Medigus (NASDAQ: MDGS) this morning said that the first 10 procedures have been performed as the initial phase of the China Food and Drug Administration (CFDA) multi-center MUSE™ clinical study. The procedures for the clinical study, which will include roughly 62 patients, have started at four hospitals in China and are expected to continue through 2017. Data from the trial is anticipated to be reported to the CFDA in 2018 as part of the company’s submission for approval to sell MUSE™ in China. “We are looking forward to a successful clinical trial in China, which will lead to higher adoption of MUSE in the East Asian market, which has an increasing prevalence of GERD,” CEO Chris Rowland stated in the news release.
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Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly innovative imaging solutions. The company is 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. To learn more about the company’s technology, please visit www.medigus.com.
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