Through the deal, the companies aim to establish a joint venture company to distribute its sugarBEAT CGM system in China, a manufacturing facility in China and Chinese FDA approval for the device.
Nemaura’s sugarBEAT CGM is designed as a wearable sensor patch which transmits data via bluetooth to provide real time glucose readings on a standalone reader, smart watch or smart phone app, the company said.
U.K.-based Nemaura has “prioritized obtaining CFDA regulatory approval” as the next step towards fulfilling a primary objective in the newly inked letter of intent, according to a press release.
The company said it is anticipating a 2017 launch of the sugarBEAT CGM in Europe after receiving CE Mark approval in the European union in March.
In August, Nemaura met with the FDA to discuss the clinical programs necessary for pursuing premarket approval submission for its sugarBEAT.
The U.K.-based company said that as a result of the meeting it “determined a clear direction for the clinical program” and has picked Navigant to develop an investigational device exemption application for the device prior to launching a clinical program.
Nemaura hopes to submit its PMA application around mid 2017, according to a press release.
The post Nemaura Medical inks JV deal with Chinese Academy of Science affiliate appeared first on MassDevice.
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