Following Positive Clinical Results, ApiFix Receives CE Mark for its Innovative Treatment System for Scoliosis
MISGAV, Israel, February 14, 2013 /PRNewswire/ --
ApiFix Ltd., recently received CE Mark for its minimally invasive treatment system for Adolescent Idiopathic Scoliosis (AIS). ApiFix also reports that it has successfully completed a pilot clinical trial with positive results.
Today's gold standard for correction AIS involves permanent spinal fusion of an average of 10 motion levels, using a large number of screws, in a surgical procedure that lasts around six hours and costs upward of $100,000. The revolutionary ApiFix AIS correction system minimizes risk, pain and scarring for the patient; and speeds recovery time. The shorter, simpler procedure costs less, as well. In the ApiFix system, a small implant is attached to the center of the main spinal curvature using only two screws, resulting a 10 cm scar, compared to over 40 cm scar in the standard procedure. After recovering from surgery, which takes only about an hour, the patient undergoes physical therapy treatments, during which the implant is gradually "educating" the spine into a correct position and "remembers" and reinforces each correction made.
Recently, ApiFix successfully completed a pilot clinical trial in Europe, during which implants were executed in patients suffering from AIS. "The results demonstrate the implant's safety and success in correcting the curvature," noted Uri Arnin, ApiFix CEO and an entrepreneur with vast experience in the spinal implants field. "Within about three months, we achieved an impressive result, while maintaining spinal flexibility." The company also reports that the product has been CE mark approved, which will allow ApiFix to begin marketing its device throughout Europe.
From the outset, the company has worked in partnership with Prof. Yizhar Floman, a spine surgeon at Assuta Hospital, Israel. The major investors in the company are The Trendlines Group and private U.S. investors. During 2013, ApiFix will begin marketing the product to hospitals in Europe. The AIS surgery market is currently estimated at approximately $700 million, with some 70,000 procedures annually.
Dr. Eran Feldhay, Corporate VP, Life Sciences, The Trendlines Group: "ApiFix has developed an effective, yet simple treatment that provides a revolutionary alternative to complex spinal surgeries that are currently standard practice. The company has sparked a great deal of interest and provides a solution for tens of thousands of young people around the world who suffer from AIS."
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SOURCE ApiFix Ltd.