These new, innovative devices empower
caregivers to monitor what matters most with reliable,
medical-grade technology.
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
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version on businesswire.com: https://www.businesswire.com/news/home/20240108878830/en/
Media Contacts: pr@owletcare.com
owlet@diffusionpr.com
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