Nemaura to Launch New Digital Brand proBEAT™ in the USA, Targeting a Market of Over 100 Million Potential Users With Its Pr...
March 30 2020 - 08:30AM
Business Wire
Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the
“Company”), a medical technology company focused on developing
micro-systems-based wearable diagnostic devices and digital
solutions for the medical and consumer markets, announced it is
planning to launch a digital healthcare subscription service in the
USA under the brand name proBEAT™.
proBEAT™ is expected to be available without the need for a
prescription and appeal to a broad range of adults encompassing
pre-diabetic and Type 2 diabetics, numbering 88 million, and 26
million people respectively1, as well as those seeking to lose
weight and/or seeking a healthier lifestyle.
proBEAT™ is expected to help users improve their knowledge of
how a range of lifestyle, dietary and health and wellbeing factors
impact their sugar levels by acting like a black box flight
recorder. Big data about the multitude of factors that affect
glucose levels will be gathered from all users and employed in
developing and subsequently ‘fine-tuning’ predictive algorithms and
artificial intelligence based feedback and prompts. These will then
be able to both educate and provide motivational tools to the user
to encourage them to lead a healthier lifestyle.
Nemaura is now prioritizing launch plans for its proBEAT™
digital health platform in the U.S. and is considering various
options to expedite the launch, including potential partnering with
multi-national companies.
Nemaura intends to market this device as a general wellness
product as described in the FDA’s guidance document on the subject.
General Wellness Products outlined in current FDA guidance are
those which have either: (1) An intended use that relates to
maintaining or encouraging a general state of health or a healthy
activity, or (2) an intended use that relates the role of healthy
lifestyle with helping to reduce the risk or impact of certain
chronic diseases or disease conditions and where it is well
understood and accepted that healthy lifestyle choices may play an
important role in health outcomes for the disease or condition2.
Further details are provided on Nemaura’s website:
https://nemauramedical.com/wp-content/uploads/2020/03/NMRD-Welness-PDF-Final-30Mar2020.pdf
1 American Diabetes Association 2 General Wellness: Policy for
Low Risk Devices – Guidance for Industry and Food and Drug
Administration Staff (September 27, 2019)
About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company
developing micro-systems-based wearable diagnostic devices and
currently commercializing sugarBEAT™, and proBEAT™. sugarBEAT®, a
CE mark approved Class IIb medical device, is a non-invasive and
flexible continuous glucose monitor (CGM) providing actionable
insights derived from real time glucose measurements and daily
glucose trend data, which may help people with diabetes and
pre-diabetes to better manage, reverse and prevent the onset of
diabetes. Nemaura is planning to submit a PMA application for
sugarBEAT® during the second quarter of 2020 for FDA review of this
device under medical device regulations. proBEAT™ comprises a
non-invasive glucose monitor and a digital healthcare subscription
service and is due to be launched in the US as a general wellness
product.
For more information visit: www.NemauraMedical.com.
Cautionary Statement Regarding Forward-Looking Statements: The
statements in this press release that are not historical facts may
constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, the launch of
proBEAT® in the US, risks related to regulatory status and the
failure of future development and preliminary marketing efforts,
Nemaura’s ability to secure additional commercial partnering
arrangements, risks and uncertainties relating to Nemaura and its
partners’ ability to develop, market and sell proBEAT®, the
availability of substantial additional equity or debt capital to
support its research, development and product commercialization
activities, and the success of its research, development,
regulatory approval, marketing and distribution plans and
strategies, including those plans and strategies related to both
proBEAT® digital health, and sugarBEAT®. There can be no assurance
that the company will be able to reach a part of or any of the
global market for CGM with its products/services. The FDA reserves
the right to re-evaluate their decision that proBEAT® qualifies as
a general wellness product should it become aware of any issues
such as skin irritation or other adverse events from the device, as
well as any misuse impacting patient safety, and any other reason
as the FDA may see fit at its discretion to determine the product
does not fit the definition of a general wellness product. These
and other risks and uncertainties are identified and described in
more detail in Nemaura’s filings with the United States Securities
and Exchange Commission, including, without limitation, its Annual
Report on Form 10-K for the most recently completed fiscal year,
its Quarterly Reports on Form 10-Q, and its Current Reports on Form
8-K. Nemaura undertakes no obligation to publicly update or revise
any forward-looking statements.
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Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498
dave@redchip.com
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