ApiFix® Ltd. points to the fact that one to three year follow-up of 25 patients supports the use of its ApiFix® system, which has now been used to correct scoliosis in 50 adolescents since the system was approved for marketing in Europe.
Scoliosis surgery is the most invasive procedure in spine, yielding an unmet need for something rather less invasive. To this end, Israeli company ApiFix® Ltd. has developed and CE-marked the ApiFix® System, a non-fusion minimally invasive treatment alternative for Adolescent Idiopathic Scoliosis (AIS). The average procedure fuses 10 vertebrae together using 20 screws, resulting in significant and permanent loss of spine mobility.
A clinical study of The ApiFix® System led by Prof. Yizhar Floman, M.D. past President of the Israel Spine Society, published this year in the peer-reviewed medical journal Scoliosis concluded that “there are many drawbacks to the current gold standard of AIS surgery, which are almost nonexistent with the use of ApiFix: considerable blood loss leading to blood transfusions, neurologic deficit including spinal cord lesions, late infections, pseudoarthrosis, limitation of spinal motion also affecting non-fused levels, back pain and disc degeneration in the non-fused spinal segments. Almost all of these complications can be avoided by the use of Apifix.”
“Scoliosis curve correction at one-to-three years follow-up is substantial for these adolescents. Equally important, patients are pain-free and happy with their new back shape. No implant failure has been observed,” said Prof. Yizhar Floman, M.D., principal investigator for the ApiFix® clinical study.
“There is a dire need for an alternative to today’s standard for scoliosis correction in adolescents 12 to 18 years old, the age when rapid growth typically occurs,” said Uri Arnin, CEO, headquartered in Misgav, Israel. “In 80 percent of these children, the cause of their scoliosis is ‘idiopathic’, or unknown. While the reduction in spine mobility is certainly a difficult consequence of long spinal fusions, which are the gold standard of treating scoliosis today, other critically important negative consequences include high chance for back pain and additional spine surgery during the first 20 years post-original surgery.”
“Now, there’s the ApiFix system,” added Ted Bird, Chairman, based in Charleston, S.C., USA. “It is approved for sale in Europe. We are currently raising funding in order to fast-forward our sales-and-marketing efforts to launch a device that is designed to be a new standard for correcting scoliosis in adolescents.”
Source: ApiFix Ltd.