Parents will soon have access to Owlet’s Dream
Sock with medically-certified CE-Marking across the European
markets
Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer
of smart infant monitoring, announces the EU medical device
certification of Dream Sock. This EU-CE-Mark certification, issued
by Owlet’s EU notified body, signifies that Owlet’s Dream Sock has
been assessed and certified to meet safety and health requirements
set out under EU medical device legislation. With this
certification, Owlet plans to expand its medical-device product
portfolio to even more caregivers around the world.
This EU medical device certification follows two marketing
authorizations from the U.S. Food and Drug Administration (the
“FDA”), for Dream Sock, with new medical technology for healthy
infants over-the-counter without a prescription, and for BabySatⓇ,
a prescription-only pulse oximeter designed for use with babies
that have a pre-existing medical condition.
“Our mission to be there for every parent and every baby becomes
even more realized with the European medical certification for
Dream Sock,” said Kurt Workman, Owlet Chief Executive Officer and
Co-Founder. “Parents throughout Europe will soon have access to the
most innovative, consumer-friendly, medical-grade, smart baby
monitoring technology so they can be more empowered to provide care
from the comfort of their homes.”
Dream Sock comfortably wraps around a baby's foot and is
intended for routine, in-home surveillance of healthy infants by
measuring oxygen saturation and pulse rate, and will provide sleep
insights for parents that are new for the European markets. Its
advanced technology offers clinically-proven accuracy, while the
connected Owlet Dream App delivers live readings directly to a
mobile device and a nearby Base Station – both of which can provide
a notification to the caregiver, prompting them to assess the
infant. Dream Sock, as certified for the EU, is intended for use
with healthy infants between 0-18 months and 2.5-13.6 kg. Its
notifications and associated data are intended to supplement the
decision by caregivers to seek additional guidance for medical care
of the infant. It is not intended to replace traditional methods of
diagnosis and/or treatment.
While not currently available for sale, Dream Sock is expected
to launch throughout Germany, France and the UK this spring, with
other European countries to follow.
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 certification of its
Dream Sock in the EEA 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 these
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 our
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 Company’s ability to enhance
future operating and financial results or obtain additional
financing to continue as a going concern; (v) 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; (vi) 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; (vii) 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; (viii)
Owlet’s ability to maintain relationships with customers,
manufacturers and suppliers and retain Owlet’s management and key
employees; (ix) Owlet’s ability to upgrade and maintain its
information technology systems; (x) changes in applicable laws or
regulations; (xi) 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; (xii) 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 (xiii) 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, 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 owlet@diffusionpr.com
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