Medigus (TLV:MDGS) said today it won approval from the China Food and Drug Administration to initiate a clinical study of its Muse endoscopic device designed for trans oral fundoplication procedures to treat gastroesophageal reflux disease.
The Chinese Muse trial is slated to enroll 62 patients at across 5 centers in China, including The General Hospital of People’s Liberation Army, Renji Hospital in Shanghai, Shanghai Geenral Hospital, Peking University Third Hospital and Navy General Hospital.
“With the approval of the clinical study, we are now a step closer to the first-in-man Muse procedure in China. We will continue to work closely with our partners to expand the use of Muse worldwide,” CEO Chris Rowland said in a press release.
The company said procedures are expected to begin at those centers in March and continue through 2017, with results ready in 2018 as part of the company’s submission as it seeks clearance for the device in China.
In July 2015, Medigus said it raised $3m in a closed equity financing round, according to an SEC filing from the endosurgical and imaging device company. The company also partnered with NASA, providing micro ScoutCams for its Robotic Refueling Mission.
A month earlier, Medigus won a contract to supply NASA with its micro ScoutCam miniature video cameras and advanced processing equipment for use with its Robotic Refueling Mission.