Owlet Transforms Infant Care with the Launch of Two FDA-Cleared Devices – Dream Sock® and BabySat™

Rhea-AI Summary

Owlet, Inc. (NYSE:OWLT) announces the launch of Dream Sock and BabySat, two FDA-cleared medical devices for at-home infant monitoring. The devices provide real-time health insights with medical-grade accuracy and aim to help parents monitor their baby's well-being. Dream Sock is a pulse oximetry solution for infants without the need for a prescription, while BabySat is intended for infants with acute or chronic medical conditions. Both devices offer caregivers the ability to track vital signs and receive real-time notifications for low pulse rate and low oxygen levels.

Insights

Medical Device Analyst

The recent FDA clearance of Owlet's Dream Sock and BabySat represents a significant milestone in the field of at-home infant care technology. The approval not only validates the medical-grade accuracy of these devices but also underscores the growing trend of consumer health technology moving into the regulatory realm, which traditionally has been reserved for professional healthcare devices.

From an industry perspective, Owlet's ability to secure FDA clearance for its products could potentially disrupt the market by setting new benchmarks for competitors. This is particularly relevant in the context of medical device regulations, which are stringent to ensure patient safety. The rigorous testing in hospital and home environments, as mentioned, indicates a high standard of product development and quality assurance that other market players will need to match or exceed.

Moreover, the insurance reimbursement eligibility for BabySat could lead to increased adoption rates and market penetration, as cost barriers are lowered for consumers. This move could also stimulate the overall market growth for smart infant monitoring systems, encouraging innovation and competition within the sector.

Healthcare Economist

The introduction of Owlet's FDA-cleared devices into the market has implications for healthcare economics, particularly in terms of potential cost savings and resource allocation. By providing parents with tools to monitor their infants' vital signs at home, these devices could reduce the need for emergency care visits and outpatient visits for conditions like RSV, which are mentioned to have high incidence rates.

Reducing hospital visits not only alleviates the burden on healthcare systems but also can lead to considerable cost savings for both families and insurers. This is especially pertinent given the statistics cited regarding the millions of emergency care visits and outpatient visits for infants annually. By potentially decreasing these numbers, Owlet's technology could contribute to more efficient use of healthcare resources and better allocation of medical personnel.

Furthermore, the ability of these devices to provide real-time health insights could lead to earlier interventions and improved health outcomes for infants, which in the long run may contribute to a decrease in healthcare expenditures associated with more severe health complications.

Pediatric Healthcare Specialist

The clinical impact of Owlet's Dream Sock and BabySat devices on pediatric healthcare should be considered. The real-time monitoring capabilities of these devices for vital signs such as pulse rate and oxygen saturation can be crucial for early detection of potential health issues in infants. The mention of clinically proven accuracy is a key factor in their potential to be integrated into standard pediatric care practices.

For infants with acute or chronic medical conditions, the ability to customize alarms and track live vital signs could enhance the quality of care by allowing for immediate response to critical health changes. This is particularly important given the statistic of a 40% decrease in mortality rates with the use of in-home pulse oximetry monitoring for complex congenital heart disease in infants.

Additionally, the ease of use and non-invasive nature of a wire-free sock design could lead to higher compliance rates among caregivers, ensuring consistent monitoring and data collection. This could ultimately contribute to better-informed clinical decisions and more personalized care plans for infants with health conditions.

These new, innovative devices empower caregivers to monitor what matters most with reliable, medical-grade technology.

LEHI, Utah--(BUSINESS WIRE)-- Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, today announces the launch and availability of Dream Sock^® and BabySat^™, two medical devices with recent clearances from the U.S. Food and Drug Administration (“FDA”). Both innovations deliver real-time health insights with medical-grade accuracy and unprecedented advancements for at-home infant care.

“We are on a mission to help parents monitor what matters most and are proud to now offer two FDA-cleared, at-home infant monitors to countless parents who want and need more information on their baby’s well-being,” said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. “Both the FDA-cleared Dream Sock and BabySat devices are a representation of our endless commitment to providing clarity and peace of mind for parents, while also setting new standards in the industry of infant care.”

According to a survey, parents lose a staggering 133 nights of sleep during the first year of their newborn’s life¹. Additionally, parents will experience more than three million emergency care visits for their infants each year², and, annually, more than two million children under the age of five have outpatient visits for respiratory syncytial virus (“RSV”)³. Dream Sock and BabySat are designed to arm caregivers with the tools to combat these common stressors – being clinically proven to accurately track and display an infant’s vital signs and notify parents in real-time so they can take action if required.

FDA-Cleared Dream Sock

Since achieving its De Novo clearance from the FDA in November 2023, Dream Sock continues to be the first-of-its-kind medical pulse oximetry solution for infants without the need for a prescription. Rigorously tested in both hospital and at-home environments and found to be compliant with all relevant performance and safety standards, the Dream Sock device provides accurate and actionable data to parents.

“Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers,” said Dr. Alisa Niksch, Pediatric Cardiologist and Senior Director of Medical Affairs at Owlet. “This device will equip parents of otherwise healthy babies with the real-time data they need to make informed care decisions for their infants. Owlet is dedicated to advancing the capabilities of Dream Sock to enhance care for infants in the home.”

Caregivers of healthy babies between 1-18 months and 6-30 lbs can now track their infant’s Live Health Readings, including pulse rate and oxygen saturation level, in the Owlet Dream App (iOS & Android), as well as receive real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen. These features are available to both existing and new Dream Sock users who opt to enable these features in the Dream App.

FDA-Cleared BabySat

The BabySat pulse oximetry monitoring system combines hospital-grade accuracy with Owlet’s modern and wire-free sock design, and is intended for infants between 1-18 months and 6-30 lbs with acute or chronic medical conditions. BabySat also provides the ability to track live vital signs, but is distinct from Owlet’s Dream Sock in that it is available through prescription only, and allows a healthcare provider to set and adjust customizable alarms for oxygen saturation and pulse rate that are tailored to an infant’s individual needs.

Research shows there is a 40% decrease in mortality rates with the use of in-home pulse oximetry monitoring to track oxygen saturation levels for complex congenital heart disease in infants⁴. The availability of the BabySat pulse oximeter for more vulnerable infant populations better connects healthcare providers and caregivers, and ultimately allows caregivers to more confidently care for their little ones at home. BabySat will also be eligible for insurance reimbursement, increasing affordability and further democratizing access to these advanced monitoring tools. Additional details on BabySat prescription, fulfillment, and insurance reimbursement will be announced soon.

“The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital,” said Jim Fidacaro, Owlet Senior Vice President and General Manager of Healthcare. “It extends medical-grade, personalized infant care to the home environment, and with oversight from a physician, parents of babies with health conditions can feel more in control of their little one’s well-being.”

Owlet is committed to offering products that set a new standard in infant care, combining advanced technology with ease of use to help caregivers have increased peace of mind while monitoring what matters most. For more details on each device and to find out which product is the right choice for your family, visit www.owletcare.com.

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 growth prospects, expanded product offerings and the impacts of the Company’s new FDA-cleared medical devices. 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 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; (ii) Owlet’s competition and the Company’s ability to profitably grow and manage growth; (iii) the Company’s ability to enhance future operating and financial results or obtain additional financing to continue as a going concern; (iv) 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; (v) 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; (vi) 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; (vii) Owlet’s ability to maintain relationships with customers, manufacturers and suppliers and retain Owlet’s management and key employees; (viii) Owlet’s ability to upgrade and maintain its information technology systems; (ix) changes in applicable laws or regulations; (x) 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; (xi) 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 (xii) 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, 2022, as updated in the Company’s Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2023, June 30, 2023 and September 30, 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.

References:
1.		https://www.snuz.co.uk/sleep-centre/news/the-truth-about-sleep-snuz-sleep-survey-results/
2.		https://www.ncbi.nlm.nih.gov/books/NBK526418/
3.		https://www.cdc.gov/rsv/research/index.html
4.		https://www.ahajournals.org/doi/10.1161/JAHA.119.014548

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240108878830/en/

Media Contacts:

pr@owletcare.com

owlet@diffusionpr.com

Source: Owlet, Inc.

FAQ

What is the company name and ticker symbol for the launch of Dream Sock and BabySat?

The company is Owlet, Inc. and the ticker symbol is OWLT.

What are the key features of Dream Sock and BabySat?

Dream Sock is a pulse oximetry solution for infants without the need for a prescription, providing real-time health insights with medical-grade accuracy. BabySat is intended for infants with acute or chronic medical conditions and offers the ability to track vital signs and receive real-time notifications for low pulse rate and low oxygen levels.

What age and weight range are the devices suitable for?

Both Dream Sock and BabySat are suitable for infants between 1-18 months and 6-30 lbs.

What are the benefits of using Dream Sock and BabySat for caregivers?

The devices empower caregivers to monitor infant health with reliable, medical-grade technology, providing real-time health insights and notifications for low pulse rate and low oxygen levels.

How can caregivers track vital signs using Dream Sock and BabySat?

Caregivers can track vital signs, including pulse rate and oxygen saturation level, through the Owlet Dream App (iOS & Android) and receive real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen.

What is the significance of the FDA clearances for Dream Sock and BabySat?

The FDA clearances validate the medical-grade accuracy and safety standards of both devices, providing parents with actionable data to make informed care decisions for their infants.

What is the availability of BabySat for vulnerable infant populations?

BabySat is intended for infants with acute or chronic medical conditions and is eligible for insurance reimbursement, increasing affordability and democratizing access to advanced monitoring tools.

Where can more details about Dream Sock and BabySat be found?

For more details on each device and to find out which product is the right choice for your family, visit www.owletcare.com.