Medigus’s SRS procedure is performed through the mouth using endoscopic technology. It doesn’t require anesthesia or a long hospital stay, it can be done in a half hour.You may fight heartburn by occasionally popping a ‘Tums’, or just might ignore it, but what is often viewed as mere discomfort can develop into a very serious medical condition.
An estimated 44% of the 61 million adults living in the United States have heartburn – the hallmark of acid regurgitation – at least once a month. In most cases, no serious or permanent damage results; but in some people, chronic heartburn, known as gastroesophageal reflux disease (GERD), may cause serious complications such as esophagitis, peptic strictures, ulcers, laryngeal disease, chronic cough, asthma, Barrett’s esophagus, and adenocarcinoma.
One of the most common chronic diseases in the western world, GERD is usually caused by an abnormality of function or a mechanical problem in the relaxation of the lower esophageal sphincter (LES), which allows the stomach contents to reflux into the esophagus. Severe GERD is a common, chronic, reoccuring condition in which a patient continues to have acid breakthrough even while taking acid suppression therapy or after cessation of therapy.
Over 150,000 Americans who suffer from severe GERD annually undergo an invasive surgical procedure which staples the stomach lining around the esophagus, – a process called fundoplication – thereby prevented acid reflux.
Now, Israeli startup Medigus has developed an endoscopic device to replace the need for surgery for stapling the stomach, which is completely non-invasive while performing the same function as surgery. Its SRS system combines a specialized flexible endoscope, miniaturized video camera, ultrasonic sights for alignment and a surgical stapler. The device already has CE Mark safety certification and can be sold in Europe; however the company is waiting for FDA approval in the US before it begins to market the device.
The company recently announced the completion of initial human trials on four patients at the Flinders Medical Center, Adelaide Australia. The results of the trials will determine whether the company will continue with additional trials in Europe and the US in order to apply for FDA approval for the treatment and for marketing of the device.
“Until today, the standard procedures to treat severe GERD has been invasive open surgery or a laparoscopic procedure,” explained Adi Frish, chief of business development for the company, which is based in Omer, a suburb of Beersheva. “Basically, by closing off the esophageal opening into the stomach, gastroenterologists alleviate the pressure in the stomach, thus preventing the reflux from occurring.”
“Our device achieves the same result but the procedure is performed through the mouth using endoscopic technology. It doesn’t require anesthesia or a long hospital stay, it can be done in 15 minutes or a half hour, and it’s non-invasive,” he told ISRAEL21c.
He added that the success rate of the SRS in treating GERD is expected to match that of existing ‘gold-standard’ surgical procedures, but with a far simpler, and less expensive procedure.
Founded in 2000, Medigus is the brainchild of its founder and CEO Elazar Sonnenschein, a PhD in computer engineering with vast experience in the field of ultrasound imaging who had already achieved success in the business world and was looking for a new challenge.
“Six years ago I was looking for a new procedure which could be performed using endoscopy,” he told ISRAEL21c.
“I reviewed several medical problems, and met with Dr. Avi Shapira, (a tenured surgeon at Soroka Hospital and now Medigus medical manager). He described GERD and the current form of surgical treatment, and I became intrigued at the challenge was to convert the surgery into an endoscopic procedure.”
Together with partner Yair Rabinowitch, a former Israeli income tax commissioner, Sonnenschein founded the company, using only his own money at first, before taking on investors.
“There were some open questions that I thought I should solve first before looking for investment. That took about eight months, and when I felt I had satisfactory answers, I went to raise money from investors,” he said.
Among the takers were ProSeed Venture Capital Fund, Israel Healthcare Ventures Ltd., Ofer Hi Tech Ltd., Delta Ventures, Biocom Fund, and Dexxon. Private investors include Rabinowich, Osem controlling shareholder Gad Propper, and television emcee Nissim Mishal. During second stage funding, Johnson and Johnson subsidiary Ethicon Endo-Surgery joined the backers.
Today, with 35 employees and publicly traded on the Tel Aviv Stock Exchange (TASE:MDGS), Medigus is building on the success of its endoscopic system for GERD. Development of its endoscopic system for GERD involved development of a miniature camera, which, according to Frisch and Sonnenschein, will be the cornerstone for future applications in other areas.
“As part of designing the GERD procedure, we’ve developed a 1.8mm video camera – which I believe is the smallest high-performance CCD camera in the world,” said Frisch.
The camera is used for visualizing hard-to-access areas of the human body. The company also developed special patented techniques for miniaturization and assembly of the camera head and lenses. All cameras and optics are assembled at the company’s premises in Omer, emphasized Frisch.
Having the technology already in place will make new applications much easier to develop, he added. “We intend to use the technology to develop other devices.”
Sonnenschein was a little more specific, stating that “We’ve recently started working on a new procedure in urology.”
He expressed satisfaction at where the company and its technology has arrived at in the last six years.
“I’m very pleased with the pace of development of the SRS. Our final goal is to receive FDA approval, and we’re right on track for that.”