100 Patients Enrolled in Multi-Center Study
MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants Corporation today announces the enrollment of the one hundredth patient in an outside-the-U.S., post-market, prospective, Multi-Center Trial of the NUsurface® Meniscus Implant. The NUsurface® Meniscus Implant is a novel, composite polymer implant which is used to treat knee patients who have pain and disability arising from osteoarthritis (OA) caused by a previous meniscectomy and/or meniscus dysfunction or insufficiency.
Active Implants Corporation is working with leading knee sports medicine surgeons in Belgium, Italy, Israel, and Germany on a prospective controlled, Multi-Center Trial of the NUsurface® Meniscus Implant. The company believes that the NUsurface® Meniscus Implant will meet the needs of patients too old for meniscus repair and too young for a total knee replacement.
Peter Verdonk, M.D., PhD, from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, who has been enrolling patients in the study for two years said, “I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement.”
Elliott Hershman, M.D., the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York has been involved with the NUsurface® project since its inception, and is the Chief Medical Advisor of Active Implants Corporation. Since May 2011, Dr. Hershman has been conducting a concurrent, non-randomized control study of patients with the identical inclusion/exclusion criteria. Dr. Hershman said, “A comparison of the results from these two groups will allow the effect of the NUsurface® Meniscus Implant on patient pain and function to be evaluated.”
Active Implants Corporation estimates the annual worldwide market for the NUsurface® product to be over $2 billion.
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant is designed to relieve knee pain and restore function by redistributing the load similar to the function of the natural healthy meniscus. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The product is approved in Europe under CE regulations and in Israel. The company believes the NUsurface® device could treat several hundreds of thousands of patients per year whose earlier (partial) meniscectomy treatments have not been successful and yet are not ready or old enough for late stage knee arthroplasty.
Active Implants Corporation is a privately held Delaware corporation formed in June 2004, based in Memphis TN USA. The company’s core technology is intended to introduce orthopedic implant solutions that better integrate with the natural biomechanics of the musculoskeletal system. The company has additional offices in Driebergen, The Netherlands and Netanya, Israel.