Medigus to Begin Clinical Study in China for CFDA Regulatory ClearanceOMER, Israel, February 8, 2016 — Medigus Ltd. (NASDAQ: MDGS) (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced that Golden Grand (Shanghai Golden Grand-Medical Instruments Ltd.), sub-contracted through Sinopharm (China National Pharmaceutical Group Corporation), will use the Medigus Ultrasonic Surgical Endostapler (MUSE™) in a transoral fundoplication clinical study in China. Medigus has received the first purchase order for the initial devices to be used in the study, and plans to deliver the equipment within one month.
As part of its regulatory clearance process, the China Food and Drug Administration (CFDA) requires certain types of medical devices undergo additional clinical trials in their country prior to granting certification. The study will be conducted in seven of China’s leading medical centers— four in Beijing and three in Shanghai— and will be led by Principal Investigator, Professor Yunsheng Yang, Director of Gastroenterology Department Clinical center at 301 Hospital and chairman of Chinese Society Of Gastroenterology, The General Hospital of People's Liberation Army in Beijing. Study results will be used for the CFDA regulatory clearance process.
“The global adoption of endoscopic fundoplication procedures using MUSE is continuing to expand,” said Chris Rowland, CEO of Medigus. “We are looking forward to the commencement of this trial, as it is an important step in gaining regulatory clearance in China.”
MUSE merges the latest advancements in microvisual, ultrasonic and surgical technologies into a comprehensive platform that allows a single physician or surgeon to perform fundoplication (stapling of the upper part of the stomach to the lower esophageal sphincter), a procedure intended to deliver long-term relief from gastroesophageal reflux disease (GERD).