By Avigayil Kadesh
People with an extremely curved spine can get the problem fixed, but it involves six hours of surgery, during which several vertebrae are fused together using an average of 20 bone screws.
The best available procedure to ease severe scoliosis today, it costs upward of $100,000 and entails a long recovery time. Worst of all, it does not always yield perfect results.
The Israeli company ApiFix
is poised to change all that with a small, expandable titanium ratchet inserted through a small incision and secured to the backbone with just two screws. This much quicker method minimizes risks, scar size, complications, recovery time and cost. Just as importantly, results can be adjusted over time without the need for further surgery. Using a patented control mechanism, the physician can lock or unlock the rod via a needle procedure to allow for incremental corrections.
“One of the limits of the technology to correct scoliosis today is the need to make a correction in one surgery,” says ApiFix founder Uri Arnin.
He explains that the usual procedure addresses the bony part of the spine but ignores the surrounding soft tissue. These ligaments and muscles pull against the bone, often undoing the work of the surgeon.
“Soft tissues take time to become flexible,” says Arnin. “If you do it over a period of days or weeks, they relax enough to realign themselves in the correct position.”
An engineer-surgeon team
The half-million-dollar budget from the incubator has allowed for the development of the device conceived by Arnin, an engineer specializing in spinal medical devices, and Dr. Yizhar Floman, a leading Israeli back surgeon. They had collaborated on other projects over the past decade.
ApiFix is starting clinical trials in Hungary and Romania, where the approval process is comparatively fast. “In Israel it would take about a year, and in Hungary and Romania the surgeons are very experienced,” says Arnin.
The trials involve adolescent patients, because “younger ligaments are easier to manipulate and the quality of the bone is much better,” Arnin explains.
Each procedure costs $20,000 to $25,000. There’s enough funding right now for four patients.
“Based on the initial outcome, we hope to raise additional money and do trials on 30 patients with two years of follow-up,” says Arnin. “If we can get $100,000 or $200,000, we could complete CE certification within half a year and start selling ApiFix in private centers.”
The approval process in the United States can take years, but interest is likely to be high because about 40,000 Americans undergo surgery for scoliosis correction every year. The potential market for ApiFix is $600 million in the US and $300 million elsewhere.
The area of spinal technology is years behind other medical advances, Arnin adds. “There is almost no sophisticated technology available, and I think ApiFix will contribute a lot to the standard of care in this field.”
Once they are approved for sale, the devices will be manufactured in Israel. “The level of technicians and machinery and knowledge we have here is top notch on a world level. We have no reason to outsource it abroad because we have great capabilities right here,” he explains.