Owlet® Achieves TGA Certification for Dream Sock™, Paving the Way for Launch in Australia and New Zealand
Certification underscores Owlet's commitment to bringing medically-certified infant monitoring technology to every family across the globe.
Owlet, Inc. ("Owlet" or the "Company") (NYSE:OWLT), the pioneer of smart infant monitoring, today announces that Dream Sock™ has received official certification from Australia's Therapeutic Goods Administration (TGA), meeting rigorous standards required for medical devices in the region.
"TGA certification of Dream Sock marks an important step forward in our global expansion, bringing more families worldwide access to the latest pediatric health monitoring technology," said Jonathan Harris, Owlet's President. "For parents in these markets, certification means they will soon have access to a trusted, medically-certified tool to support their baby's health and well-being."
Dream Sock is a wearable smart baby monitor, designed for healthy infants between 0-18 months or 2.5-13.6 kg, that tracks key health indicators such as pulse rate, oxygen level, and sleep patterns. The connected Owlet Dream App displays readings in real-time, and both the Dream App and the included Base Station provide notifications if measurements fall outside preset ranges.
Having monitored over two million babies globally, Owlet is expanding access to its newly certified medical device to give more families peace of mind. Dream Sock is expected to be available for purchase later this year in Australia and New Zealand through the Company's local website and retail partners, including Baby Bunting. Parents can sign up at www.owletcare.com.au to be notified when Dream Sock is available and learn more about Owlet.
About Owlet, Inc.
Owlet's digital health infant monitoring platform is transforming the journey of parenting. The Company (NYSE:OWLT), a small-cap healthcare growth equity, offers FDA-authorized medical and consumer pediatric wearables and an integrated HD visual and audio camera that provide real-time data and insights to parents who safeguard health, optimize wellness, and ensure peaceful sleep for their children.
Since 2012, over two million parents worldwide have used Owlet's platform, contributing to one of the largest collections of consumer infant health and sleep data. The Company continues to develop software and digital data solutions to bridge the current healthcare gap between hospital and home and bring new insights to parents and caregivers globally. Owlet believes that every child deserves to live a long, happy, and healthy life. 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 and launch of Dream Sock™ in Australia and New Zealand, and the related impacts, growth prospects, expanded product offerings and international availability. 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 its 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 in Australia, New Zealand and other 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 its 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 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; (v) Owlet's ability to acquire, defend and protect its intellectual property and satisfy regulatory requirements concerning privacy and data protection; (vi) Owlet's ability to maintain relationships with customers, manufacturers and suppliers; (vii) impacts from compliance with applicable laws or regulations; (viii) 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; (ix) adverse impacts from other economic, business, regulatory, competitive or other factors, such as changes in discretionary consumer spending and consumer preferences; and (x) 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, 2024, 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.
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