HAYWARD, California – Moximed®, Inc. announced today that enrollment has been completed in its US-based SOAR clinical study. Patients enrolled in the SOAR clinical study were treated with the KineSpring® System, an implantable medical spring that works by unloading weight in the knee joints of patients with osteoarthritis (OA).
Designed to evaluate safety and effectiveness, this prospective, single-arm clinical study enrolled a total of 30 patients with mild-to-moderate medial compartment knee osteoarthritis. Six leading orthopaedic centers across the United States participated in the study.
The study’s Lead Principal Investigator, Jack Farr, M.D., Director of the OrthoIndy Cartilage Restoration Center of Indiana and the OrthoIndy Sports Medicine Fellowship Program, commented,
“My medical practice has led me to become deeply involved in early intervention knee procedures, including cartilage restoration, knee realignment, and partial knee replacement. I found that there was still a large group of patients who were not optimal candidates for these treatment options. As a result, I sought out additional options for these patients and believe the KineSpring System may address their needs. Our center observed tremendous patient interest in the treatment, and if the outcomes of the SOAR clinical study match the experience from previous clinical studies of the device, the KineSpring System could become an effective treatment option for patients with early knee (medial compartment) osteoarthritis.”
The majority of the patients enrolled in the SOAR clinical study were treated on an outpatient basis. Principal Investigator Dennis C. Crawford, M.D., Ph.D., Associate Professor of Orthopedic Surgery and Director of Sports Medicine at Oregon Health & Science University in Portland, Oregon noted,
“Increased focus on resource efficiency, combined with the preservation of natural knee anatomy and potentially shorter hospitalization, make this an attractive potential treatment option for patients with medial knee osteoarthritis.” David Diduch, M.D., A. R. Shands Professor of Orthopaedic Surgery at the University of Virginia added, “The potential to perform the KineSpring procedure in an outpatient setting in an ambulatory surgical center could offer significant clinical and economic benefit.”
Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to the Centers for Disease Control and Prevention (CDC), OA affects 27 million adults in the US. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain. While drugs and certain cartilage repair procedures may temporarily relieve pain, they often do not treat the underlying problems that led to OA. Conversely, research suggests that if the excess stress on the joint is removed, as with the KineSpring System, pain may decrease and the natural joint tissues may demonstrate some recovery.
About the KineSpring System
The KineSpring System is intended to provide an innovative treatment option for patients with mild-to-moderate knee osteoarthritis who find conservative therapy, such as pain medication and knee braces, unsuccessful, but who are not ready for joint-altering knee surgery. The KineSpring System is implanted in the subcutaneous tissue alongside the joint to cushion the knee from excessive loading. Importantly, the KineSpring System is completely joint-sparing, so future treatment options are maintained.
The KineSpring System is CE marked in Europe and has been successfully implanted into more than 400 osteoarthritis patients. It is investigational in the US and only available in the US as part of the FDA approved SOAR clinical study.
Moximed Inc is dedicated to improving the standard of care for patients with osteoarthritis. OA, the most common form of arthritis, leads to a breakdown of the joint’s cartilage and often results in joint pain and loss of motion. OA commonly affects the knees, hips, hands, or back. Moximed is initially focused on developing minimally invasive, joint preserving solutions for patients with knee osteoarthritis. Moximed is supported by world-leading venture investors including New Enterprise Associates (NEA), Morgenthaler Ventures, Frazier Healthcare Ventures, Gilde Healthcare Partners, GBS Venture Partners. More information can be found at www.moximed.com.