* Implant addresses market of over $1 billion
* Company expects to be profitable by end of 2014
By Tova Cohen
TEL AVIV, Feb 27 A medical implant developed by
Premia Spine offers patients with certain spinal disorders an
alternative to traditional fusion surgeries, enabling a quicker
recovery and greatly reducing the risk of reoperation, the
Israeli company said.
The device called TOPS is fixed to the spine with screws and
differs from other products on the market in that it has a
central polyurethane unit that moves, recreating motion in all
directions. It addresses two lower back ailments:
spondylolisthesis, commonly known as a slipped disc, and lumbar
spinal stenosis (LSS), a form of spinal arthritis associated
"With the TOPS System, instead of immobilising we replace
the diseased segment with an artificial joint," Premia Spine
Chief Executive Ron Sacher said, likening the procedure to hip
and knee replacements patients now undergo instead of the fusion
surgeries that were once common.
Fusion surgery in the lower back eliminates one of the three
key motion segments, making the other two segments work much
harder. Within a few years patients often require more surgery.
According to a study of lumbar spinal fusions in the United
States whose results were presented at a symposium in Barcelona
last year, one in four elderly fusion patients being treated for
LSS or spondylolisthesis had to have a second operation on the
spine within two years of surgery.
Nearly one in two elderly patients who underwent fusion
surgery had to be readmitted to hospital after complications.
After completing five-year follow-ups on patients from
trials in Belgium and Israel, Premia Spine believes its results
are significantly better than those achieved by fusion. The TOPS
System overall reoperative rate is less than five percent,
Sacher told Reuters.
The drawback to Premia Spine's device is that it is more
expensive, and while the extra cost is covered by public health
systems, private insurers do not always do so.
According to Sacher, 650,000 people a year undergo lumbar
spinal fusion for a variety of ailments and Premia Spine
addresses about 35 percent of that $3 billion-a-year market.
Competing implants for spinal fusion are made by Medtronic
, Johnson & Johnson, Stryker Corp, Zimmer
Holdings and NuVasive Inc.
Premia Spine began selling its product late last year, when
sales totalled hundreds of thousands of shekels.
"This year we are looking at millions of shekels in sales,"
said Sacher, who sold his first start-up SI Therapies to Boston
Scientific for $29.5 million. The company expects to be
profitable by the end of 2014.
TOPS System is available in Germany, Austria, Britain and
Turkey, as well as Israel. It will soon be launched in Belgium
By April the company expects approval to sell the product in
at least one Asian country. It has submitted applications in
Hong Kong, Singapore, India and Thailand and Sacher foresees
approval in those markets by the end of the year.
Premia Spine is conducting clinical trials in the United
States but Sacher said it could take five years to get U.S. Food
and Drug Administration approval.