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News
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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."
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