Enrollment Reaches 35 Patients in Multi-Centered NUsurface® Artificial Meniscal Study in EU and Israel
Henry Klyce takes over as President & CEO
EMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants Corporation (AIC), a pioneer in pliable orthopaedic implant technology, announced that current investors have committed $10 MM in additional capital to continue the NUsurface device study. The Company also announced a change in management and provided an update on the status of its NUsurface clinical study.
Multi-Center, Prospective Study Enrollment On-Track
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. It is implanted by orthopaedic surgeons using a mini-open procedure in conjunction with routine arthroscopy. The Company believes the NUsurface® device could address several hundreds of thousands of patients per year whose earlier treatments have not been successful and are not yet ready for later stage knee arthroplasty.
The goal of the prospective, controlled study is to create clinical data related to the safety, performance, and risk/benefit of the device in the intended patient population. The Company expects to enroll 100 patients and obtain 2 year follow up data, and reports that 35 patients have already been enrolled.
Elliott Hershman, MD, Chairman, Orthopedics, Lenox Hill Hospital, NY and Study Medical Director stated, “With the additional evidence generated in this Multi-Centered study, we intend to develop sufficient data to support the use of the NUsurface device in patients who require a more effective solution than available with current treatment options.”
“With the funding, the company will focus on completing enrollment and follow up of the clinical study of the NUsurface® Meniscus Implant. In conjunction with this strategy, it’s the right time for me to step down,” said outgoing President & CEO, Michael Mainelli.
“On behalf of the Board of Directors, we thank Mike Mainelli for the outstanding job he’s done for the Company as CEO,” stated Henry Klyce, Director.
Jimmy Lackie, Director and representative of the lead investor group added, “Mike is a professional of great character whose leadership skills and extensive business experience will be an asset to any organization he decides to join. We are pleased he will be able to continue to serve as a Director of Active Implants.”
Mr. Mainelli further stated, “I’m very proud to have worked with this global team of world-class clinicians and employees over the last few years. I want to emphasize that in no way is my departure due to a lack of enthusiasm for the market potential of this exciting new technology. The leadership needs of the business have simply changed.”
Henry Klyce, a member of the Board of Directors since 2008, assumes the role of CEO. A graduate of Cornell University, Henry is a very successful and highly regarded medical device entrepreneur. Over the past 20 years, he has founded and developed many companies, including Surgical Dynamics (sold to US Surgical) and St. Francis Medical Technologies (sold to Kyphon/Medtronic) that have generated almost one billion dollars in shareholder value. Jimmy Lackie further stated, “The Board is fortunate to have someone of Henry’s outstanding reputation, skill, knowledge, and successful operating experience assume a leadership role in the development of the Company’s platform technology.”
About Active Implants Corporation: Active Implants Corporation is a privately-held company formed in 2004. The company is headquartered in Memphis, Tenn. with research facilities in Netanya, Israel.