By Tova Cohen
TEL AVIV (Reuters) - 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 ageing.
"With the TOPS System, instead of immobilizing 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 totaled 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 and Switzerland.
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.
(Editing by Jeffrey Heller)