OMER, ISRAEL--(Marketwired - Feb 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.
About Medigus
Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly
innovative imaging solutions. They are the pioneer developer of the MUSE™ system, an FDA cleared and CE marked endoscopic device
to perform Transoral Fundoplication (TF) for the treatment of GERD (gastroesophageal reflux disease), one of the most common
chronic conditions in the world. In 2016, the CMS established the Category I CPT® Code of 43210 for TF procedures, such as the
ones performed with MUSE, which establishes reimbursement values for physicians and hospitals. MUSE is gaining adoption in key
markets around the world -- it is available in world-leading healthcare institutions in the U.S., Europe and Israel. Medigus is
also in the process of obtaining regulatory clearance in China. Medigus is traded on the Nasdaq Capital Market and the TASE
(Tel-Aviv Stock Exchange). To learn more about the company's advanced technology, please visit www.medigus.com or www.RefluxHelp.com.
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