Moximed Initiates US Clinical Study with KineSpring® System in Patients with Knee Osteoarthritis - Gilde Healthcare

Moximed Initiates US Clinical Study with KineSpring® System in Patients with Knee Osteoarthritis

December 11, 2012

Moximed, Inc. announced today that the KineSpring® System, an implantable medical spring that works by unloading the weight on the diseased knee joint, has been successfully implanted in the first patient enrolled in its US clinical study, SOAR.

This prospective, single-arm clinical study of the KineSpring System in patients with medial compartment knee osteoarthritis will enroll a total of 30 patients at six leading orthopaedic centers across the United States. The study’s Lead Principal Investigator is Jack Farr, M.D., Director of the OrthoIndy Cartilage Restoration Center of Indiana and the OrthoIndy Sports Medicine Fellowship Program. The objectives of the study are to evaluate the safety and effectiveness of the KineSpring System for the treatment of knee OA in a US patient group.

“Previous clinical experience with the KineSpring System in Europe and Australia has shown favorable results,” noted 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, who performed the first procedure in the United States in December 2012. “My Co-investigators and I are encouraged by this experience and believe the KineSpring System could prove to be an effective treatment option in active individuals, with early knee osteoarthritis, who are interested in a procedure that is less invasive than joint replacement surgery.”

“The start of the SOAR clinical trial with the KineSpring System is a significant milestone for Moximed. The KineSpring System is already commercialized in the major European markets, and we look forward to seeing the results and progressing with the product’s development in the US,” noted Kevin Sidow, President and CEO of Moximed.

About Osteoarthritis

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 that 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 250 osteoarthritis patients. It is only available in the US as part of the FDA approved SOAR Clinical Trial.

About Moximed

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.

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