Nemaura Medical Announces Progress on Listing of sugarBEAT® For Reimbursement in Germany
May 06 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
announced progress with the German regulatory authority (GBA) to
achieve reimbursement for its sugarBEAT® device.
After initial review, the GBA has determined
that sugarBEAT does not require GBA review and will go directly to
the National Association of Statutory Health Insurance Funds
(GKV-Spitzenverband) for a listing on the durable medical catalog.
The Company is now completing the application for this listing,
which is expected to be faster than where a GBA review is required.
“The availability of SugarBEAT® in Germany would be an important
milestone for Nemaura and we are actively collaborating with the
appropriate agencies to ensure timely availability there,” said
Nemaura CEO Dr. Faz Chowdhury. “In the meantime, we are actively
negotiating to identify the right partner to market and distribute
the product and our program in this very important market. We will
continue to provide updates as appropriate on our
progress.”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 has been launched in the U.S. as a general wellness
product as part of its BEAT®diabetes program.
The Company believes that it 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 AbrahamCORE
IR917-885-7378julesa@coreir.com
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