Owlet, Inc. (NYSE: OWLT) (the “Company” or “Owlet”), the pioneer
of smart infant monitoring, announces De Novo clearance from the
U.S. Food and Drug Administration (“FDA”) of Dream Sock, the first
and only over-the-counter medical pulse oximetry solution for
infants. Owlet is spearheading new standards for consumer and
medical solutions, allowing caregivers to provide better care at
home for their babies through access to advanced digital health
technologies.
The FDA-cleared Dream Sock will monitor and display Baby’s Live
Health Readings, including pulse rate and oxygen saturation level,
and will provide Health Notifications, which will alert caregivers
with lights and alarm sounds if their infant’s readings fall
outside of preset ranges. Owlet plans to make these new
medical-grade features available to all existing and new Dream Sock
users upon launch, soon to be announced. These cleared features are
for use with healthy infants between 1-18 months and 6 lbs to 30
lbs.
“Today marks a significant breakthrough in our journey to bring
care to the home and empower parents with an unprecedented
FDA-clearance for the Owlet Dream Sock,” said Kurt Workman, Owlet
Chief Executive Officer and Co-Founder. “This accomplishment not
only signifies our commitment to innovation in the infant health
category but, more importantly, our dedication to ensuring the
health and well-being of every baby. With this De Novo clearance,
we are proud to set new standards in at-home infant care, arming
parents with reliable real-time information and providing enhanced
peace of mind.”
Achieving De Novo clearance means the Owlet Dream Sock was
clinically tested in both home and hospital environments, and
proven to be as accurate as medical-grade baby monitoring
technology and compliant with all relevant performance and safety
standards by independent laboratories. This new technology will
equip caregivers with the right information at the right time, and
provide them with confidence and clarity on their baby’s
well-being.
“We’re all so proud that the Dream Sock was validated against
the gold standards of accuracy for pulse oximetry devices – and
stood up to that challenge,” said Dr. Alisa Niksch, Pediatric
Cardiologist and Senior Director Medical Affairs at Owlet.
“Throughout this process, we learned a tremendous amount about the
capabilities of our product in supporting the care of babies in the
home. We're excited to continue our research efforts as we bring
new technologies and advancements in accuracy in infant monitoring
to parents.”
This follows the Company’s previous FDA clearance of BabySat™, a
prescription monitoring system that uses pulse oximetry technology
and features a modern, wire-free sock design. Intended for infants
with acute or chronic medical conditions under the supervision of a
physician, BabySat provides a real-time display of a baby’s pulse
rate and oxygen saturation level, and alerts parents when these
customizable readings fall outside of prescribed ranges. BabySat
will be available for purchase with insurance reimbursement soon.
Now, Owlet’s clinically-validated technology and notification
algorithms are available for use with healthy babies without a
prescription.
These new FDA-cleared features will begin rolling out to both
existing and new Dream Sock users by the end of this year, in the
U.S. only. Parents and caregivers can learn more and sign up to
receive the latest information and details on product availability
at www.owletcare.com/fda-clearance.
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.
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Media: pr@owletcare.com
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