Nemaura Announces Completion of Key Stages of Technical File Review for SugarBEAT® CE Mark Approval
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today announced that two of the three key stages for the CE Mark approval of sugarBEAT® have been completed.
The CE review process was based on a Fast Track application made by Nemaura with their designated European Notified Body, BSI, a global leader in accreditation services.(1) This allowed the technology review to be conducted on-site, which was successfully completed in September 2018. The clinical review was conducted off site and completed in December 2018 after Nemaura provided responses to a first series of questions from the specialist Clinical Reviewer. The final stages of the review and clinician sign off are overdue and now expected to be completed in early 2019, after which Nemaura expects CE approval will be issued. A predecessor version of sugarBEAT®, based on a wrist watch form factor, received CE Mark approval in Q1 2016.
Notified bodies have been experiencing a surge in workload for a combination of reasons, including revision to guidelines of regulatory standard ISO13485:2016, for which all companies are required to comply with by 2019.
SugarBEAT® is first planned for launch in the UK, after receiving CE Mark approval, where the addressable market for CGM is valued at $1.38B. In anticipation of CE Mark approval, Nemaura has pre-ordered 12,500 sugarBEAT® transmitters and developed manufacturing capacity for approximately 100,000 patches per month. (2)
The global addressable market for CGM is estimated at $82B per annum, with the U.S. market estimated at $13B. CGM adoption amongst people with diabetes is minimal and growing rapidly, with the U.S. the largest single market with an estimated 2.6% (630,000 users) of all diagnosed diabetics using CGM in 2018, representing annualized growth of 117%.(3)
Dr. Faz Chowdhury, CEO of Nemaura, will host an investor webinar and live Q&A at 10am ET today. To view the webinar, please visit https://www.redchip.com/events/34/nemaura-medical-webinar.
To view a video of sugarBEAT®, please visit http://sugarbeat.com/introducing-sugarbeat/
3 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use sugarBEAT® when calibrated by a finger stick reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
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Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, and 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, risks related to regulatory approvals and the success of Nemaura Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical and its partners’ ability to develop, market and sell sugarBEAT®, 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 sugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura Medical’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Nemaura Medical Inc.
Chief Business Officer