Medigus has obtained approval from the Israeli Ministry of Health (MEA) for the SRS endoscopic system, designed for the treatment of gastroesophageal reflux disease (GERD).
The SRS system is used in the minimally invasive procedure guided by the miniature cameras and ultrasound technology embedded in the endoscope.
The incision-free treatment with the SRS system is 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.
GERD is regarded as one of the most widespread chronic diseases in the Western world, affecting 5%-7% of the population.
Medigus CEO Dr Elazar Sonenschein said that receipt of this approval in Israel is a natural development of company’s strategy and particularly important to the company and its shareholders.
"We expect the MEA approval to assist us in advancing the process of receiving SFDA approval for marketing the system in China," Dr Sonenschein said.
The SRS system has previously been granted the US Food and Drug Administration (FDA) marketing clearance for the marketing and sale of the system in the US, CE approval in Europe, as well as from Health Canada in the country.
The MEA approval is likely to expedite regulatory approvals in other countries, including SFDA approval for marketing the system in China.
Medigus has previously signed a $4m distribution agreement with the Chinese governmental medical device distribution company Sinopharm.
The company is currently in the initial stages of marketing the SRS system in the US and Europe, both independently and through distributors.
According to GlobalData estimates, endoscopy devices market in Israel was valued at $23m in 2012 and is expected to grow at a CAGR of 4.5% to reach $31m by 2019.