Nemaura Medical Inc., a medical device company developing a minimally invasive, needle-free, wireless CGM (Continuous Glucose Monitoring) patch known as sugarBEAT, today announced that it has signed a letter of intent (LOI) with a Chinese corporation, Shenzen CAS Health Corporation Limited, which is a partially owned subsidiary of the Chinese Academy of Science.
The letter of intent covers three potential joint venture arrangements relating specifically to sugarBEAT including (a) setting up a joint venture company to distribute in China, (b) setting up a manufacturing facility in China and (c) obtaining CFDA approval. Nemaura Medical recognizes the size and importance of the Chinese market. As a result, the Company has prioritized obtaining CFDA regulatory approvals as the next step in fulfilling a primary objective under the LOI.
Nemaura Medical anticipates a sugarBEAT product launch in Europe in 2017, where it has previously obtained CE approval. In the U.S., Nemaura Medical has had discussions with the FDA and anticipates completing its clinical program and submitting a PMA application around mid 2017.
SugarBEAT differs from existing CGM’s given it comprises an adhesive daily-disposable skin-patch which does not require insertion of a needle-like sensor inside the skin. SugarBEAT also provides users with tremendous flexibility as to when and how often they choose to wear the patch. Both of these factors are expected to empower users in a way current CGM’s cannot.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT System as a minimally-invasive, needle-free, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
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’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT CGM System, 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 the sugarBEAT System, 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 its sugarBEAT System. These and other risks and uncertainties are identified and described in more detail in Nemaura’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 undertakes no obligation to publicly update or revise any forward-looking statements.