Nemaura Medical Announces Submission to German Authorities for Reimbursement of its Glucose Monitoring Device
March 11 2021 - 8:00AM
Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”),
a medical technology company focused on developing and
commercializing non-invasive wearable diagnostic devices and
supporting personalized lifestyle coaching programs, today
announces its submission to G-BA (Gemeinsamer Bundesausschuss) for
approval of sugarBEAT®, the Company’s non-invasive, daily wear,
continuous glucose monitoring device.
The G-BA is the highest decision-making body for
joint self-administration in the German health care system,
determining medical services that insured people can claim as well
as resolving quality assurance measures for practices and
hospitals. The G-BA’s primary function is specifying the “service
catalog” of the health insurance companies according to the
generally recognized state of medical knowledge. Should it be
approved for reimbursement, Nemaura would work with Germany’s
individual statutory health insurance organizations to determine
terms of reimbursement contracts. Dr. Fred Schaebsdau, Nemaura’s
Vice President of Strategy and Strategic Alliances is coordinating
the effort for the Company.
Faz Chowdhury, Ph.D., Nemaura’s CEO commented,
“With approximately 73 million insured people in
statutory/public sick funds in Germany, the
submission to the G-BA for our non-invasive glucose monitoring
device provides a significant opportunity for us to increase our
penetration in this market and drive future growth of our
sugarBEAT® product. There are currently 425 million people
around with world with diabetes resulting in a total addressable
market of over $150 billion for sugerBEAT. Gaining access to the
German market would mark a significant milestone in expanding
commercialization and increasing availability and use sugarBEAT®.
We look forward to working with the G-BA as we progress through
their approval process.”
About Nemaura Medical, Inc.
Nemaura Medical Inc. is a medical technology
company developing and commercializing non-invasive wearable
diagnostic devices. The company is 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 submitted a PMA
(Premarket Approval Application) for sugarBEAT® to the U.S. FDA.
proBEAT™ combines non-invasive glucose data processed using
artificial intelligence and a digital healthcare subscription
service and is commercially marketed in the US as part of the
BEATdiabetes program (BEATdiabetes.Life).
The Company sits at the intersection of the global Type 2
diabetes market that is expected to reach nearly $59 billion by
2025, the $50+ billion pre-diabetic market, and the wearable
health-tech sector for weight loss and wellness applications that
is estimated to reach $60 billion by 2023.
For more information, please 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.
Contact:
Jules Abraham CORE IR 917-885-7378 julesa@coreir.com
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