MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, the technology leader in cushion-bearing orthopedics for treatment of osteoarthritis, today announced it has received Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant in patients with knee osteoarthritis.
The “VENUS”-study (Verification of the Effectiveness of the NUsurface® System) is a prospective, randomized, multicenter study to demonstrate superiority of the NUsurface® Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery.
“Clinical studies outside the USA have shown that the NUsurface® Meniscus Implant results in significant pain relief and restoration of function compared to currently available treatments,” said Henry Klyce, Chairman and CEO of Active Implants. “Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S.”
Elliott Hershman, M.D. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Dr. Hershman said, “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 caused by a previous meniscectomy, meniscus dysfunction or insufficiency. The NUsurface® Meniscus Implant was designed to meet the needs of patients too old for meniscus repair and too young for a knee replacement.”
For the past three years, Active Implants has been working with leading knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a prospective controlled, Multi-Center Trial of the NUsurface® Meniscus Implant. Peter Verdonk, M.D., PhD, an investigator in the Multi-Center trial from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, 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.”
About the NUsurface® Meniscus Implant: The NUsurface® Meniscus Implant is an artificial device designed to help relieve knee pain and restore function similar to that of the healthy meniscus. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The device is approved in Europe under CE regulations and in Israel. The Company believes the NUsurface® device could be used to treat several hundreds of thousands of patients a year whose earlier meniscectomy treatments have not been successful but are not yet candidates for knee arthroplasty. The potential worldwide market for the NUsurface® is estimated at more than $2 Billion annually.
The mission of Active Implants LLC is to develop orthopaedic implant solutions that integrate with the natural biomechanics of the musculoskeletal system and allow patients to maintain or return to an active lifestyle. The Company’s main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface® Meniscus Implant for patients with knee pain. Active Implants LLC, a privately held, multi-national company, is headquartered in Memphis, Tennessee USA, with additional offices in Driebergen, The Netherlands, and Netanya, Israel.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding Active Implants’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from Active Implants’ expectations. Factors that may affect the actual results achieved by Active Implants include, without limitation, the ability of Active Implants to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of Active Implants to integrate purchased businesses, R&D capabilities, infrastructure and employees. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
The NUsurface® Implant has been CE-approved for commercialization in the European Union and Israel.