Healthcare Industry News: ultrasound
News Release - September 12, 2013
Medigus Announces Marketing Approval from the Israeli Ministry of Health (MEA) for SRS(TM) System for the Treatment of Gastroesophageal Reflux Disease (GERD)Approval is Expected to Expedite Regulatory Approvals in Other Countries, Including Regulatory Authorities in China (SFDA)
OMER, Israel, Sept. 12, 2013 -- (Healthcare Sales & Marketing Network) -- Medigus (MDGS.TA), a medical equipment company focused on the development and marketing of endoscopy-based medical procedures, announced today that it had received approval from the Israeli Ministry of Health for the registration of the SRS(TM) system for the treatment of Gastroesophageal Reflux Disease (GERD) in the Israeli Register of Medical Equipment and Accessories (MEA Approval). This approval follows FDA marketing clearance for the marketing and sales of the system in the United States, CE mark in Europe and approval for marketing in Canada from Health Canada, all of which had been attained earlier.
Its receipt is expected to facilitate the process of receiving regulatory approvals in other countries, including approval from the regulatory authorities in China (SFDA), where the company has signed a distribution agreement with a minimum value of USD $4 million with Sinopharm, the Chinese governmental medical device distribution company.
SRS(TM) system, the minimally invasive treatment, has been found to be as effective and safe as invasive surgical treatment currently considered the "gold standard" for patients with severe GERD. This is made possible, inter alia, by similar tissue positioning after the procedure, and by performing an operation which is less complex and pain free, and which requires a shorter recovery period. Medigus is currently in the preliminary stages of marketing the SRS(TM) system in the United States and Europe, both independently and through distributors.
"The receipt of this approval in Israel is a natural development of our strategy and particularly important to our company and its shareholders. The Israeli market is an important and advanced market that is continuously pursuing technological innovations in the various fields of medicine, and is looking to adopt advanced treatments that meet high standards of efficacy and safety," said Dr. Elazar Sonenschein, CEO of Medigus. "We expect the MEA approval to assist us in advancing the process of receiving SFDA approval for marketing the system in China."
Medigus (MDGS.TA) is a publicly traded, medical equipment company focused on the development and marketing of surgical endoscopes. The company developed the SRS(TM) endoscopic system, intended as a minimally invasive treatment for Gastroesophageal Reflux Disease (GERD), one of the most widespread chronic diseases in the Western world, affecting 5%-7% of the world's population. Millions of people take expensive drugs to treat the symptoms of the disease, and hundreds of thousands of invasive surgeries are performed each year.
In May 2013, Medigus published the results of a 5 year follow-up trial, after performing a pilot trial in India in 2007, followed by an extended multi-center clinical trial in medical centers in various countries, including the United States, Germany and Austria, which demonstrated that the results obtained from the minimally invasive endoscopic procedure performed using the SRS(TM) system (guided by the miniature cameras and ultrasound technology which are embedded in the endoscope) are similar to the surgical results obtained by the "gold standard" surgical procedure during the same follow-up period. These results demonstrate the long term efficacy of the SRS(TM) system, and its ability to serve as an alternative to invasive surgery for patients suffering from severe cases of GERD.
The SRS(TM) system has FDA approval for marketing and sale in the United States, CE approval for marketing and sale in European Union countries, and approval for marketing in Canada from Health Canada.
Medigus is currently in the preliminary stages of marketing the SRS(TM) system in the United States and in Europe, both independently and through distributors.
In addition to the aforementioned primary area of operation, Medigus also develops and markets miniature endoscopic video cameras of various sizes, which are applicable to a variety of industrial and scientific uses.
In March 2013, Orbimed Israel Partners completed an investment of USD 8 million in Medigus, against the allocation of approx. 30.7% of the shares and voting rights in the company, and became the controlling shareholder in Medigus.
Additional information is available on the company's website at www.medigus.com
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