Nemaura Medical 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 recognises 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 US, 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.
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.