The European Union has granted CE mark certification to ApiFix's minimally invasive treatment system for use in patients with Adolescent Idiopathic Scoliosis (AIS).
Designed as an alternative to complex spinal surgeries, the ApiFix AIS correction system uses only two screws to attach a small implant to the center of the main spinal curvature and makes a 10 cm scar, when compared to over 40 cm scar in the standard procedure.
After recovering from surgery, which takes about an hour, the patient will undergo physical therapy treatments, during which the implant is gradually ‘educating’ the spine into a correct position and ‘remembers’ and reinforces each correction made, according to the company.
The approval is based on positive results from a pilot European clinical trial, which implanted the system in patients with AIS.
ApiFix CEO Uri Arnin said the results demonstrate the implant’s safety and success in correcting the curvature.
"Within about three months, we achieved an impressive result, while maintaining spinal flexibility," Arnin added.
ApiFix is expecting to start marketing the device to the European hospitals during 2013.
The company said its major investors are the Trendlines Group and private US investors.