Parents in the United Kingdom will soon have
access to Owlet’s Dream Sock with UKCA certification
Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer
of smart infant monitoring, has received UK medical device
certification, following the recent achievement of CE Mark
certification. This marks a significant milestone for Owlet, moving
the company forward in its mission to increase access to
medical-grade infant monitoring technology to parents and
caregivers around the world.
The UKCA certification, granted by a recognized UK-approved
body, follows the recent announcement of Owlet’s EU CE mark
certification of Dream Sock earlier this month and now provides
Owlet with medical device certifications in key UK and European
markets where its distribution partners operate. These
certifications also follow the Company’s 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.
“With the addition of the UKCA certification, Owlet is now able
to increase its reach throughout the European market, where more
than 3.8 million babies are born each year1. This represents a
significant opportunity for Owlet to expand its business and reach
more families with its innovative baby monitoring products,” said
Jonathan Harris, Owlet President and Chief Revenue Officer. “Owlet
is extremely well-positioned to take advantage of both the UKCA and
EU medical certifications with key retail partnerships across the
European market. These partnerships will allow the Company to reach
a wider range of consumers and make its products more accessible to
families in the region.”
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 UK market. 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 UK, 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.
Owlet’s Dream Sock is expected to launch at major retailers in
the UK, Germany, and France in the coming months, with other
European countries to follow later this summer at
www.owletbabycare.co.uk and Amazon in select markets.
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 of its
Dream Sock in the UK 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 the Company can't 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://ec.europa.eu/eurostat/web/products-eurostat-news/w/ddn-20240307-1#:~:text=In%202022%2C%203.88%20million%20babies,4.68%20million%20children%20were%20born.
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version on businesswire.com: https://www.businesswire.com/news/home/20240514932514/en/
Media: pr@owletcare.com owlet@diffusionpr.com
Grafico Azioni Sandbridge Aquisition (NYSE:OWLT)
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Grafico Azioni Sandbridge Aquisition (NYSE:OWLT)
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Da Gen 2024 a Gen 2025
