Loughborough, England, March 11, 2021 (GLOBE NEWSWIRE) -- 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