Israeli sponsor Medigus Ltd. (NASDAQ) has completed patient enrollment in China for its MUSE clinical study. Medigus is seeking China Food and Drug Administration (CFDA) approval of its MUSE System 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 57 patients, took 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
- Rocket Force Hospital
The interim results of the first group of patients in the study that were presented in academic conferences in China were better than expected. The vast majority of these patients showed a significant relief of GERD symptoms as well as a significant improvement in objective measurements of acid reflux. The results of each patient are collected during a period of six months post-procedure. Once the results of the last patients will be collected, all data will be analysed statistically by an external Clinical Research Organization (CRO) and the official final report will be submitted to the CFDA as part of the submission for clearance to sell MUSE™ in China.
“With the completion of the patient recruitment of the clinical study, we have made a significant step closer to commercial use of the MUSE™ procedure in China,” said Prof. Benad Goldwasser, Medigus Chairman of the Board.
What is the MUSE System?
The MUSE™ system solution for GERD is functionally identical to a standard laparoscopic procedure (anterior fundoplication). It restores a normal gastro-esophageal flap valve. Consequently, the available clinical results to date compare favorably with the results of laparoscopic surgery.
Yunsheng Yang, Director of Gastroenterology Department