Gilde Healthcare company Moximed reports treatment of first commercial patients post FDA approval - Gilde Healthcare

Gilde Healthcare company Moximed reports treatment of first commercial patients post FDA approval

6. September 2023
Fremont, Calif. (USA)

Implantable shock absorber (ISA) relieves pain and improves function in people ineligible for, or unwilling to undergo, joint replacement

Multiple surgeons from multiple U.S. centers treat patients with knee osteoarthritis

Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced the first commercial cases of the MISHA™ Knee System, an implantable shock absorber (ISA) for the knee. The FDA-cleared MISHA Knee System is indicated to treat people with medial knee OA who failed to find relief from non-surgical or surgical treatment, continue to experience pain that interferes with daily activities, and are ineligible for, or unwilling to undergo, joint replacement due to age or absence of advanced OA.
Osteoarthritis is the most prevalent joint disease with knee OA accounting for more than 80 percent of the disease’s total burden and affecting at least 19 percent of American adults aged 45 years and older. Until the MISHA Knee System became available in April 2023, physicians and many patients had limited treatment options when conservative treatments failed.

“We’ve had unsolicited online requests for access to the MISHA Knee System from over one hundred surgeons across the U.S., and we receive several online patient inquiries every day,” said Anton Clifford, Ph.D., founder and CEO of Moximed. “Despite this broad enthusiasm, our roll out plan remains focused on delivering high quality education to our surgeon users, and I’m delighted to see our first surgeons represent both top-tier academic centers and high-caliber private practices.”

Dennis C. Crawford, M.D., Ph.D., Professor of Orthopaedics and Rehabilitation, School of Medicine, Oregon Health and Science University, treated the first commercial patient. “I am honored to have treated the first MISHA patient. My first patient, in his 40s, presented with medial meniscal pathology, significant medial knee pain, and mild joint space loss. Prior to the MISHA Knee System being available, I had no good options for this patient. At the two-week post-operative visit, he had already recovered full range of motion, was fully weight bearing, and was walking comfortably,” said Dr. Crawford. “This outcome is consistent with the pivotal study results, and I now look forward to including the MISHA Knee System as a regular part of my treatment algorithm.”

“I referred a patient of mine to a previous clinical study, and I saw firsthand how an implantable shock absorber can meet a real unmet need in my practice,” said Sabrina Strickland, M.D., Hospital for Special Surgery, New York. “My first MISHA case was a 47-year-old female with painful, early OA and a meniscal root tear. The ability to reduce compartment loads with the ISA and concomitantly repair the root without having to cut bone is a significant step toward the goal of providing long term joint preservation. I’m excited to offer this treatment to many OA patients who might benefit from a joint unloading procedure and who demand a shorter path to recovery or the potential for high activity.”

In addition to Drs. Crawford and Strickland, cases were completed by David Diduch, M.D., University of Virginia, Charlottesville, VA, Justin Saliman, M.D., Precision ASC, Beverly Hills, CA, and Andreas Gomoll, M.D., Hospital for Special Surgery (HSS), NY, NY.

Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation. Many people with mild to moderate OA are otherwise healthy, in their prime working years, and have busy lives to live. For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease. OA patients without end-stage disease seek options that preserve their knee, activity level, and quality of life.

About Moximed
Moximed was founded in 2008 and is dedicated to helping people with mild to moderate osteoarthritis preserve their knee joints while living healthy, active lives. The company’s technology, the MISHA™ Knee System, is the result of over a decade of clinical research and development and is the first implantable shock absorber for the treatment of medial compartment knee osteoarthritis (OA). With experienced medtech leadership and strong investor support, Moximed is poised to elevate the standard of care and quality of life for millions of pre-arthroplasty knee OA sufferers hindered by arthritic knee pain and function loss. Moximed is based in Fremont, California.To learn more, visit www.moximed.com.

About The MISHA™ Knee System
Reducing weight on painful osteoarthritic joints is known to reduce pain and improve function. The MISHA™ Knee System is the first implantable shock absorber that reduces weight on the knee joint with every walking step, easing pain, preserving function, and possibly delaying joint replacement surgery. The implant is placed on the medial knee and moves with the natural joint, reducing about 30% of the peak force on the knee with every walking step.

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