/2, multicenter, open-label, first-in-human study of VCAR33 in patients with relapsed or refractory AML after standard-of-care transplant or a trem-cel transplant. In September 2024, we announced encouraging in vivo CAR-T expansion data from the first three patients treated in this study, all at the lowest dose of 1 x 10 6 CAR+ cells/kg. We anticipate sharing additional data from the study in the first half of 2025. 
+The trial is evaluating safety, as well as key outcome measures including incidence of graft-versus-host disease related to VCAR33, percentage of patients who achieve response and overall survival and progression-free survival post-VCAR33 infusion. The first phase, which is expected to enroll approximately 12 patients, is designed to determine the maximum tolerated dose of VCAR33 using a 3+3 trial design; the second phase, which is expected to enroll up to 12 patients, is an expansion phase designed to evaluate the rate of clinical response to treatment. The trial is designed to test the hypothesis that a CD33-targeted CAR-T derived from a healthy donor can be safely administered to a patient with AML who has relapsed after transplant and that the CAR-T can demonstrate anti-leukemia activity. 
+The FDA has granted Fast Track designation to VCAR33 for the treatment of relapsed/refractory AML after allogeneic hematopoietic stem-cell transplantation and ODD for the treatment of AML. 
+We licensed VCAR33 from the U.S. Department of Health and Human Services, as represented by National Cancer Institute (“NCI”) of the National Institutes of Health (“NIH”). 
+Trem-cel+VCAR33 Treatment System 
+We believe that the combination of a trem-cel transplant followed by VCAR33, our in-house CD33-directed CAR-T program, which we refer to as the trem-cel+VCAR33 Treatment System, in the maintenance setting has the potential to transform patient outcomes in AML and establish a new standard of care for patients with high risk of relapse. 
+The trem-cel+VCAR33 Treatment System would utilize cells from the same healthy donor for both trem-cel and VCAR33. In this scenario, the apheresis product from the healthy donor would be processed to serve as starting materials for both products. One advantage of this approach is that donor-derived T cells should not recognize CAR-T cells as foreign, potentially prolonging persistence and optimizing CAR-T expansion. In addition, sourcing T cells from healthy donors may provide a healthier, more abundant cell source, allowing for optimizations and efficiencies in the manufacturing process that are not possible with autologous sources. Unlike autologous CAR-T therapies, the manufacturing of the CAR-T cells would not be rate limiting when combined with trem-cel, as we expect the CAR-T therapy would not be needed until 60 days after administration of trem-cel. 
+Patients who have relapsed after a trem-cel transplant are also eligible to enroll in the VBP301 protocol and to receive VCAR33. The ability to treat relapsed trem-cel transplant patients with VCAR33 may provide valuable early insights into the potential of the trem-cel+VCAR33 Treatment System. 
+We anticipate initiating a Phase 1 clinical trial with the trem-cel+VCAR33 Treatment System in the second half of 2025. 
+8 
+VADC45 
+In September 2024, we announced a new preclinical asset, VADC45, which has multiple potential opportunities in oncology, gene therapy, and autoimmune disorders. VADC45 is an ADC that targets the CD45 protein. CD45 is a well-validated target for a wide variety of blood cancers with clinical proof of concept. The linker-payload used in VADC45 is also clinically validated. 
+VADC45 has the potential to treat several diseases, including treatment of hematologic malignancies, as a targeted conditioning agent for gene therapies such as for sickle cell disease, holistic immune reset for autoimmune disorders, and for our approach of combining this asset with epitope modification of CD45 to shield healthy stem cells. We already have robust preclinical data for VADC45 and are progressing IND-enabling studies to enable future Phase 1 studies. 
+Ongoing Preclinical Programs 
+We believe our approach can extend beyond CD33 where protein targets fulfill three important criteria: first, the targets are expressed on cancer cells; second, the targets are expressed on cells of hematopoietic lineage (and therefore present a safety concern); and last, there is evidence that the targets are biologically dispensable. We have generated preclinical data exploring targets such as CD123, EMR2 and CD5, which all currently show promise fulfilling these criteria. 
+Other Myeloid Targets: CD123, CLL-1 and EMR2 
+CD123, CLL-1 and EMR2 are targets expressed strongly in various myeloid blood cancers including AML. These targets are expressed both in bulk AML cells as well as leukemic stem cells. Our preclinical data demonstrates our ability to genetically engineer HSCs in human cells to remove expression of these targets with good efficiency. As such, we continue to research these targets as potential target candidates for our shielded transplants and CAR-T therapies. 
+Our Multiplex Engineering Strategy 
+Multiplex engineering is a strategy and method where multiple genetic targets are engineered within the same cells in the same manufacturing process. Multiplex engineering could allow removal or modification of two or more distinct genes, thus allowing for targeted therapies directed at two or more separate targets to be used in combination or in sequence. 
+A multiplex approach may provide advantages in two areas. First, target expression can vary in tumor cells from the same patient, a phenomenon known as tumor antigen heterogeneity. Applying therapies such as a multi-target-specific CAR-T may reduce that concern. Second, it is possible for tumor cells to downregulate expression of a target to avoid being killed, known as tumor antigen escape. Again, pursuing multiple targets simultaneously may reduce the effectiveness of the tumor escape mechanism. 
+To mitigate these problems, we are developing multi-target-specific CAR-T cells to attack multiple antigens on the surface of AML blasts. As these target antigens are also expressed on the surface of normal myeloid cells, we need to develop a transplant solution where the normal hematopoietic compartment is shielded from such immuno-therapy assault. To do so, we need to delete or modify the target antigens from the hematopoietic stem and progenitor cells in order to render protection to the nascent graft. 
+We have developed several techniques for multiplex engineering HSCs. One such technique is sequential Cas9 editing, where HSCs are subject to two separate Cas9 edits separated by a defined time period in order to allow the first edit to complete before applying the second edit. This separation is important to avoid chromosomal translocations, which are gene repairs resulting in one DNA segment joining other DNA segments from different parts of the same chromosome or segments of other chromosomes. We have demonstrated that we can efficiently knock out expression of both CD33 and CLL-1 from HSCs using this technique. 
+9 
+Another technique involves a technology called base editing, which involves converting a specific DNA base into another at a targeted genomic locus. As such, base editing does not require a DNA double-strand break, lowering the risk of translocation. We have demonstrated that we can efficiently knock out expression of both CD33 and CLL-1 from HSCs using a single base editing step. 
+CD33-CLL1 Treatment System 
+Leveraging our platform, we are advancing the creation and preclinical testing of multiplex-engineered HSCs, in which multiple surface targets are removed, potentially obviating concern around tumor heterogeneity and potential escape mechanisms. 
+We are pursuing our first multi-targeted CD33-CLL1 Treatment System comprising a CD33-CLL1 multiplex-edited HSC therapy and a CD33-CLL1 multi-specific CAR-T therapy. These next-generation, multiplex-edited HSCs may enable a wide range of treatment options post-transplant, including the use of multi-specific CAR-T therapies. Our dual-specific CAR-T uses the potency of two targets to address the large unmet need of patients with relapsed/refractory AML. 
+In a proof-of-concept study, we have demonstrated that CD33/CLL-1 dual deleted cells survive the attack from CD33/CLL-1 dual CAR-T cells, whereas wild-type or single deleted cells die when targeted by multi-CAR-T cells. 
+IND-enabling work is progressing for the CD33-CLL1 dual-specific CAR-T with key in vivo proof-of-concept experiments underway. 
+Commercial Strategy and Reimbursement Framework for Our Shielded Transplants and CAR-T Product Candidate 
+Given the potential value proposition of shielded transplants enabling targeted therapies, our goal is to maximize the reach of our therapies, if approved, to all patients in the transplant setting suffering from blood cancers. Each year, approximately 42,500 new cases of AML are diagnosed across the United States (approximately 20,000), Europe (approximately 18,000) and Japan (approximately 4,500). For the past 20 years, there has been an increasing trend in allogeneic transplants for AML. Currently, there are approximately 12,000 allogeneic HCTs performed globally each year, with approximately 3,500 performed in the United States, 7,000 in Europe and 1,500 in Japan. 
+We believe we will be able to commercialize our shielded transplants and targeted therapies, if approved, with a focused footprint where we can leverage the existing logistical infrastructure of NMDP and HSC transplants centers. HCTs are performed at tertiary medical care hospitals with specialized HSC transplant centers. The United States, EU5 and Japan have approximately 200, 300 and 185 transplant centers, respectively. The transplant volumes are further concentrated with 15% transplant centers performing 50% of U.S. transplants. Building on a concentrated network of transplant centers, we have the added advantage of an approximately seven-day manufacturing process. This turn-around time for collecting cells and shipping is a critical component of successful commercialization. 
+We believe multiple reimbursement pathways may be available in the United States to capture the value of shielded transplants and targeted therapies, such as CAR-T. Effective for cost reporting periods beginning on or after October 1, 2020, under the Hospital Inpatient Prospective Payment System (“IPPS”), Medicare payment for HCT will include a carve-out for the actual cost of stem cell acquisition and processing, and payment will instead be made on a reasonable cost basis. We believe this new rule may apply to innovative sources of donor stem cells like eHSCs. In addition, the Medicare Severity Diagnosis-Related Group (“MS-DRG”) establishes a base payment rate of approximately $258,000 for CAR-T cases. 
+A potential alternative reimbursement pathway for shielded transplants is Medicare New Technology Add-on Payment (“NTAP”) which, if approved, allows for temporary reimbursement for new cell therapies above the standard MS-DRG payment threshold. When certain criteria are met, the Centers for Medicare & Medicaid Services (“CMS”), the federal agency responsible for administering the Medicare program, may provide incremental 
+10 
+reimbursement for up to 65% of the cost of therapy in addition to the standard MS-DRG payment. For patients covered by commercial insurance, we believe that reimbursement will be based on a case rate methodology with provisions for separate payments for new therapies such as shielded transplants. Lastly, risk-sharing agreements or value-based purchasing models is another option that is becoming more common with novel cell and gene therapies. 
+Sales and Marketing 
+Given our stage of development, we have not yet established a commercial organization or distribution capabilities. We plan to build focused capabilities in the United States to commercialize our development programs focused on shielded transplants and targeted therapies. We plan to focus our efforts in the United States because we believe the patient populations and medical specialists for the indications we are targeting are sufficiently concentrated to allow us to effectively promote our products, if approved for commercial sale, with a targeted sales team. In other markets for which commercialization may be less capital efficient because the patient populations and medical specialists are less concentrated, we may selectively pursue strategic collaborations with third parties in order to maximize the commercial potential of our product candidates. 
+License Agreements 
+Exclusive License Agreement with Columbia University 
+In April 2016, we entered into an exclusive license agreement with The Trustees of Columbia University in the City of New York (“Columbia”), which agreement was subsequently amended in February 2019 and November 2021 (the “Columbia Agreement”). Pursuant to the Columbia Agreement, we obtained a worldwide, exclusive license, with the right to grant sublicenses (subject to certain restrictions), under certain of Columbia’s patents, know-how and materials to discover, develop, manufacture, have made, use, sell, offer to sell, have sold, import, export, distribute, rent or lease products that are covered by such patents or involve the use of or otherwise incorporate such know-how or materials, in each case for any and all uses, related to the inhibition of lineage-specific antigens, including related to eHSCs. The foregoing license is subject to certain customary retained rights of Columbia, including the right to conduct academic research and publish know-how. We are also obligated to use commercially reasonable efforts to research, discover, develop and market licensed products for commercial sale and distribution, including by achieving one or more specified diligence milestones. 
+We are obligated to pay Columbia royalties on net sales of products that are covered by the licensed patents on a patented product-by-patented product basis and country-by-country basis for such period as a valid claim covers such patented product in such country, which we expect to be until January 2040, absent any applicable patent term extensions, and, on an unpatented product-by-unpatented product and country-by-country basis for the longer of ten years from first commercial sale of such unpatented product in such country or expiration of any market exclusivity for such unpatented product in such country. If the royalty term for a patented product expires in a country and such product would otherwise qualify as an unpatented product in such country (and the applicable royalty term for such unpatented product has yet to expire in such country), then we are obligated to pay Columbia royalties for such unpatented product for the remainder of the royalty term in such country. 
+The Columbia Agreement expires on a country-by-country and product-by-product basis upon expiration of the applicable royalty term for such product in such country. Columbia may either terminate the Columbia Agreement or convert our license to a non-exclusive license in the case of our insolvency, or upon our uncured material breach of the agreement of certain specified provisions, including in the event that we fail to achieve one or more specified diligence milestone(s) and fail to mutually agree upon a revised plan for development of a licensed product. Additionally, we have the right to terminate the Columbia Agreement at any time upon specified written notice to Columbia. 
+Exclusive License Agreement with National Institutes of Health 
+In October 2020, we entered into a patent license agreement (the “Patent License”) with the U.S. Department of Health and Human Services, as represented by National Cancer Institute (“NCI”) of the NIH. Pursuant to the 
+11 
+Patent License, we hold an exclusive, worldwide license, sublicensable with the prior written consent of NIH, to certain intellectual property rights to develop, manufacture and commercialize licensed products, or to practice licensed processes, in each case, for use in the development of a CAR therapy mono-specific for CD33 for the prophylaxis or treatment of CD33-expressing hematological malignancies (but excluding CD33-specific logic-gated CAR-based immunotherapies) wherein the CAR is comprised of the CD33-binding domain referenced as Hu195 or hP67.6, is delivered via lentiviral transduction, and the T cells are derived from the patient or from an allogeneic source, which we collectively refer to as the field of use. 
+We must pay NCI tiered royalties on net sales of licensed products on a licensed product-by-licensed product and country-by-country basis, commencing on the date of first commercial sale of such licensed product in such country, until the date such licensed product ceases to be covered by a valid claim of a licensed patent in such country, which we expect to occur in March 2039, absent any applicable patent term extensions, and are subject to reduction for unblocking licenses from third parties, subject to a specified royalty floor. 
+The Patent License will expire upon expiration of the last valid claim of a licensed patent, unless terminated earlier as described below. NCI may terminate the Patent License in the event of a material breach, including if we do not use reasonable commercial efforts to execute the commercial development plan, or if we do not achieve the performance milestones by certain dates, following the expiration of a 90-day notice period during which we must ether cure the relevant breach or initiate corrective action to NCI’s reasonable satisfaction. We may terminate the Patent License, in its entirety or with respect to any license in any country, in our sole discretion at any time upon 60 days’ written notice to NCI. In addition, NCI has the right to require us to grant sublicenses under the licensed patent rights in any of the fields of use under specified conditions, if required by public health or safety concerns, or to terminate or modify the Patent License if deemed necessary to meet requirements for public use as specified by federal regulations, if NCI determines that we are not reasonably satisfying such requirements. 
+Worldwide non-exclusive license to Cas9 gene-edited HSCs from Editas Medicine, Inc. 
+In August 2023, we entered into a worldwide non-exclusive license from Editas Medicine for ex-vivo Cas9 gene-edited HSC therapies for the treatment and/or prevention of hematological malignancies. The license provides access to key intellectual property for the continued development and commercialization of edited HSCs including trem-cel, with the option to elect additional product candidate targets within the next five years. 
+Competition 
+We face potential competition from various sources, including larger and better-funded pharmaceutical, specialty pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions, any of which may be more successful in developing or marketing products and technologies that are more effective, safer or less costly. These entities may also compete with us in hiring scientific and management personnel, establishing clinical study sites, recruiting patients to participate in clinical trials and acquiring technologies complementary to, or necessary for, our programs. 
+In the case of our lead shielded transplant product candidate, trem-cel, we are not aware of any approved products in development that apply gene engineering technology to donor HSCs to reduce the on-target toxicity of targeted cancer therapies. However, we face potential competition from multiple private and public HSC companies such as Beam Therapeutics, Inc., Cimeio Therapeutics, ExCellThera and Garuda Therapeutics. 
+In the case of VCAR33, there are several companies exploring CAR therapies in early trials for relapsed/refractory AML, including IN8Bio Inc., Senti Biosciences Inc., AvenCell Therapeutics, Inc., Arcellx inc., Caribou Biosciences, Inc., Cellectis S.A., Guangzhou Bio-gene Technology Co., Ltd, iCell Gene Therapeutics, LLC, Hangzhou Qihanjiyin Biotech Co., Ltd., and Suzhou Maximum Bio-tech Co., Ltd. 
+In addition, there are companies attempting to treat relapsed/refractory AML through other treatment modalities such as AbbVie, Inc., SystImmune, Inc., Hangzhou DAC Biotech., Ltd., Actinium Pharmaceuticals, Inc., Affirmed GmbH, and Aptevo Therapeutics, Inc., Bristol Myers Squibb, Inc., GT Biopharma, Inc., MacroGenics, 
+12 
+Inc., Molecular Partners AG, Sanofi S.A., Stemline Therapeutics, Inc., Trueline Therapeutics, Inc., Vincerx Pharma, Inc., and AstraZeneca, plc. 
+Beyond CAR-T therapies, a number of small molecule and monoclonal antibody products have been approved in recent years for the treatment of AML, including AbbVie Inc.’s Venclexta (venetoclax), Agios Pharmaceuticals Inc.’s Tibsovo (ivosidenib), Astella Pharma Inc.’s Xospata (gilteritinib), Bristol-Myers Squibb Company’s Idhifa (enasidenib), Vidaza (azacitidine), and Onureg (azacitidine), Daiichi Sankyo, Inc.’s Vanflyta (quizartinib), Jazz Pharmaceuticals plc’s Vyxeos (daunorubicin and cytarabine), Novartis International AG’s Rydapt (midostaurin), Pfizer Inc.’s Mylotarg (gemtuzumab ozogamicin) and Daurismo (glasdegib), Rigel Pharmaceuticals, Inc.’s Rezlidhia (olutasidenib), and Syndax Pharmaceuticals Inc.’s Revuforj (Revumenib). 
+Manufacturing 
+We operate an in-house clinical manufacturing facility in Cambridge, Massachusetts to support development of our therapeutic candidates for patients with blood cancers. The facility is located in the same premises as our headquarters, in Cambridge, MA. We have designed the facility to support clinical manufacturing for our cell therapy programs and to be cGMP compliant. By integrating our internal research, process development, analytical development, manufacturing, and quality control testing capabilities under one roof, we believe we can achieve flexible manufacturing capacity and reduce the time and cost required to manufacture our complex cell therapy clinical candidates. While this facility is fully operational, we continue to rely on third-party contract manufacturers for clinical manufacturing of trem-cel and our required raw materials, manufacturing devices, active pharmaceutical ingredients and finished product for our research and clinical manufacturing. We do not have long-term agreements with any of these third parties. We also do not have any current contractual relationship for the manufacture of material for clinical trials beyond Phase 1/2a or commercial supplies. We intend to enter into agreements with third-party contract manufacturers and one or more backup manufacturers for future production. Although we are developing certain in-house manufacturing capabilities for our current clinical needs, we continue to analyze the feasibility of building additional manufacturing capabilities for future development and commercial quantities of any products that we develop. Such products will need to be manufactured in facilities, and by processes, that comply with the requirements of the FDA and the regulatory authorities of other jurisdictions in which we are seeking approval. 
+Intellectual Property 
+Overview 
+We strive to protect the proprietary product candidates and technologies that we believe are important to our business, including seeking and maintaining patent protection intended to cover the composition of matter of our product candidates, their methods of use, their methods of production, related technologies, and other inventions. In addition to patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection, including certain aspects of technical know-how. 
+Our commercial success depends in part upon our ability to obtain and maintain patent and other proprietary protection for commercially important technologies, inventions and know-how related to our business, defend, and enforce our intellectual property rights, particularly our patent rights, preserve the confidentiality of our trade secrets and operate without infringing valid and enforceable intellectual property rights of others. 
+The patent positions for biopharmaceutical companies like us are generally uncertain and can involve complex legal, scientific, and factual issues. In addition, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance. As a result, we cannot guarantee that any of our product candidates will be protectable or remain protected by enforceable patents. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that we hold may be challenged, circumvented or invalidated by third parties. 
+13 
+As of March 3, 2025, our owned patent portfolio is composed of at least 100 pending U.S. and foreign patent applications, 14 granted or allowed U.S. and foreign patents. In addition, we have licensed 14 granted U.S. and foreign patents, and at least 50 pending patent applications in the United States and foreign jurisdictions. 
+Patent Rights Relating to Our eHSC Programs 
+The patent portfolio related to our lead eHSC product candidate, trem-cel (formerly VOR33), includes four patent families that are exclusively licensed from Columbia. The first patent family licensed from Columbia is directed to compositions and methods for gene engineering lineage-specific cell surface antigens, such as CD33, in HSCs and use thereof, and includes 13 granted or allowed U.S. and foreign patents, two pending U.S. applications and at least 11 pending foreign applications in Europe, Japan, Canada, China, Australia and other jurisdictions. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2036, absent any applicable patent term extensions. 
+As of March 3, 2025, the second patent family licensed from Columbia, directed to compositions and methods of use of HSCs containing a single nucleotide polymorphism in CD33, includes an issued U.S. patent, one pending U.S. application, and two pending foreign applications in Europe and Japan. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2038, absent any applicable patent term extensions. 
+As of March 3, 2025, the third patent family licensed from Columbia, directed to compositions and methods for gene engineering CD33 in HSCs and use thereof, includes a pending U.S. application and at least 14 pending foreign applications in Europe, Japan, Canada, China, Australia and other jurisdictions. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2040, absent any applicable patent term extensions. 
+As of March 3, 2025, the fourth patent family licensed from Columbia, directed to compositions and methods for inhibition of lineage-specific cell antigens using CRISPR-based base editor systems in HSCs and use thereof, includes a pending U.S. application and at least 8 pending foreign applications in Europe, Japan, Canada, China, and Australia and other jurisdictions. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2041, absent any applicable patent term extensions. 
+The patent portfolio related to trem-cel or gene-edited HSCs also includes three patent families that we own. As of March 3, 2025, the first family, directed to compositions and methods of engineering lineage-specific antigens in HSCs includes five granted or allowed U.S. and foreign patents, one pending patent application in the United States and 6 pending foreign applications in Europe, Japan, Canada, China, Australia and other jurisdictions. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2038, absent any applicable patent term extensions. As of March 3, 2025, the second family, directed to compositions and methods of engineering multiple lineage-specific antigens in HSCs, includes nine granted or allowed U.S. and foreign patents, one pending U.S. patent applications and 12 pending foreign patent applications. Any patents that grant from applications within these families would be expected to expire in 2039, absent any applicable patent term extensions. As of March 3, 2025, the third family, directed to compositions and methods of treating a hematopoietic malignancy, includes a pending U.S. application and seven pending foreign applications in Europe, Japan, Canada, China, Australia, and other jurisdictions. Any patents that grant from applications within this family would be expected to expire in 2041, absent any applicable patent term extensions. 
+We also own five patent families directed to compositions and methods of engineering specific antigens in HSCs, including CD33, CLL-1 and CD123. As of March 3, 2025, the first family, directed to compositions and methods for engineering CD33 in HSCs includes one pending U.S. application. As of March 3, 2025, the second and third patent families, directed to compositions and methods for engineering CLL-1 in HSCs include at least two pending U.S. applications and five pending foreign patent applications. As of March 3, 2025, the fourth and fifth patent families, directed to compositions and methods for engineering CD123 in HSCs include at least two pending U.S. applications and five pending foreign applications. 
+14 
+We also own four patent families directed to compositions and methods of engineering additional target antigens in HSCs. These families include at least four pending U.S. applications and at least four pending foreign patent applications. Any patents that grant from applications within these families would be expected to expire in 2041 or 2042, absent any applicable patent term extensions. 
+We also own patent families directed to compositions and methods of generating genetically engineered cells using homology-directed repair, epitope engineering, multiplex engineering and generating an artificial protospacer-adjacent motif. These patent families each include at least 3 pending U.S. applications and 9 foreign patent applications. Any patents that grant from applications within these patent families would be expected to expire in 2042 or 2043, absent any applicable patent term extensions. 
+Patent Rights Relating to Our Targeted Therapy Programs 
+We own three patent families directed to compositions and methods of making and using CARs. As of March 3, 2025, these families each include one pending U.S. application and at least two pending foreign patent applications, and any patents that grant from applications in these families would be expected to expire in 2041, absent any applicable patent term extensions. 
+We have one patent family that is exclusively licensed from the NIH related to our VCAR33 program. As of March 3, 2025, the patent family licensed from NCI is directed to CARs targeting CD33, compositions containing cells expressing CARs, and methods of use thereof, and includes one pending U.S. application and at least 13 pending foreign applications in Europe, Japan, Canada, China, Australia and other countries. Any patents that grant from applications in this patent family would be expected to expire in 2039, absent any applicable patent term extensions. 
+We own one patent family directed to compositions and methods of using single domain antibodies targeting CD33. As of March 3, 2025, this family includes one pending U.S. patent application and six pending foreign patent applications. Any patents that grant from applications in this family would be expected to expire in 2041, absent any applicable patent term extensions. 
+We own one patent family directed to compositions and methods of using CARs targeting CD123. As of March 3, 2025, this family includes one pending U.S. patent application. Any patents that grant from applications in this family would be expected to expire in 2042, absent any applicable patent term extensions. 
+We also own one patent family directed to compositions and methods of using antibodies targeting CLL-1. As of March 3, 2025, this family includes one pending U.S. patent application and five pending foreign patent applications. Any patents that grant from applications in this family would be expected to expire in 2043, absent any applicable patent term extensions. 
+Provisional Patent Applications 
+As indicated above, some of our owned patent applications are provisional patent applications. Provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing of one or more of our related provisional patent applications. If we do not timely file any non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. While we intend to timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents that provide us with any competitive advantage. Moreover, the patent application and approval process is expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. 
+15 
+Patent Term and Term Extensions 
+The term of individual patents depends upon the legal term for patents in the countries in which they are obtained. In most countries in which we have filed, including the United States, the patent term is 20 years from the earliest filing date of a non-provisional patent application. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent. The term of a patent that covers a drug or biological product may also be eligible for patent term extension when FDA approval is granted for a portion of the term effectively lost as a result of the FDA regulatory review period, subject to certain limitations and provided statutory and regulatory requirements are met. Any such patent term extension can be for no more than five years, only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from FDA approval, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. We may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. In the future, if and when our product candidates receive approval from the FDA or foreign regulatory authorities, we expect to apply for patent term extensions on issued patents we may obtain in the future covering those products, depending upon the length of the clinical trials for each product and other factors. There can be no assurance that any of our pending patent applications will issue or that we will benefit from any patent term extension or favorable adjustment to the term of any of our patents. 
+As with other biotechnology and pharmaceutical companies, our ability to maintain and solidify our proprietary and intellectual property position for our product candidates will depend on our success in obtaining effective patent claims and enforcing those claims if granted. However, our owned and licensed pending patent applications, and any patent applications that we may in the future file or license from third parties may not result in the issuance of patents. We also cannot predict the breadth of claims that may be allowed or enforced in our patents. Any issued patents that we may receive in the future may be challenged, invalidated, infringed or circumvented. In addition, because of the extensive time required for clinical development and regulatory review of a product candidate we may develop, it is possible that, before any of our product candidates can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby limiting the protection such patent would afford the respective product and any competitive advantage such patent may provide. For more information, see the section entitled “Risk Factors—Risks Related to Intellectual Property.” 
+Other IP Rights 
+In addition to patents, we rely upon unpatented trade secrets and know-how, continuing technological innovation and confidential information to develop and maintain our proprietary position and protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection, including our proprietary processes for generating and propagating eHSCs. However, trade secrets and know-how can be difficult to protect. We seek to protect our proprietary information, in part, by executing confidentiality agreements with our collaborators and scientific advisors, and non-competition, non-solicitation, confidentiality and invention assignment agreements with our employees and consultants. We have also executed agreements requiring assignment of inventions with selected scientific advisors and collaborators. The confidentiality agreements we enter into are designed to protect our proprietary information and the agreements or clauses requiring assignment of inventions to us are designed to grant us ownership of technologies that are developed through our relationship with the respective counterparty. We cannot guarantee, however, that we have executed such agreements with all applicable counterparties, such agreements will not be breached, or that these agreements will afford us adequate protection of our intellectual property and proprietary rights. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our commercial partners, collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. For more information, see the section entitled “Risk Factors—Risks Related to Our Intellectual Property” in Part I,

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+Certain Relationships and Related Transactions, and Director Independence 
+107

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+0001817229,VOR,Vor Biopharma Inc.,2025,10-K,2026-03-30,2025-12-31,2026-03-30T12:03:04.000Z,0001193125-26-130451,vor-20251231.htm,10-K,12027797,1,1,https://www.sec.gov/Archives/edgar/data/1817229/000119312526130451/vor-20251231.htm,https://www.sec.gov/Archives/edgar/data/1817229/000119312526130451/

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+Item 13 
+Certain Relationships and Related Transactions, and Director Independence 
+97

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+cik,ticker,company_name,year,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url
+0001817232,HGASW,Global Gas Corp,2024,10-K,2025-03-31,2024-12-31,2025-03-31T20:01:44.000Z,0001213900-25-026224,ea0234415-10k_global.htm,ANNUAL REPORT,4874022,1,1,https://www.sec.gov/Archives/edgar/data/1817232/000121390025026224/ea0234415-10k_global.htm,https://www.sec.gov/Archives/edgar/data/1817232/000121390025026224/

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+ITEM 1. BUSINESS 
+Overview 
+Global Gas is a nascent pure-play
+hydrogen and carbon recovery project developer and industrial gas supplier that has commenced initial operations and is building a growing
+project development pipeline. Since its inception, Global Gas has worked to establish relationships in the form of channel checks with
+non-exclusive independent equipment suppliers and discussions with vendors, but the Company has not yet generated any revenue or reached
+final terms with any paying customers or suppliers. As we expand our operations, we intend to offer potential customers reliable, low-carbon
+and clean hydrogen, pure carbon dioxide, and other gases generated from a variety of feedstocks. We intend for our operations to include
+(i) the sourcing, identification, evaluation and vetting of offtake customers seeking to purchase industrial gases, (ii) the securing
+of local feedstocks, equipment, and utilities, (iii) the planning and management of projects and (iv) the structuring and financing of
+our projects. We intend to offer our customers attractive pricing as we select and secure local, often waste, feedstock, and plan to deploy
+established industrial gas generation, storage, compression, and dispensing technologies in our projects. On each planned project, we
+seek to sell multiple gas products, sourced from a single feedstock, for offtake to customers. We also intend to utilize and bring to
+market secondary offtake products such as oxygen. The Company was founded in 2023 by a team with over a decade of hydrogen experience
+and several decades of business development, mergers & acquisitions and capital markets experience. Global Gas targets both privately-
+and publicly-funded hydrogen development and selected carbon recovery projects, including projects supported by local, county, state and
+national-level governments in North America, Western Europe and Great Britain. 
+Global Gas is building a
+growing project development pipeline. Potential projects are added to the project development pipeline only after Global Gas has met with
+the potential customer, discussed the scope of the project and discussed the project’s feasibility, preliminary sizing and design.
+To date, we do not have any customers and have not generated any revenue. In 2025, Global Gas plans to focus primarily on selling systems
+and equipment. In selling systems and equipment, Global Gas anticipates that potential customers will retain responsibility for applying
+for and receiving regulatory approvals, acquiring land for properties, and overseeing the commencement of civil works for hydrogen refueling
+station construction. Global Gas expects to generate revenue upon the sale of systems and equipment, including but not limited to alkaline
+and proton exchange membrane electrolyzers, steam methane reforming plants, carbon recovery plants, hydrogen and natural gas compressors,
+pumps and storage tanks, heat exchangers, hydrogen dispensing systems, gas analyzers and flow meters, which will be purchased from wholesalers
+and provided to customers at market prices. The Company also intends to recognize revenue upon achieving certain milestones, including
+but not limited to signing of contracts, purchase of long-term lead time items, testing of plants and notification of readiness to dispatch
+plants. Additionally, the Company may also provide engineering, procurement, construction supervision (EPC), design, testing, installation,
+commissioning, plant startup, plant maintenance and operation, site selection, project economic analysis, and project management services
+to customers and support customers with supervisory services related to installation, commissioning, startup and operation of production
+facilities or other services as may be required by a customer’s project. Outside of software licenses, no licensing of intellectual
+property is expected to be necessary for the sale or use of equipment by customers. In connection with these services, the Company anticipates
+hiring additional personnel as needed with relevant skills and experiences in order to support customers. 
+In selecting feedstock to
+generate industrial gases, we will primarily target renewable waste and will need to seek arrangements with owners of renewable waste
+feedstock, such as wastewater treatment plants, landfills, food waste processing facilities, and agricultural farms, to access their renewable
+waste feedstock. In addition to generating industrial gases from renewable waste feedstock, we plan to generate gases from non-renewable
+sources including pipeline natural gas. We will need to seek arrangements with owners of such non-renewable feedstock. On projects where
+a non-renewable, or high greenhouse gas (“GHG”) output, energy source is used, as well as on selected other projects where
+such technology is required to produce clean hydrogen, we may deploy carbon recovery technology — more commonly known
+as carbon capture technology. Renewable waste feedstock has an additional advantage in that its price may be less susceptible to market
+fluctuations as compared to other feedstocks such as natural gas. 
+1 
+On the hydrogen side, we
+intend to serve traditional industrial gas customers, and are particularly focused on plans to serve the rapidly growing hydrogen-as-energy-carrier
+market, comprising heavy duty hauling transportation operators such as transit bus agencies, long haul truck fleet operators, truck leasing
+operators and refuse collection truck operators, many of whom are considering deploying hydrogen fuel cell powertrain vehicles to decarbonize
+their fleets which currently runs almost exclusively on diesel. On the carbon dioxide side, we target both traditional industrial users
+of the gas, including food & beverage grade users such as brewers and beverage bottlers requiring carbonation, as well as emerging
+users such as the producers of green building materials. 
+Global Gas intends for its
+business model to generate revenue from the sale of equipment and systems and, in the long-term, from the sale of industrial gases from
+its owned plants. While Global Gas does not anticipate earning revenue in connection with its long-term business model in 2025, the Company
+has commenced discussions with potential hydrogen offtake customers about their hydrogen needs in connection with gas sales and Global
+Gas is exploring potential hydrogen feedstock sources and hydrogen production locations for these owned plants. To generate revenue from
+the Company’s long-term business model of owning plants and selling hydrogen and other gases, Global Gas will need to identify and
+contract with offtake customers. To streamline anticipated regulatory approvals for hydrogen production projects, the Company plans to
+target offtake partners who have already received or are in the process of receiving regulatory approvals for their specific plant sites.
+Additionally, the Company plans to identify production locations and project types where accelerated regulatory approval is possible.
+As an example, certain subdivisions of state and local governments have the ability to provide regulatory approvals and permits for projects
+to proceed, including the ability to issue building permits, fire marshal certifications, and air quality permits. In instances where
+the offtake partner does not have a permitted project site, Global Gas anticipates project permit approvals can be received in timeframes
+ranging from 6 months to several years, depending on the locality and regulatory body. Once permitting is received by the offtake partner
+or issued by the authority having jurisdiction, it is the belief and expectation of Global Gas’ management that Global Gas will
+be able to manufacture, commission, and startup our hydrogen plants in 6 to 9 months for Global Gas’ electrolyzer offerings and
+12 to 18 months for SMR plants, depending on the size, quantity, and destination of the plant. Global Gas anticipates beginning to execute
+its long-term business model and generating revenue from such long-term business model in 2026. For owned plants, Global Gas does not
+anticipate significant exposure to fluctuations in the market for hydrogen due to the planned execution of long-term offtake agreements
+with its customers. 
+As described below under
+the caption “ Growth Strategy ,” our growth strategy is based on being able to place modular generation, recovery, storage
+and dispensing solutions in closer geographic proximity to our end customers — onsite in many cases — and
+our ability to produce and sell multiple outputs from a single feedstock input. We hope that these plans, if successfully carried out,
+will allow us to produce clean hydrogen and carbon dioxide at a net cost significantly below the $16 to $25 per kilogram currently offered
+at many retail hydrogen fueling stations, and which supports competitive market prices for our end products. Additionally, governments
+at all levels in North America and Western Europe have and are deploying substantial incentives to mitigate the impact of climate change
+and to decarbonize their economies. With our focus on proven, low-carbon hydrogen generation and carbon recovery technologies —
+such as electrolyzers — which produce no carbon dioxide if sourced from renewable energy sources — and steam methane
+reforming plants with co-located carbon recovery — we believe we are well-placed to benefit as a developer of projects eligible
+for several of these incentives, such as the hydrogen tax production credits and the investment tax credits made available in the United
+States through the recently enacted Inflation Reduction Act, which offers up to $3.00 per kilogram in incentive credits for 10 years,
+for clean hydrogen produced while generating less than 0.45 kilograms of carbon dioxide emission for every 1.0 kilogram of hydrogen produced. 
+Market Opportunity 
+Hydrogen is the first element
+in the periodic table, it has the lightest molecular weight and the highest specific heat capacity of any element. Burning hydrogen releases
+no carbon dioxide, and when used in a hydrogen fuel cell to produce electricity, the outputs are water and heat. These special characteristics,
+and others, make hydrogen a strong choice for industries with end use applications facing significant weight or heat considerations, such
+as heavy duty hauling, steel production, certain industrial chemical manufacturing, and aviation and shipping/maritime transport, which
+otherwise represent difficult-to-decarbonize sectors of the economy. Historically, hydrogen has been produced and used primarily for industrial
+purposes — notably as a chemical raw material for the production of ammonia and methanol, and in oil refining. 
+2 
+Methods of Hydrogen Production 
+As indicated in “The
+Landscape of Clean Hydrogen” by Carbon Solutions in association with the Industrial Innovation Initiative, Hydrogen can be produced
+in a number of ways by applying different forms of energy to a variety of raw materials known as feedstocks. The most mature and economic
+method of producing hydrogen is via SMR, which is catalytic steam reforming of natural gas. In SMR hydrogen generation, feedstock natural
+gas methane (CH4) is reacted with steam, and molecular hydrogen (H2) is separated from the carbon (C). Based on Global Gas’s analysis
+of IEA publications, Global Gas believes that without carbon capture, SMR hydrogen production is considered to be a carbon-intensive method
+of production, as the separated carbon in the SMR process which reacts with oxygen (O2) is released into the atmosphere at an approximate
+ratio of 10:1 (10 kilograms of carbon dioxide (CO2) for every 1 kilogram of H2). With carbon capture, hydrogen can be produced via SMR
+at a ratio below 1:1. 
+● 
+The above chart reflects IEA analysis of the readiness level of certain hydrogen production technologies based upon information sourced from the U.S. Department of Energy. Technologies with higher numbers are more mature technologies, which have been demonstrated and are ready for large scale deployment. It is Global Gas’s opinion that alkaline and proton exchange membrane electrolyzers and steam methane reforming plants with advanced carbon capture, systems and equipment which Global Gas intends to sell, are demonstrated and mature technologies. 
+● 
+Notes: AEM = anion exchange membrane; ALK = alkaline; ATR = autothermal reforming; GHR = gas-heated reforming; LOHC = liquid organic hydrogen carrier; PEM = proton exchange membrane; SOEC = solid oxide electrolyzer cell. Source of the chart is IEA data found at https://iea.blob.core.windows.net/assets/787357a0-ce67-4c03-aa99-d4018aa67698/20211124-IEA-EGRD_JBermudez.pdf and Global Gas analysis. 
+3 
+Hydrogen also can be produced
+electrolytically using an electrolyzer to separate the hydrogen and oxygen molecules in water (H2O). Based on U.S. Department of Energy,
+National Renewable Energy Lab data, production of hydrogen via electrolysis produces no CO2, but today requires 50 to 55 kilowatt hours
+of electrical energy to isolate a kilogram of hydrogen, the generation of such electricity may produce GHGs. The price and lifecycle carbon
+emissions of hydrogen produced via both SMR and electrolysis is highly dependent on the price and emission profile of the inputs. For
+SMR production methane is the primary cost input, water and electricity are also inputs but generally not major cost drivers, and for
+electrolyzers electricity and water are the primary cost inputs. Cleaner, low carbon inputs produce lower emission, lower carbon hydrogen.
+Global Gas intends to use hydrogen generation technologies which are proven, tested, and have been in production for many years, focusing
+on technologies considered by the IEA to be mature or with high technology readiness levels above 8, a metric used by many U.S. government
+agencies to assess maturity of evolving technologies, indicating that the technology has been proven to work in its final form and under
+expected conditions, though we reserve the option to use other technologies depending on customer requirements. Global Gas believes material
+technological improvements or discoveries are not necessary in order to commercialize the hydrogen and carbon recovery products and gases
+that we intend to sell. The hydrogen generation and carbon recovery technologies we will offer to customers will be purchased from suppliers
+and vendors and sold to customers or used by us to produce industrial gases which we sell to customers. As such, we do not currently own
+material intellectual property beyond certain logos and domain names. 
+New Uses of Hydrogen 
+While the traditional uses
+of hydrogen as an industrial chemical are expected to continue, based on its review of U.S. Department of Energy data, Global Gas believes
+hydrogen, especially low carbon hydrogen, is increasingly being considered for use as an energy carrier. According to publications of
+the U.S. Department of Energy, National Renewable Energy Lab, including Optimized Hydrogen and Electricity Generation from Wind, and Wind-To-Hydrogen
+Project: Electrolyzer Capital Cost Study, Global Gas believes that when passed through a hydrogen fuel cell, each kilogram of hydrogen
+holds 33.3 to 39.4 kilowatt hours of energy, which, when passed through a hydrogen fuel cell reacts the hydrogen fuel with oxygen
+to produce electricity, along with water and a small amount of heat. Because hydrogen can store significantly more energy by weight or
+volume than traditional batteries, and fuel cell-powered electric vehicles can be refueled quickly relative to battery recharge times
+of electrical vehicles, low carbon hydrogen is seen by the Clean Air Task Force and the American Transportation Research Institute as
+a potential replacement fuel in heavy duty transport sectors, which currently run almost exclusively on diesel. 
+Growth Strategy 
+To date, hydrogen has not
+been widely used as an energy carrier for a number of reasons including: 
+1. 
+a dearth of fuel cell vehicles in production; 
+2. 
+a lack of economic incentives of fleet operators to decarbonize; and 
+3. 
+a lack of available hydrogen infrastructure in populated areas where hydrogen can be most useful in decarbonizing transportation. 
+Changing market conditions
+and government policy incentives favoring decarbonization have altered the landscape for fuel cell vehicle production and economic incentives
+for fleet operators. Global Gas’ growth strategy focuses on the lack of available hydrogen infrastructure in populated areas, and
+we seek to become the largest provider of clean, low carbon hydrogen in the top 100 US markets by population size. 
+Global Gas intends to grow
+through a reliance on our team’s knowledge of the landscape of feedstocks, hydrogen generation, storage, and dispensing technologies,
+the professional network of our team which provides access to project development deal flow opportunities that may not be available to
+competitors, and through our ability to offer attractive hydrogen pricing to our clients based on their specific geographic and volumetric
+requirements and the feedstocks available in their areas. 
+4 
+There are three foundations
+to our growth strategy: 
+Production Margin of Safety. Global
+Gas strives to offer a competitive cost of hydrogen production by planning to locate and secure the highest quality, lowest cost,
+reliable local feedstock and the most appropriate technology for each of our development projects. 
+Generation Technology Agnostic 
+We plan to deploy a diverse network
+of equipment and technology suppliers, to produce hydrogen potentially utilizing steam methane reformers, alkaline electrolyzers, and
+proton exchange membrane (“PEM”) electrolyzers. Both alkaline and PEM electrolyzers use electricity to split water into hydrogen
+and oxygen gas molecules. However, the different systems use different electrolytes and membranes to separate the cathodes and anodes.
+PEMs produce hydrogen at a high purity, but are typically used on a smaller scale, while alkaline electrolyzers typically produce hydrogen
+on a large scale but lower purity hydrogen than PEM electrolyzers. National Renewable Energy Laboratory data indicates alkaline electrolyzers
+can reach greater than 99.3% purity and PEMs can reach greater than 99.9% purity. We plan to evaluate projects requiring hydrogen volumes
+of 100 normal cubic meters per hour (nm3h), roughly 400 to 500 kilowatts per hour, to 14,000 nm3h. We also intend to evaluate the production
+technology required on a project by project basis, and negotiate with our suppliers to size production capacity and plant, storage, compression
+and dispensing equipment and footprint appropriately to meet customer needs. 
+Feedstock Flexibility 
+As we are generation technology agnostic,
+we plan to work with both renewable and non-renewable feedstocks, including but not limited to anaerobic digester gas, landfill gas, pipeline-delivered
+biomethane, pipeline natural gas, liquid propane gas, and renewable or grid electricity. 
+Waste-to-Energy Focus 
+To lower both the carbon intensity
+and cost of the hydrogen we produce, we target waste feedstock for hydrogen production and existing CO2 emitters for CO2 recovery. 
+Distribution Diversity. We
+plan to sell hydrogen, CO2 and select other gases to industrial and hydrogen-as-an-energy-carrier customers that require high purity,
+reliable, cost-effective gas in bulk, dewar and cylinder volumes. We also plan to sell hydrogen generation and carbon dioxide recovery
+plants which are manufactured by our suppliers. 
+Single Input; Multiple Outputs 
+A key tenant of our growth strategy
+is to maximize the number of outputs we are able to achieve from a single feedstock input. We plan to evaluate and design projects to
+match the volumes of gases required by local offtake clients. Once a primary gas offtake and offtake customer have been identified, we
+plan to construct a full offtake plan for the project, taking into account the identified location of gas production, storage and dispensing,
+local feedstock availability, potential for additional local offtake customers of gases we could produce, and the local potential for
+merchant (spot) gas sales. We believe that all projects which successfully pass our design stage will typically support multiple gas output
+products. 
+Offtake/Merchant Mix 
+Designing projects with multiple outputs
+enables us to price gas we sell opportunistically, which we believe will enable us to achieve attractive end user pricing for both offtake
+(long term) and merchant (spot) customers. We believe our projects will typically have a target 70% or better offtake to merchant sales
+mix, and ideally all hydrogen produced would be sold on long-term contracts, — meaning, to successfully pass our project evaluation
+process for owned plants, we typically will have in hand, prior to approval of the project, letters of intent or customer commitments
+to purchase 70% or more of the project’s output. As such, for owned plants, Global Gas does not anticipate significant exposure
+to fluctuations in the market for hydrogen. 
+5 
+Low Lifecycle Carbon Intensity. We
+plan to design our projects so that the hydrogen we produce and CO2 we recover will have as low a lifecycle carbon intensity as practical.
+We believe that some of our future projects, from feedstocks such as wastewater, will produce hydrogen with neutral or negative carbon
+intensity. 
+● 
+The above chart reflects analysis by Global Gas based upon IEA, Rocky Mountain Institute, Princeton University, Hydrogen Council and International Council on Clean Transportation data. 
+Co-Location 
+Our strategy is
+to co-locate our hydrogen generation and carbon dioxide recovery plants as close to or even on-site with storage, compression and dispensing/refueling
+assets so that distribution costs are minimized or eliminated. We intend to select small, modular generation and recovery equipment manufactured
+by our suppliers for our projects so that we can place our “Gen/Fill” systems close to population centers where low-carbon
+clean hydrogen fuel and CO2 are most needed, and where CO2 recovery and capture is most beneficial. 
+6 
+Recovery and Reuse 
+Co-locating our
+Gen/Fill systems near existing CO2 emitters and population centers has the added advantage of increasing our ability to recover and reuse
+anthropogenic waste as source feedstock for the generation of the gases we sell. 
+Suppliers 
+We source equipment,
+components, and parts from a global network of specialized industrial suppliers. Suppliers are chosen to meet individual project and customer
+requirements, and are vetted based on performance, experience, and support. Global Gas’ electrolyzer and SMR equipment suppliers
+purchase raw materials and build components which are assembled into the hydrogen generation and carbon recovery plants, which we intend
+to co-locate, integrate, commission and start-up. Therefore, we are exposed, indirectly, to world prices for raw materials such as steel,
+nickel and other commodities, which are used in the components in our plants. We anticipate that our principal suppliers are equipment
+manufacturers, compressor manufacturers, and instrument suppliers such as Emerson, PDC Machines, and Unicat Catalysts. Global Gas may
+use the services of subcontractors to fabricate or manufacture portions or all of the unique and customer-specific hydrogen generation
+and carbon recovery equipment we sell to customers. Global Gas anticipates initially generating revenue through the sale of customer-specific
+hydrogen generation and carbon recovery equipment and solutions sold to customers. 
+Global Gas’ Competitive Strengths 
+Global Gas believes that
+other industrial gas suppliers of hydrogen target larger production capacities, which require greater amounts of feedstock, and their
+production facilities are often located in industrial clusters located far from population centers where gas for hydrogen-as-an-energy-carrier
+use cases are growing in prevalence. Projects which successfully pass our design stage are designed to exploit this opportunity: our projects
+will provide on-site or nearby Gen/Fill systems which dramatically reduce or eliminate distribution costs and we are able to use local,
+often waste, feedstock both to recover and reuse local waste, assist in reducing local CO2 emissions, and produce low carbon hydrogen,
+CO2, and other gases at economically attractive prices making fuel cell heavy duty transportation competitive with diesel. 
+Products & Services 
+Global Gas will primarily
+sell hydrogen, recovered CO2, and oxygen to offtake and merchant customers requiring gas for industrial and emerging hydrogen-as-an-energy-carrier
+use cases. We focus our selling efforts in North America, Western Europe and Great Britain, though we may consider opportunities outside
+of those geographies. We plan to design our projects to meet a wide range of customer requirements, including end use application, volume
+and type of gas required, location of gas need, redundancy requirements, budget, space available and other considerations. A project could
+have either hydrogen or CO2 as the primary offtake gas. We also may, selectively sell hydrogen generation, CO2 recovery, or other related
+equipment such as compressors and dispensers, when requested by our customers and manufactured by our suppliers. 
+We also plan to offer services
+related to the sale of our products. Depending on the product sold, these services could include professional services, plant commissioning
+and startup services, aftermarket spare parts, or plant operation services. 
+Human Capital Resources 
+As of March 31, 2025, Global
+Gas has two full-time employees, our Executive Chairman, Carter Glatt, and our Chief Operating Officer and Chief Financial Officer, Shachi
+Shah. Our human capital management objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating
+future employees. 
+Competition 
+We expect to generate revenue
+and income from the resale and leasing of systems and equipment, the resale of hydrogen gas purchased from other industrial suppliers,
+and the sale of value-added technical services such as: design, engineering and plant costing; project management; plant installation,
+plant commissioning, and plant startup; supervision of plant installation, plant commissioning and plant startup; and project structuring. 
+7 
+We compete with firms which
+manufacture, resell, and lease hydrogen equipment and infrastructure, and also with global industrial and regional gas suppliers who sell
+hydrogen, CO2 and air separation gases. 
+Competition in the systems
+and equipment and technical services business is based primarily on plant design and efficiency, quality of service, technical know-how,
+price, and delivery timelines, in addition to plant and equipment technology and performance guarantees. Competition in industrial gases
+is based primarily on price (absolute price and volatility of price), reliability of supply, ease of delivery, and end user application. 
+Customers 
+Our target customers are
+heavy duty fleet operators, owners of anaerobic digesters, landfills, renewable natural gas producers, other industrial gas distributors
+and traditional industrial chemical users of hydrogen. 
+Facilities 
+Our headquarters are located
+in New York, New York. We believe our current facilities are adequate for our current operating needs. 
+Corporate History 
+On December 21, 2023 (the
+“Closing Date”), the Company, a Delaware corporation (formerly known as Dune Acquisition Corporation) (prior to the Effective
+Time (as defined below), “Dune”), consummated the previously-announced business combination (“Business Combination”)
+pursuant to that certain Unit Purchase Agreement, dated May 14, 2023 (as amended on August 22, 2023 and as further amended on November
+24, 2023, the “Purchase Agreement”), by and among Dune, Holdings, a Delaware limited liability company and direct, wholly-owned
+subsidiary of Dune, Global Hydrogen, a Delaware limited liability company, and William Bennett Nance, Jr., Sergio Martinez and Barbara
+Guay Martinez (collectively, the “Sellers”), the equity holders of Global Hydrogen. 
+In connection with the closing
+of the Business Combination, Dune changed its name from Dune Acquisition Corporation to Global Gas Corporation, and on December 22, 2023,
+the Company’s Class A Common Stock (as defined below) and warrants began trading on Nasdaq under the new trading symbols “HGAS”
+and “HGASW,” respectively. 
+In accordance with the terms
+and subject to the conditions of the Purchase Agreement and the other transactions contemplated thereby, at the closing of the Business
+Combination (the “Closing”), (a) Dune contributed to Holdings all of its assets (excluding its interests in Holdings and the
+aggregate amount of cash proceeds required to satisfy redemptions by Dune’s public stockholders (“Stockholder Redemptions”)),
+and in exchange therefor, Holdings issued to Dune a number of common equity units of Holdings (“Holdings Common Units”) which
+equal the number of total shares of Class A common stock, par value $0.0001 per share (“Class A Common Stock”), of Dune issued
+and outstanding immediately after the Closing (giving effect to all Stockholder Redemptions) (such transactions, the “SPAC Contribution”)
+and (b) immediately after the SPAC Contribution, the Sellers transferred, conveyed, assigned and delivered all of the limited liability
+company equity interests of Global Hydrogen (“Global Hydrogen Units”) to Holdings in exchange for shares of Class B voting
+non-economic common stock, par value $0.0001 per share (“Class B Common Stock”), of Dune and Holdings Common Units (together
+with the SPAC Contribution, the “Combination Transactions”), as a result of which, (i) each issued and outstanding Global
+Hydrogen Unit immediately prior to the Combination Transactions is now held by Holdings, (ii) each Seller received an aggregate number
+of Holdings Common Units and shares of Class B Common Stock, in each case, equal to the number of Global Hydrogen Units held by such Seller,
+multiplied by the applicable exchange ratio, and (iii) Dune changed its name to Global Gas Corporation and the Company became the publicly
+traded reporting company. The effective time of the Business Combination on the Closing Date is referred to herein as the “Effective
+Time.” 
+8 
+The Business Combination
+was accomplished through what is commonly referred to as an “Up-C” structure, which is often used by partnerships and limited
+liability companies undertaking an initial public offering. The “Up-C” structure allowed the Sellers, who became equity holders
+of Holdings upon the consummation of the Combination Transactions, to retain their equity ownership in Holdings, an entity that is classified
+as a partnership for United States federal income tax purposes, in the form of Holdings Common Units after the Closing, and provides potential
+future tax benefits for both the Company and Holdings’ equity holders (other than the Company) after the Closing when they ultimately
+exchange their Holdings Common Units. 
+In accordance with the terms
+and subject to the conditions of the Purchase Agreement, at the Closing, the issued and outstanding Global Hydrogen Units of each Seller
+were transferred, conveyed, assigned and delivered in exchange for (i) a number of shares of Class B Common Stock equal to the product
+of (x) the number of Global Hydrogen Units held by such Seller and (y) the exchange ratio determined by dividing (A) the quotient of $43,000,000
+divided by the number of Global Hydrogen Units issued and outstanding immediately prior to the Closing by (B) $10.00 per share and (ii)
+a number of Holdings Common Units equal to the number of shares of Class B Common Stock received by such Seller pursuant to clause (i)
+hereof. 
+In connection with the Business
+Combination, on December 1, 2023, Dune and Global Hydrogen entered into a forward purchase agreement (the “Forward Purchase Agreement”)
+with each of Meteora Strategic Capital, LLC (“MSC”), Meteora Capital Partners, LP (“MCP”) and Meteora Select Trading
+Opportunities Master, LP (“MSTO” and, collectively with MSC and MCP, the “Meteora Entities”) for an OTC Equity
+Prepaid Forward Transaction. In connection with the Forward Purchase Agreement, Dune entered into a subscription agreement (the “Subscription
+Agreement”) with the Meteora Entities. Pursuant to the Subscription Agreement, the Meteora Entities agreed to subscribe for and
+purchase, and Dune agreed to issue and sell to the Meteora Entities, on the Closing Date, 681,220 shares of Class A Common Stock in the
+aggregate (the “PIPE Shares”). Pursuant to the Subscription Agreement, the Company gave certain registration rights to the
+Meteora Entities with respect to the PIPE Shares. The sale of the PIPE Shares was consummated concurrently with the Closing. 
+The rights of holders of
+our Class A Common Stock and Warrants are governed by our second amended and restated certificate of incorporation (the “Amended
+and Restated Charter”), our amended and restated bylaws (the “Amended and Restated Bylaws”) and the Delaware General
+Corporation Law (the “DGCL”), and in the case of our outstanding warrants, the Warrant Agreement dated as of December 17,
+2020, between the Company and Continental Stock Transfer & Trust Company (“Continental”), as warrant agent. 
+On June 21, 2024, due to
+the Company’s failure to satisfy the initial listing standards of The Nasdaq Capital Market upon closing of the Company’s
+previously announced business combination in accordance with Nasdaq Rule 5101-2 and specifically, the Company’s inability to demonstrate
+compliance with the Stockholders Equity, Publicly Held Shares, Market Value of Listed Securities and Market Value of Publicly Held Shares
+requirements set forth in Nasdaq Rule 5505, the Company received notice that the Panel had determined to delist the Company’s securities
+from Nasdaq and would suspend trading in its securities on the exchange effective at the open of business on June 25, 2024. Since the
+delisting, the Company’s common stock and warrants have been trading on the OTCQB with trading symbols “HGAS” and “HGASW”,
+respectively. 
+On March 4, 2024, the Company
+entered into forfeiture agreements (the “Forfeiture Agreements”) with certain holders of the Company’s Class B common
+stock. Pursuant to the Forfeiture Agreements, such holders forfeited an aggregate of 1,600,000 shares (the “Forfeited Shares”)
+in exchange for consideration previously received. After the forfeitures of the Forfeited Shares pursuant to the Forfeiture Agreements,
+such holders continue to hold an aggregate of 2,700,000 shares of the Company’s Class B common stock. 
+Additional Information About the Company 
+We maintain our website at
+globalgas.co. The corporate filings of Global Gas, including our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our
+Current Reports on Form 8-K, our proxy statements and reports filed by our executive officers and directors under Section 16(a) of the
+Securities Exchange Act, and any amendments to those filings, are available free of charge on our website, which are uploaded as soon
+as reasonably practicable after we electronically file (or furnish in certain cases) such material with the Securities and Exchange Commission,
+and can also be found at the SEC’s website at http://sec.gov. We do not intend for any information contained in our website to be
+a part of this Annual Report. 
+9

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+Item 13. 
+Certain Relationships and Related Transactions, and Director Independence 
+44

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+ITEM 1. BUSINESS 
+Overview 
+Global Gas is a nascent
+pure-play hydrogen and carbon recovery project developer and industrial gas supplier that has commenced initial operations and is
+building a growing project development pipeline. Since its inception, Global Gas has worked to establish relationships in the form
+of channel checks with non-exclusive independent equipment suppliers and discussions with vendors, but the Company has not yet
+generated any significant revenue or reached final terms with any paying customers or suppliers. As we expand our operations, we
+intend to offer potential customers reliable, low-carbon and clean hydrogen, pure carbon dioxide, and other gases generated from a
+variety of feedstocks. We intend for our operations to include (i) the sourcing, identification, evaluation and vetting of offtake
+customers seeking to purchase industrial gases, (ii) the securing of local feedstocks, equipment, and utilities, (iii) the planning
+and management of projects and (iv) the structuring and financing of our projects. We intend to offer our customers attractive
+pricing as we select and secure local, often waste, feedstock, and plan to deploy established industrial gas generation, storage,
+compression, and dispensing technologies in our projects. On each planned project, we seek to sell multiple gas products, sourced
+from a single feedstock, for offtake to customers. We also intend to utilize and bring to market secondary offtake products such as
+oxygen. The Company was founded in 2023 by a team with over a decade of hydrogen experience and several decades of business
+development, mergers & acquisitions and capital markets experience. Global Gas targets both privately- and publicly-funded
+hydrogen development and selected carbon recovery projects, including projects supported by local, county, state and national-level
+governments in North America, Western Europe and Great Britain. 
+Global Gas is building a
+growing project development pipeline. Potential projects are added to the project development pipeline only after Global Gas has met with
+the potential customer, discussed the scope of the project and discussed the project’s feasibility, preliminary sizing and design.
+To date, we do not have any customers and have not generated any revenue. In 2026, Global Gas plans to focus primarily on selling systems
+and equipment. In selling systems and equipment, Global Gas anticipates that potential customers will retain responsibility for applying
+for and receiving regulatory approvals, acquiring land for properties, and overseeing the commencement of civil works for hydrogen refueling
+station construction. Global Gas expects to generate revenue upon the sale of systems and equipment, including but not limited to alkaline
+and proton exchange membrane electrolyzers, steam methane reforming plants, carbon recovery plants, hydrogen and natural gas compressors,
+pumps and storage tanks, heat exchangers, hydrogen dispensing systems, gas analyzers and flow meters, which will be purchased from wholesalers
+and provided to customers at market prices. The Company also intends to recognize revenue upon achieving certain milestones, including
+but not limited to signing of contracts, purchase of long-term lead time items, testing of plants and notification of readiness to dispatch
+plants. Additionally, the Company may also provide engineering, procurement, construction supervision (EPC), design, testing, installation,
+commissioning, plant startup, plant maintenance and operation, site selection, project economic analysis, and project management services
+to customers and support customers with supervisory services related to installation, commissioning, startup and operation of production
+facilities or other services as may be required by a customer’s project. Outside of software licenses, no licensing of intellectual
+property is expected to be necessary for the sale or use of equipment by customers. In connection with these services, the Company anticipates
+hiring additional personnel as needed with relevant skills and experiences in order to support customers. 
+In selecting feedstock to
+generate industrial gases, we will primarily target renewable waste and will need to seek arrangements with owners of renewable waste
+feedstock, such as wastewater treatment plants, landfills, food waste processing facilities, and agricultural farms, to access their renewable
+waste feedstock. In addition to generating industrial gases from renewable waste feedstock, we plan to generate gases from non-renewable
+sources including pipeline natural gas. We will need to seek arrangements with owners of such non-renewable feedstock. On projects where
+a non-renewable, or high greenhouse gas (“GHG”) output, energy source is used, as well as on selected other projects where
+such technology is required to produce clean hydrogen, we may deploy carbon recovery technology — more commonly known
+as carbon capture technology. Renewable waste feedstock has an additional advantage in that its price may be less susceptible to market
+fluctuations as compared to other feedstocks such as natural gas. 
+1 
+On the hydrogen side, we
+intend to serve traditional industrial gas customers, and are particularly focused on plans to serve the rapidly growing hydrogen-as-energy-carrier
+market, comprising heavy duty hauling transportation operators such as transit bus agencies, long haul truck fleet operators, truck leasing
+operators and refuse collection truck operators, many of whom are considering deploying hydrogen fuel cell powertrain vehicles to decarbonize
+their fleets which currently runs almost exclusively on diesel. On the carbon dioxide side, we target both traditional industrial users
+of the gas, including food & beverage grade users such as brewers and beverage bottlers requiring carbonation, as well as emerging
+users such as the producers of green building materials. 
+Global Gas intends for its
+business model to generate revenue from the sale of equipment and systems and, in the long-term, from the sale of industrial gases from
+its owned plants. While Global Gas does not anticipate earning revenue in connection with its long-term business model in 2026, the Company
+has commenced discussions with potential hydrogen offtake customers about their hydrogen needs in connection with gas sales and Global
+Gas is exploring potential hydrogen feedstock sources and hydrogen production locations for these owned plants. To generate revenue from
+the Company’s long-term business model of owning plants and selling hydrogen and other gases, Global Gas will need to identify and
+contract with offtake customers. To streamline anticipated regulatory approvals for hydrogen production projects, the Company plans to
+target offtake partners who have already received or are in the process of receiving regulatory approvals for their specific plant sites.
+Additionally, the Company plans to identify production locations and project types where accelerated regulatory approval is possible.
+As an example, certain subdivisions of state and local governments have the ability to provide regulatory approvals and permits for projects
+to proceed, including the ability to issue building permits, fire marshal certifications, and air quality permits. In instances where
+the offtake partner does not have a permitted project site, Global Gas anticipates project permit approvals can be received in timeframes
+ranging from 6 months to several years, depending on the locality and regulatory body. Once permitting is received by the offtake partner
+or issued by the authority having jurisdiction, it is the belief and expectation of Global Gas’ management that Global Gas will
+be able to manufacture, commission, and startup our hydrogen plants in 6 to 9 months for Global Gas’ electrolyzer offerings and
+12 to 18 months for SMR plants, depending on the size, quantity, and destination of the plant. Global Gas anticipates beginning to execute
+its long-term business model and generating revenue from such long-term business model in 2026. For owned plants, Global Gas does not
+anticipate significant exposure to fluctuations in the market for hydrogen due to the planned execution of long-term offtake agreements
+with its customers. 
+As described below under
+the caption “ Growth Strategy ,” our growth strategy is based on being able to place modular generation, recovery, storage
+and dispensing solutions in closer geographic proximity to our end customers — onsite in many cases — and
+our ability to produce and sell multiple outputs from a single feedstock input. We hope that these plans, if successfully carried out,
+will allow us to produce clean hydrogen and carbon dioxide at a net cost significantly below the $16 to $25 per kilogram currently offered
+at many retail hydrogen fueling stations, and which supports competitive market prices for our end products. Additionally, governments
+at all levels in North America and Western Europe have and are deploying substantial incentives to mitigate the impact of climate change
+and to decarbonize their economies. With our focus on proven, low-carbon hydrogen generation and carbon recovery technologies —
+such as electrolyzers — which produce no carbon dioxide if sourced from renewable energy sources — and steam methane
+reforming plants with co-located carbon recovery — we believe we are well-placed to benefit as a developer of projects eligible
+for several of these incentives, such as the hydrogen tax production credits and the investment tax credits made available in the United
+States through the recently enacted Inflation Reduction Act, which offers up to $3.00 per kilogram in incentive credits for 10 years,
+for clean hydrogen produced while generating less than 0.45 kilograms of carbon dioxide emission for every 1.0 kilogram of hydrogen produced. 
+Market Opportunity 
+Hydrogen is the first element
+in the periodic table, it has the lightest molecular weight and the highest specific heat capacity of any element. Burning hydrogen releases
+no carbon dioxide, and when used in a hydrogen fuel cell to produce electricity, the outputs are water and heat. These special characteristics,
+and others, make hydrogen a strong choice for industries with end use applications facing significant weight or heat considerations, such
+as heavy duty hauling, steel production, certain industrial chemical manufacturing, and aviation and shipping/maritime transport, which
+otherwise represent difficult-to-decarbonize sectors of the economy. Historically, hydrogen has been produced and used primarily for industrial
+purposes — notably as a chemical raw material for the production of ammonia and methanol, and in oil refining. 
+2 
+Methods of Hydrogen Production 
+As indicated in “The
+Landscape of Clean Hydrogen” by Carbon Solutions in association with the Industrial Innovation Initiative, Hydrogen can be produced
+in a number of ways by applying different forms of energy to a variety of raw materials known as feedstocks. The most mature and economic
+method of producing hydrogen is via SMR, which is catalytic steam reforming of natural gas. In SMR hydrogen generation, feedstock natural
+gas methane (CH4) is reacted with steam, and molecular hydrogen (H2) is separated from the carbon (C). Based on Global Gas’s analysis
+of IEA publications, Global Gas believes that without carbon capture, SMR hydrogen production is considered to be a carbon-intensive method
+of production, as the separated carbon in the SMR process which reacts with oxygen (O2) is released into the atmosphere at an approximate
+ratio of 10:1 (10 kilograms of carbon dioxide (CO2) for every 1 kilogram of H2). With carbon capture, hydrogen can be produced via SMR
+at a ratio below 1:1. 
+● 
+The above chart reflects IEA analysis of the readiness level of certain hydrogen production technologies based upon information sourced from the U.S. Department of Energy. Technologies with higher numbers are more mature technologies, which have been demonstrated and are ready for large scale deployment. It is Global Gas’s opinion that alkaline and proton exchange membrane electrolyzers and steam methane reforming plants with advanced carbon capture, systems and equipment which Global Gas intends to sell, are demonstrated and mature technologies. 
+● Notes:
+AEM = anion exchange membrane; ALK = alkaline; ATR = autothermal reforming; GHR = gas-heated reforming; LOHC = liquid organic hydrogen
+carrier; PEM = proton exchange membrane; SOEC = solid oxide electrolyzer cell. Source of the chart is IEA data found at https://iea.blob.core.windows.net/assets/787357a0-ce67-4c03-aa99-d4018aa67698/20211124-IEA-EGRD_JBermudez.pdf 
+and Global Gas analysis. 
+3 
+Hydrogen also can be produced
+electrolytically using an electrolyzer to separate the hydrogen and oxygen molecules in water (H2O). Based on U.S. Department of Energy,
+National Renewable Energy Lab data, production of hydrogen via electrolysis produces no CO2, but today requires 50 to 55 kilowatt hours
+of electrical energy to isolate a kilogram of hydrogen, the generation of such electricity may produce GHGs. The price and lifecycle carbon
+emissions of hydrogen produced via both SMR and electrolysis is highly dependent on the price and emission profile of the inputs. For
+SMR production methane is the primary cost input, water and electricity are also inputs but generally not major cost drivers, and for
+electrolyzers electricity and water are the primary cost inputs. Cleaner, low carbon inputs produce lower emission, lower carbon hydrogen.
+Global Gas intends to use hydrogen generation technologies which are proven, tested, and have been in production for many years, focusing
+on technologies considered by the IEA to be mature or with high technology readiness levels above 8, a metric used by many U.S. government
+agencies to assess maturity of evolving technologies, indicating that the technology has been proven to work in its final form and under
+expected conditions, though we reserve the option to use other technologies depending on customer requirements. Global Gas believes material
+technological improvements or discoveries are not necessary in order to commercialize the hydrogen and carbon recovery products and gases
+that we intend to sell. The hydrogen generation and carbon recovery technologies we will offer to customers will be purchased from suppliers
+and vendors and sold to customers or used by us to produce industrial gases which we sell to customers. As such, we do not currently own
+material intellectual property beyond certain logos and domain names. 
+New Uses of Hydrogen 
+While the traditional uses
+of hydrogen as an industrial chemical are expected to continue, based on its review of U.S. Department of Energy data, Global Gas believes
+hydrogen, especially low carbon hydrogen, is increasingly being considered for use as an energy carrier. According to publications of
+the U.S. Department of Energy, National Renewable Energy Lab, including Optimized Hydrogen and Electricity Generation from Wind, and Wind-To-Hydrogen
+Project: Electrolyzer Capital Cost Study, Global Gas believes that when passed through a hydrogen fuel cell, each kilogram of hydrogen
+holds 33.3 to 39.4 kilowatt hours of energy, which, when passed through a hydrogen fuel cell reacts the hydrogen fuel with oxygen
+to produce electricity, along with water and a small amount of heat. Because hydrogen can store significantly more energy by weight or
+volume than traditional batteries, and fuel cell-powered electric vehicles can be refueled quickly relative to battery recharge times
+of electrical vehicles, low carbon hydrogen is seen by the Clean Air Task Force and the American Transportation Research Institute as
+a potential replacement fuel in heavy duty transport sectors, which currently run almost exclusively on diesel. 
+Growth Strategy 
+To date, hydrogen has not
+been widely used as an energy carrier for a number of reasons including: 
+1. 
+a dearth of fuel cell vehicles in production; 
+2. 
+a lack of economic incentives of fleet operators to decarbonize; and 
+3. 
+a lack of available hydrogen infrastructure in populated areas where hydrogen can be most useful in decarbonizing transportation. 
+Changing market conditions
+and government policy incentives favoring decarbonization have altered the landscape for fuel cell vehicle production and economic incentives
+for fleet operators. Global Gas’ growth strategy focuses on the lack of available hydrogen infrastructure in populated areas, and
+we seek to become the largest provider of clean, low carbon hydrogen in the top 100 US markets by population size. 
+Global Gas intends to grow
+through a reliance on our team’s knowledge of the landscape of feedstocks, hydrogen generation, storage, and dispensing technologies,
+the professional network of our team which provides access to project development deal flow opportunities that may not be available to
+competitors, and through our ability to offer attractive hydrogen pricing to our clients based on their specific geographic and volumetric
+requirements and the feedstocks available in their areas. 
+4 
+There are three foundations
+to our growth strategy: 
+Production Margin of Safety. Global
+Gas strives to offer a competitive cost of hydrogen production by planning to locate and secure the highest quality, lowest cost, reliable
+local feedstock and the most appropriate technology for each of our development projects. 
+Generation Technology Agnostic 
+We plan to deploy a diverse network
+of equipment and technology suppliers, to produce hydrogen potentially utilizing steam methane reformers, alkaline electrolyzers, and
+proton exchange membrane (“PEM”) electrolyzers. Both alkaline and PEM electrolyzers use electricity to split water into hydrogen
+and oxygen gas molecules. However, the different systems use different electrolytes and membranes to separate the cathodes and anodes.
+PEMs produce hydrogen at a high purity, but are typically used on a smaller scale, while alkaline electrolyzers typically produce hydrogen
+on a large scale but lower purity hydrogen than PEM electrolyzers. National Renewable Energy Laboratory data indicates alkaline electrolyzers
+can reach greater than 99.3% purity and PEMs can reach greater than 99.9% purity. We plan to evaluate projects requiring hydrogen volumes
+of 100 normal cubic meters per hour (nm3h), roughly 400 to 500 kilowatts per hour, to 14,000 nm3h. We also intend to evaluate the production
+technology required on a project by project basis, and negotiate with our suppliers to size production capacity and plant, storage, compression
+and dispensing equipment and footprint appropriately to meet customer needs. 
+Feedstock Flexibility 
+As we are generation technology agnostic,
+we plan to work with both renewable and non-renewable feedstocks, including but not limited to anaerobic digester gas, landfill gas, pipeline-delivered
+biomethane, pipeline natural gas, liquid propane gas, and renewable or grid electricity. 
+Waste-to-Energy Focus 
+To lower both the carbon intensity
+and cost of the hydrogen we produce, we target waste feedstock for hydrogen production and existing CO2 emitters for CO2 recovery. 
+Distribution Diversity. We
+plan to sell hydrogen, CO2 and select other gases to industrial and hydrogen-as-an-energy-carrier customers that require high purity,
+reliable, cost-effective gas in bulk, dewar and cylinder volumes. We also plan to sell hydrogen generation and carbon dioxide recovery
+plants which are manufactured by our suppliers. 
+Single Input; Multiple Outputs 
+A key tenant of our growth strategy
+is to maximize the number of outputs we are able to achieve from a single feedstock input. We plan to evaluate and design projects to
+match the volumes of gases required by local offtake clients. Once a primary gas offtake and offtake customer have been identified, we
+plan to construct a full offtake plan for the project, taking into account the identified location of gas production, storage and dispensing,
+local feedstock availability, potential for additional local offtake customers of gases we could produce, and the local potential for
+merchant (spot) gas sales. We believe that all projects which successfully pass our design stage will typically support multiple gas output
+products. 
+Offtake/Merchant Mix 
+Designing projects with multiple outputs
+enables us to price gas we sell opportunistically, which we believe will enable us to achieve attractive end user pricing for both offtake
+(long term) and merchant (spot) customers. We believe our projects will typically have a target 70% or better offtake to merchant sales
+mix, and ideally all hydrogen produced would be sold on long-term contracts, — meaning, to successfully pass our project evaluation
+process for owned plants, we typically will have in hand, prior to approval of the project, letters of intent or customer commitments
+to purchase 70% or more of the project’s output. As such, for owned plants, Global Gas does not anticipate significant exposure
+to fluctuations in the market for hydrogen. 
+5 
+Low Lifecycle
+Carbon Intensity. We plan to design our projects so that the hydrogen we produce and CO2 we recover will have as low a
+lifecycle carbon intensity as practical. We believe that some of our future projects, from feedstocks such as wastewater, will
+produce hydrogen with neutral or negative carbon intensity. 
+● 
+The above chart reflects analysis by Global Gas based upon IEA, Rocky Mountain Institute, Princeton University, Hydrogen Council and International Council on Clean Transportation data. 
+Co-Location 
+Our strategy is
+to co-locate our hydrogen generation and carbon dioxide recovery plants as close to or even on-site with storage, compression and dispensing/refueling
+assets so that distribution costs are minimized or eliminated. We intend to select small, modular generation and recovery equipment manufactured
+by our suppliers for our projects so that we can place our “Gen/Fill” systems close to population centers where low-carbon
+clean hydrogen fuel and CO2 are most needed, and where CO2 recovery and capture is most beneficial. 
+6 
+Recovery and Reuse 
+Co-locating our
+Gen/Fill systems near existing CO2 emitters and population centers has the added advantage of increasing our ability to recover and reuse
+anthropogenic waste as source feedstock for the generation of the gases we sell. 
+Suppliers 
+We source equipment,
+components, and parts from a global network of specialized industrial suppliers. Suppliers are chosen to meet individual project and customer
+requirements, and are vetted based on performance, experience, and support. Global Gas’ electrolyzer and SMR equipment suppliers
+purchase raw materials and build components which are assembled into the hydrogen generation and carbon recovery plants, which we intend
+to co-locate, integrate, commission and start-up. Therefore, we are exposed, indirectly, to world prices for raw materials such as steel,
+nickel and other commodities, which are used in the components in our plants. We anticipate that our principal suppliers are equipment
+manufacturers, compressor manufacturers, and instrument suppliers such as Emerson, PDC Machines, and Unicat Catalysts. Global Gas may
+use the services of subcontractors to fabricate or manufacture portions or all of the unique and customer-specific hydrogen generation
+and carbon recovery equipment we sell to customers. Global Gas anticipates initially generating revenue through the sale of customer-specific
+hydrogen generation and carbon recovery equipment and solutions sold to customers. 
+Global Gas’ Competitive Strengths 
+Global Gas believes that
+other industrial gas suppliers of hydrogen target larger production capacities, which require greater amounts of feedstock, and their
+production facilities are often located in industrial clusters located far from population centers where gas for hydrogen-as-an-energy-carrier
+use cases are growing in prevalence. Projects which successfully pass our design stage are designed to exploit this opportunity: our projects
+will provide on-site or nearby Gen/Fill systems which dramatically reduce or eliminate distribution costs and we are able to use local,
+often waste, feedstock both to recover and reuse local waste, assist in reducing local CO2 emissions, and produce low carbon hydrogen,
+CO2, and other gases at economically attractive prices making fuel cell heavy duty transportation competitive with diesel. 
+Products & Services 
+Global Gas will primarily
+sell hydrogen, recovered CO2, and oxygen to offtake and merchant customers requiring gas for industrial and emerging hydrogen-as-an-energy-carrier
+use cases. We focus our selling efforts in North America, Western Europe and Great Britain, though we may consider opportunities outside
+of those geographies. We plan to design our projects to meet a wide range of customer requirements, including end use application, volume
+and type of gas required, location of gas need, redundancy requirements, budget, space available and other considerations. A project could
+have either hydrogen or CO2 as the primary offtake gas. We also may, selectively sell hydrogen generation, CO2 recovery, or other related
+equipment such as compressors and dispensers, when requested by our customers and manufactured by our suppliers. 
+We also plan to offer services
+related to the sale of our products. Depending on the product sold, these services could include professional services, plant commissioning
+and startup services, aftermarket spare parts, or plant operation services. 
+Human Capital Resources 
+As of April 15, 2026, Global
+Gas has two full-time employees, our Executive Chairman, Carter Glatt, and our Chief Operating Officer and Chief Financial Officer, Shachi
+Shah. Our human capital management objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating
+future employees. 
+Competition 
+We expect to generate revenue
+and income from the resale and leasing of systems and equipment, the resale of hydrogen gas purchased from other industrial suppliers,
+and the sale of value-added technical services such as: design, engineering and plant costing; project management; plant installation,
+plant commissioning, and plant startup; supervision of plant installation, plant commissioning and plant startup; and project structuring. 
+7 
+We compete with firms which
+manufacture, resell, and lease hydrogen equipment and infrastructure, and also with global industrial and regional gas suppliers who sell
+hydrogen, CO2 and air separation gases. 
+Competition in the systems
+and equipment and technical services business is based primarily on plant design and efficiency, quality of service, technical know-how,
+price, and delivery timelines, in addition to plant and equipment technology and performance guarantees. Competition in industrial gases
+is based primarily on price (absolute price and volatility of price), reliability of supply, ease of delivery, and end user application. 
+Customers 
+Our target customers are
+heavy duty fleet operators, owners of anaerobic digesters, landfills, renewable natural gas producers, other industrial gas distributors
+and traditional industrial chemical users of hydrogen. 
+Facilities 
+Our headquarters are located
+in West Palm Beach, Florida. We believe our current facilities are adequate for our current operating needs. 
+Corporate History 
+On December 21, 2023 (the
+“Closing Date”), the Company, a Delaware corporation (formerly known as Dune Acquisition Corporation) (prior to the Effective
+Time (as defined below), “Dune”), consummated the previously-announced business combination (“Business Combination”)
+pursuant to that certain Unit Purchase Agreement, dated May 14, 2023 (as amended on August 22, 2023 and as further amended on November
+24, 2023, the “Purchase Agreement”), by and among Dune, Holdings, a Delaware limited liability company and direct, wholly-owned
+subsidiary of Dune, Global Hydrogen, a Delaware limited liability company, and William Bennett Nance, Jr., Sergio Martinez and Barbara
+Guay Martinez (collectively, the “Sellers”), the equity holders of Global Hydrogen. 
+In connection with the closing
+of the Business Combination, Dune changed its name from Dune Acquisition Corporation to Global Gas Corporation, and on December 22, 2023,
+the Company’s Class A Common Stock (as defined below) and warrants began trading on Nasdaq under the new trading symbols “HGAS”
+and “HGASW,” respectively. 
+In accordance with the terms
+and subject to the conditions of the Purchase Agreement and the other transactions contemplated thereby, at the closing of the Business
+Combination (the “Closing”), (a) Dune contributed to Holdings all of its assets (excluding its interests in Holdings and the
+aggregate amount of cash proceeds required to satisfy redemptions by Dune’s public stockholders (“Stockholder Redemptions”)),
+and in exchange therefor, Holdings issued to Dune a number of common equity units of Holdings (“Holdings Common Units”) which
+equal the number of total shares of Class A common stock, par value $0.0001 per share (“Class A Common Stock”), of Dune issued
+and outstanding immediately after the Closing (giving effect to all Stockholder Redemptions) (such transactions, the “SPAC Contribution”)
+and (b) immediately after the SPAC Contribution, the Sellers transferred, conveyed, assigned and delivered all of the limited liability
+company equity interests of Global Hydrogen (“Global Hydrogen Units”) to Holdings in exchange for shares of Class B voting
+non-economic common stock, par value $0.0001 per share (“Class B Common Stock”), of Dune and Holdings Common Units (together
+with the SPAC Contribution, the “Combination Transactions”), as a result of which, (i) each issued and outstanding Global
+Hydrogen Unit immediately prior to the Combination Transactions is now held by Holdings, (ii) each Seller received an aggregate number
+of Holdings Common Units and shares of Class B Common Stock, in each case, equal to the number of Global Hydrogen Units held by such Seller,
+multiplied by the applicable exchange ratio, and (iii) Dune changed its name to Global Gas Corporation and the Company became the publicly
+traded reporting company. The effective time of the Business Combination on the Closing Date is referred to herein as the “Effective
+Time.” 
+8 
+The Business Combination
+was accomplished through what is commonly referred to as an “Up-C” structure, which is often used by partnerships and limited
+liability companies undertaking an initial public offering. The “Up-C” structure allowed the Sellers, who became equity holders
+of Holdings upon the consummation of the Combination Transactions, to retain their equity ownership in Holdings, an entity that is classified
+as a partnership for United States federal income tax purposes, in the form of Holdings Common Units after the Closing, and provides potential
+future tax benefits for both the Company and Holdings’ equity holders (other than the Company) after the Closing when they ultimately
+exchange their Holdings Common Units. 
+In accordance with the terms
+and subject to the conditions of the Purchase Agreement, at the Closing, the issued and outstanding Global Hydrogen Units of each Seller
+were transferred, conveyed, assigned and delivered in exchange for (i) a number of shares of Class B Common Stock equal to the product
+of (x) the number of Global Hydrogen Units held by such Seller and (y) the exchange ratio determined by dividing (A) the quotient of $43,000,000
+divided by the number of Global Hydrogen Units issued and outstanding immediately prior to the Closing by (B) $10.00 per share and (ii)
+a number of Holdings Common Units equal to the number of shares of Class B Common Stock received by such Seller pursuant to clause (i)
+hereof. 
+In connection with the Business
+Combination, on December 1, 2023, Dune and Global Hydrogen entered into a forward purchase agreement (the “Forward Purchase Agreement”)
+with each of Meteora Strategic Capital, LLC (“MSC”), Meteora Capital Partners, LP (“MCP”) and Meteora Select Trading
+Opportunities Master, LP (“MSTO” and, collectively with MSC and MCP, the “Meteora Entities”) for an OTC Equity
+Prepaid Forward Transaction. In connection with the Forward Purchase Agreement, Dune entered into a subscription agreement (the “Subscription
+Agreement”) with the Meteora Entities. Pursuant to the Subscription Agreement, the Meteora Entities agreed to subscribe for and
+purchase, and Dune agreed to issue and sell to the Meteora Entities, on the Closing Date, 681,220 shares of Class A Common Stock in the
+aggregate (the “PIPE Shares”). Pursuant to the Subscription Agreement, the Company gave certain registration rights to the
+Meteora Entities with respect to the PIPE Shares. The sale of the PIPE Shares was consummated concurrently with the Closing. 
+The rights of holders of
+our Class A Common Stock and Warrants are governed by our second amended and restated certificate of incorporation (the “Amended
+and Restated Charter”), our amended and restated bylaws (the “Amended and Restated Bylaws”) and the Delaware General
+Corporation Law (the “DGCL”), and in the case of our outstanding warrants, the Warrant Agreement dated as of December 17,
+2020, between the Company and Continental Stock Transfer & Trust Company (“Continental”), as warrant agent. 
+On June 21, 2024, due to
+the Company’s failure to satisfy the initial listing standards of The Nasdaq Capital Market upon closing of the Company’s
+previously announced business combination in accordance with Nasdaq Rule 5101-2 and specifically, the Company’s inability to demonstrate
+compliance with the Stockholders Equity, Publicly Held Shares, Market Value of Listed Securities and Market Value of Publicly Held Shares
+requirements set forth in Nasdaq Rule 5505, the Company received notice that the Panel had determined to delist the Company’s securities
+from Nasdaq and would suspend trading in its securities on the exchange effective at the open of business on June 25, 2024. Since the
+delisting, the Company’s common stock and warrants have been trading on the OTCQB with trading symbols “HGAS” and “HGASW”,
+respectively. 
+On March 4, 2024, the Company
+entered into forfeiture agreements (the “Forfeiture Agreements”) with certain holders of the Company’s Class B common
+stock. Pursuant to the Forfeiture Agreements, such holders forfeited an aggregate of 1,600,000 shares (the “Forfeited Shares”)
+in exchange for consideration previously received. On August 19, 2025, the Company entered into a settlement agreement (the “Settlement
+Agreements”) with certain holders of the Company’s Class B common stock. Pursuant to the Settlement Agreement, such holders
+forfeited an aggregate of 2,700,000 shares (the “Additional Forfeited Shares”) in exchange for consideration previously received.
+After the forfeitures of the Forfeited Shares and the Additional Forfeited Shares pursuant to the Forfeiture Agreements and the Settlement
+Agreement, there were no outstanding shares of the Company’s Class B common stock. 
+Additional Information About the Company 
+We maintain our website at
+hgas.co. The corporate filings of Global Gas, including our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our
+Current Reports on Form 8-K, our proxy statements and reports filed by our executive officers and directors under Section 16(a) of the
+Securities Exchange Act, and any amendments to those filings, are available free of charge on our website, which are uploaded as soon
+as reasonably practicable after we electronically file (or furnish in certain cases) such material with the Securities and Exchange Commission,
+and can also be found at the SEC’s website at http://sec.gov. We do not intend for any information contained in our website to be
+a part of this Annual Report. 
+9

raw/filings/0001817232/2025/0001213900-26-044164/item13.txt

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+Item 13. 
+Certain Relationships and Related Transactions, and Director Independence 
+45

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raw/filings/0001817241/2024/0000950170-25-043837/item1.txt

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+Item 1. 
+Business 
+1

raw/filings/0001817241/2024/0000950170-25-043837/item13.txt

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+Certain Relationships and Related Transactions, and Director Independence 
+147

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+Item 1. 
+Business 
+1

raw/filings/0001817241/2025/0001193125-26-100135/item13.txt

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+Item 13. 
+Certain Relationships and Related Transactions, and Director Independence 
+141