FRANKLIN, MA – (PR Newswire) – July 27, 2004 – Arthrosurface, Inc. (arthro3b.wpengine.com), the developer of a new less invasive joint resurfacing system, announced that it has received CE Mark approval for distribution of the HemiCAP™ implant device in Europe. The company’s HemiCAP™ system consists of a range of contoured articular prosthetics and instrumentation intended for the repair of significant lesions and cartilage damage in the major joints. CE Mark approval allows European commercialization for treatment of knees, hips and shoulders. Currently, Arthrosurface also has United States’ 510k approvals for commercial application in hips, shoulders and great toe with the knee approval pending an FDA clinical trial. Knee clinical trials will continue to be conducted throughout the year and into 2005.
The HemiCAP™ device has now been implanted in the knee, hip and shoulder. Nearly 100 implantations have been performed in the US and Europe with several patients now beyond the one-year mark.
“We are pleased with the responses we have received from surgeons and continue to believe that this minimal intervention approach to joint resurfacing is a viable alternative for the appropriate patients”, said Steve Ek, COO. “Surgeons have been seeking a simpler and less invasive treatment for localized osteochondral lesions and the Arthrosurface technology was developed specifically for this need.”
“Arthrosurface has begun to capitalize on its technology with the establishment of its national distributor network in the United States. In just a couple of months we have also established a strong European distributor network in the major EU markets and our expansion into other strategic markets will continue throughout the remainder of this year”, said Arthrosurface’s President, Steve Tallarida.
Arthrosurface, headquartered in Franklin, MA, develops minimally invasive joint resurfacing systems. The company’s HemiCAP™ system is a platform technology providing a surgical alternative to conventional treatment methods.
Anthony C. Moretti, CFO
28 Forge Parkway
Franklin, MA 02038