Nemaura Medical Submits PMA Application for sugarBEAT® to U.S. FDA
July 07 2020 - 6:00AM
Business Wire
Company to Participate in RedChip Webinar on Tuesday, July 7,
at 11 a.m. ET to Discuss Commercialization Progress
Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the
“Company”), a medical technology company focused on developing
micro-systems-based wearable diagnostic devices and currently
commercializing sugarBEAT®, its non-invasive and flexible
continuous glucose monitor (“CGM”), together with BEAT™diabetes, a
planned health subscription service designed to help people with
Type 2 diabetes and prediabetes through personalized lifestyle
coaching, today announced it has submitted its PMA application for
sugarBEAT® to the United States Food and Drug Administration (FDA)
through the eCopy (electronic copy) program submission process.
Nemaura’s CEO, Dr. Faz Chowdhury, commented, “The USA represents
the largest single market for sugarBEAT® and submission of the PMA
application is a major milestone for the Company. Whilst the PMA
application is under review for approval of sugarBEAT® as a Class
III medical device, we plan to launch proBEAT™ in the USA later
this year. proBEATTM will be introduced as a wellbeing device
whereby we will be collecting glucose profiles and developing
artificial intelligence-based prompts and feedback on how different
factors affect glucose levels to help people make informed
lifestyle choices”.
The intended use of sugarBEAT® is for persons with diabetes as
an adjunct to finger prick testing to monitor and track their
glucose profiles, so that the user can be better informed about the
factors affecting their glucose profile, and to help manage their
diabetes or potentially reverse their diabetes in the case of Type
2 diabetes. sugarBEAT is targeted initially at the Type 2 diabetic
population, which number is greater than 25 million people in the
U.S.
Investor Webinar
CEO Dr. Faz Chowdhury will be participating in an investor
webinar, hosted by RedChip Companies, on Tuesday, July 7, 2020 at
11:00 a.m. ET. A live Q&A session with Dr. Chowdhury will
follow the presentation. During the presentation, Dr. Chowdhury
will provide an update on the Company’s developments, including
commercialization progress, U.S. product launch, and status of
collaborative partnerships, as well as update on a continuous
temperature monitor (CTM) for both the diabetes and non-diabetes
markets.
To register for the free webinar, please visit:
https://www.redchip.com/corporate/webinar_register/64
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 has also submitted a PMA application for
sugarBEAT® to the U.S. FDA. 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 U.S., 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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version on businesswire.com: https://www.businesswire.com/news/home/20200707005378/en/
Investor Contact: Dave Gentry, CEO RedChip Companies Office:
1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com
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