|By Marketwired .||
|February 16, 2017 07:00 AM EST|
OMER, ISRAEL -- (Marketwired) -- 02/16/17 -- 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.
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.
This press release may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions and expectations of the company's management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These forward-looking statements represent Medigus' expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Other risk factors affecting the company are discussed in detail in the Company's filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.
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