Business Wire

UT-OWLET

3.9.2024 15:42:26 CEST | Business Wire | Press release

Share
Owlet Announces Expanded Availability of Medically-Certified Dream SockTM Across Europe

Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, announced today at Kind + Jugend in Cologne, Germany, that medically-certified Dream Sock will soon be available in even more countries, including Poland, Greece, and the Czech Republic. Dream Sock is the Company’s medically-certified baby monitor accessible across Europe, giving parents safe and accurate health readings and actionable alarms while their baby sleeps.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240903971490/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Owlet Dream Sock (Photo: Business Wire)

“Dream Sock has already made a huge impact on thousands of families since its global launch a few months ago, and we are eager to continue the roll-out of our medical-grade technology to even more parents,” said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. “We are attending Kind + Jugend this week to meet with current and potential distribution partners to demonstrate our latest technology and show the impact Owlet is having across the world.”

Dream Sock is CE and UKCA Marked under EU and UK Medical Device Regulations and meets rigorous regulatory standards, ensuring its safety, efficacy, and compliance with all applicable requirements. This smart digital health infant monitoring device comfortably wraps around Baby's foot, providing real-time monitoring of pulse rate, oxygen saturation level, sleep patterns, and more. The connected Owlet Dream App (available on iOS and Android) delivers live health readings directly to mobile devices and the included Base Station – both of which will immediately notify users if Baby has low/high pulse rate, or low oxygen. It is clinically proven to accurately track and display an infant’s vital signs and is intended for healthy infants between 0-18 months and 2.5-13.6 kg. Dream Sock can also be paired with the Owlet Cam® 2 allowing caregivers to see and hear Baby from anywhere, receive motion notifications, and more.

Dream Sock is available now for purchase in the UK and select European markets. Dream Sock will be available in the following markets via Owlet’s localized websites and key retailers in the coming weeks: Poland, the Czech Republic, Slovakia, Hungary, Romania, Bulgaria, and Greece.

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 2 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 its Dream Sock in the European Market 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 additional international markets, (ii) the regulatory pathway for the Company’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 the Company’s ability to obtain and maintain regulatory approval or certification for our products and other regulatory requirements and legal proceedings; (iii) any developments in litigation in which the Company is involved, including the Butala and Cherian cases described in the Company’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”); (iv) the ability of the Company to maintain listing of its Class A common stock on a national stock exchange, including by coming back into compliance with Section 802.01B of the NYSE Listed Company Manual within the allotted cure period described in the Company’s reports filed with the SEC; (v) the Company’s competition and the Company’s ability to profitably grow and manage growth; (vi) the Company’s ability to enhance future operating and financial results or obtain additional financing to continue as a going concern; (vii) 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 the Company’s debt service obligations and operate its business; (viii) the ability of the Company 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; (ix) the Company’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 the Company’s digital platforms and technologies; (x) the Company’s ability to maintain relationships with customers, manufacturers and suppliers and retain Owlet’s management and key employees; (xi) the Company’s ability to upgrade and maintain its information technology systems; (xii) changes in applicable laws or regulations; (xiii) the impact of and disruption to the Company’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; (xiv) the possibility that the Company may be adversely affected by other economic, business, regulatory, competitive or other factors, such as changes in discretionary consumer spending and consumer preferences; and (xv) other risks and uncertainties set forth in the Company’s other releases, public statements and filings with the 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, subsequent Quarterly Reports on Form 10-Q, and any current or periodic reports filed 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 the Company can't predict such events or how they may affect the Company. 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 the Company may do so from time to time. The Company does not endorse any projections regarding future performance that may be made by third parties.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240903971490/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release

A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us

Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release

Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas

ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release

OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future

Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release

Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority

Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release

Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye