SUN Clinical Trial to Enroll Patients with Persistent Knee Pain at up to 20 Sites Nationwide
MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants today announced that it has initiated its second clinical trial evaluating the investigational NUsurface® meniscus implant. The SUN (Safety Using NUsurface) trial will enroll approximately 120 patients with persistent knee pain caused by injured or deteriorating meniscus cartilage at up to 20 sites nationwide. NUsurface is an investigational meniscus replacement being evaluated as a treatment option to help patients delay or avoid total knee replacement.
The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.
“A damaged meniscus has a very limited healing potential, oftentimes leading to knee replacement surgery,” said Henry Klyce, chief executive officer of Active Implants. “There is an unmet need in the orthopedic market for a treatment option – such as the investigational NUsurface Meniscus Implant – that can fill the gap between minimally invasive meniscus repair and total knee replacement.”
The following orthopedic centers are or will soon be recruiting patients, and additional sites will be added as needed:
- Phoenix, Arizona – TOCA, The Orthopedic Clinic Association – Tom Carter, MD
- Long Beach, California – Memorial Orthopaedic Surgical Group – Peter Kurzweil, MD
- San Francisco, California – St Mary’s Medical Center – William Montgomery, MD
- Boulder, Colorado – Colorado University Sports Medicine – Eric McCarty, MD
- Denver, Colorado – Advanced Orthopedics & Sports Medicine Specialists – Wayne Gersoff, MD
- Baton Rouge, Louisiana – Baton Rouge Orthopaedic Clinic – Robert Easton, MD
- New Orleans, Louisiana – Ochsner Sports Medicine Institute – Deryk Jones, MD
- Portland, Oregon – Oregon Sports Medicine – John Greenleaf, MD
- Arlington, Texas – Baylor Orthopedic and Spine Hospital – Joseph Berman, MD
- Salt Lake City, Utah – Salt Lake Regional Medical Center – Andrew Cooper, MD
All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.
Active Implants is also sponsoring the VENUS Study (Verification of the Effectiveness of the NUsurface® System), which has been underway at 10 sites in the U.S. since January 2015. Both the SUN and VENUS studies are being conducted to obtain regulatory approval from the U.S. Food & Drug Administration (FDA) to sell the device in the U.S.
About the NUsurface® Meniscus Implant
In the U.S., the NUsurface® Meniscus Implant (pronounced “new surface”) from Active Implants LLC is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and Israel since 2011.
About Active Implants LLC
Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use