Medigus Receives Approval for Commencement of the First Multi-Center MUSE™ Clinical Study from CFDA in China
OMER, Israel, February 16, 2017 — 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 the China Food and Drug Administration, or CFDA, has approved the commencement of the first multi-center MUSE™ Clinical Study in China.
Approval to start the multi-center MUSE™ clinical study was received after the CFDA reviewed the ethics committees' approval and agreements were in place with each center. Under Principal Investigator, 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, the clinical study of approximately 62 patients, will take place at 5 centers across China:
• The General Hospital of People’s Liberation Army
• Renji Hospital of Shanghai
• Shanghai General Hospital
• Peking University Third Hospital
• Navy General Hospital
Procedures are expected to start in March and carry on through 2017, with results being reported to the CFDA in 2018 as part of the submission for clearance to sell MUSE™ in China.
“With the approval of the clinical study, we are now a step closer to the first-in-man MUSE™ procedure in China,” said Chris Rowland, CEO of Medigus. “We will continue to work closely with our partners to expand the use of MUSE worldwide.”
As Medigus works to obtain CFDA approval for MUSE™, the company is in progressive negotiations pertaining to an addendum to its current agreement with Shanghai Golden-Grand Medical Instruments Co. Ltd., or Golden, under which Medigus intends to provide Golden an aggregate sum of US$175,000 to be used in financing of the efforts. Golden is a Chinese company specializing in the distribution of medical devices in the gastroenterology field, which was appointed as a sub-distributor by Sinopharm (China National Pharmaceutical Group Corporation) – Medigus’ exclusive distributor of MUSETM in China. In regards to the agreement addendum, the amount is expected to be transferred to Golden in two tranches. The anticipated timeline is as follows, the first tranche, in the amount of US$ 100,000, transferred to Golden within ten workdays from signing the addendum and the remaining US$ 75,000 be transferred to Golden within ten workdays from the date of completion of the first human procedure using the MUSE™.
The MUSE system is a single-use flexible transoral stapler that merges the latest advancements in microvisual, ultrasonic and surgical stapling. The device comes equipped with an ultrasonic sight and range finder and a micro ScoutCam™ CMOS camera, which enables a single physician to perform an incisionless transoral fundoplication — the procedure intended to treat the anatomical cause of gastroesophageal reflux disease (GERD).
For more information about the clinical study or to determine if you are eligible for the trial, patients can directly contact participating medical centers.