Owlet Announces European Medical Certification of Dream SockⓇ

May 02, 2024 at 08:37 AM EDT

Parents will soon have access to Owlet’s Dream Sock with medically-certified CE-Marking across the European markets

Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), the pioneer of smart infant monitoring, announces the EU medical device certification of Dream Sock. This EU-CE-Mark certification, issued by Owlet’s EU notified body, signifies that Owlet’s Dream Sock has been assessed and certified to meet safety and health requirements set out under EU medical device legislation. With this certification, Owlet plans to expand its medical-device product portfolio to even more caregivers around the world.

This EU medical device certification follows two marketing authorizations from the U.S. Food and Drug Administration (the “FDA”), for Dream Sock, with new medical technology for healthy infants over-the-counter without a prescription, and for BabySat^Ⓡ, a prescription-only pulse oximeter designed for use with babies that have a pre-existing medical condition.

“Our mission to be there for every parent and every baby becomes even more realized with the European medical certification for Dream Sock,” said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. “Parents throughout Europe will soon have access to the most innovative, consumer-friendly, medical-grade, smart baby monitoring technology so they can be more empowered to provide care from the comfort of their homes.”

Dream Sock comfortably wraps around a baby's foot and is intended for routine, in-home surveillance of healthy infants by measuring oxygen saturation and pulse rate, and will provide sleep insights for parents that are new for the European markets. Its advanced technology offers clinically-proven accuracy, while the connected Owlet Dream App delivers live readings directly to a mobile device and a nearby Base Station – both of which can provide a notification to the caregiver, prompting them to assess the infant. Dream Sock, as certified for the EU, is intended for use with healthy infants between 0-18 months and 2.5-13.6 kg. Its notifications and associated data are intended to supplement the decision by caregivers to seek additional guidance for medical care of the infant. It is not intended to replace traditional methods of diagnosis and/or treatment.

While not currently available for sale, Dream Sock is expected to launch throughout Germany, France and the UK this spring, with other European countries to follow.

About Owlet, Inc.

Owlet was founded by a team of parents in 2012. Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident. Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. Owlet also believes that every child deserves to live a long, happy, and healthy life, and is working to develop products to help further that belief. To learn more, visit www.owletcare.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s certification of its Dream Sock in the EEA and the impacts, growth prospects, and expanded product offerings and product availability in international markets. In some cases, you can identify forward-looking statements by terms such as “estimate,” “may,” “believes,” “plans,” “expects,” “anticipates,” “intends,” “goal,” “potential,” “upcoming,” “outlook,” “guidance,” the negation thereof, or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on the Company’s expectations at the time such statements are made, speak only as of the dates they are made and are susceptible to a number of risks, uncertainties and other factors. For all such forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. The Company’s actual results, performance or achievements may differ materially from any future results, performance or achievements expressed or implied by our forward-looking statements. Many important factors could affect the Company’s future results and cause those results to differ materially from those expressed in or implied by the Company’s forward-looking statements. Such factors include, but are not limited to, (i) the availability of, adoption and commercial success of Dream Sock and its new medical technology within these international markets, (ii) the regulatory pathway for Owlet’s products, including submissions to, actions taken by and decisions and responses from regulators, such as the FDA and similar regulators outside of the United States, as well as Owlet’s ability to obtain and maintain regulatory approval or certification for our products and other regulatory requirements and legal proceedings; (iii) Owlet’s competition and the Company’s ability to profitably grow and manage growth; (iv) the Company’s ability to enhance future operating and financial results or obtain additional financing to continue as a going concern; (v) Owlet’s ability to obtain additional financing in the future, as well risks associated with the Company’s current loan and debt agreements, including compliance with debt covenants, restrictions on the Company’s access to capital, the impact of the Company’s overall debt levels and the Company’s ability to generate sufficient future cash flows to meet Owlet’s debt service obligations and operate Owlet’s business; (vi) the ability of Owlet to implement strategic initiatives, reduce costs, grow revenues, develop and launch new products, innovate and enhance existing products, meet customer demands and adapt to changes in consumer preferences and retail trends; (vii) Owlet’s ability to acquire, defend and protect its intellectual property and satisfy regulatory requirements, including but not limited to requirements concerning privacy and data protection, breaches and loss, as well as other risks associated with Owlet’s digital platforms and technologies; (viii) Owlet’s ability to maintain relationships with customers, manufacturers and suppliers and retain Owlet’s management and key employees; (ix) Owlet’s ability to upgrade and maintain its information technology systems; (x) changes in applicable laws or regulations; (xi) the impact of and disruption to Owlet’s business, financial condition, operations, supply chain and logistics due to economic and other conditions beyond the Company’s control, such as health epidemics or pandemics, macro-economic uncertainties, social unrest, hostilities, natural disasters or other catastrophic events; (xii) the possibility that Owlet may be adversely affected by other economic, business, regulatory, competitive or other factors, such as changes in discretionary consumer spending and consumer preferences; and (xiii) other risks and uncertainties set forth in the Company’s other releases, public statements and filings with the U.S. Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and as any such factors may be updated from time to time in the Company’s other filings with the SEC. All such forward-looking statements attributable to the Company or any person acting on the Company’s behalf are expressly qualified in their entirety by the cautionary statements contained or referred to above. Moreover, the Company operates in an evolving environment. New risk factors and uncertainties may emerge from time to time, and factors that the Company currently deems immaterial may become material, and it is impossible for the Company to predict such events or how they may affect Owlet. Except as required by law, the Company assumes no obligation to update any forward-looking statements after the date of this press release, whether because of new information, future events or otherwise, although Owlet may do so from time to time. The Company does not endorse any projections regarding future performance that may be made by third parties.