Medigus Announces the Receipt of Approval from the Israeli Ministry of Health (MEA) for the Marketing of SRS™ Systems for the Treatment of Gastroesophageal Reflux Disease (GERD)
Medigus announced today that it had received approval from the Israeli Ministry of Health for the registration of the SRS™ system for the treatment of gastroesophageal reflux disease (GERD) in the Israeli Register of Medical Equipment and Accessories (MEA Approval). In addition to the foregoing approval, the SRS™ system has been granted FDA marketing clearance for the marketing and sale of the system in the United States, CE approval for the marketing and approval of the system in Europe, and approval for marketing in Canada from Health Canada.
The MEA approval for the system is a precondition for the purchase of medical equipment by medical institutions and HMOs in Israel. Its receipt is also 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.
The minimally invasive treatment with the SRS™ system developed by Medigus has been found to be as effective and safe as the invasive surgical treatment which is currently the “gold standard” for patients with severe cases of GERD. This is made possible, inter alia, by similar tissue positioning after the procedure, and by performing an operation which is simpler and free of pain, and which requires a shorter recovery period. Medigus is currently in the preliminary stages of marketing the SRS™ system in the United States and in Europe, both independently and through distributors.
Dr. Elazar Sonnenschein, CEO of Medigus:: “We are pleased and excited to announce the receipt of MEA approval for the marketing of the SRS™ system in Israel. The receipt of this approval is a natural development of our strategy. The Israeli market is an important and advanced market which is continuously pursuing technological innovations in the various fields of medicine, and is looking to adopt advanced treatments which meet high standards of efficacy and safety. The receipt of MEA approval is expected to assist us in advancing the process of receiving SFDA approval for marketing the system in China. The SRS™ system and the technology upon which it is based have been received positively by experts in the fields of gastroenterology and minimally invasive medicine in Israel. Now that MEA approval has been obtained, we look forward to commencing our activity with them, and to performing procedures using the system.”