Gilde Healthcare portfolio company Moximed’s MISHA™ Knee System Achieves Superiority of Primary Endpoint in Pivotal Study - Gilde Healthcare

Gilde Healthcare portfolio company Moximed’s MISHA™ Knee System Achieves Superiority of Primary Endpoint in Pivotal S...

September 23, 2022
Utrecht (the Netherlands) & Fremont, Ca. (US)

Implantable shock absorber demonstrates clinically meaningful pain relief and functional improvement in data presented at OSET

Moximed, a medical device company on a mission to improve the standard of care for people suffering with chronic knee pain due to osteoarthritis (OA), today announced clinical results presented at the 12th Orthopaedic Summit (OSET) in Boston.

David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, presented results from the pivotal Calypso Study of the MISHA™ Knee System, an implantable shock absorber (ISA) for the treatment of knee osteoarthritis. The Calypso Study demonstrated superiority of its primary endpoint and reported clinically significant reduction in pain scores and improvement in function scores for participants receiving the MISHA Knee System.

Designed to relieve pain, preserve function, and offer a treatment option that could potentially delay arthroplasty, the MISHA Knee System is an implantable shock absorber developed to unload on the knee with every walking step.

The Calypso Study, a prospective and multicenter clinical study which enrolled 81 subjects, evaluated the safety and effectiveness of the MISHA Knee System, compared to high tibial osteotomy (HTO), when used to treat symptomatic osteoarthritis of the medial compartment of the knee.

“These clinical findings are exciting because they demonstrate that the joint-preserving implantable shock absorber has the potential to provide significant benefits compared to high tibial osteotomy. Over 90% of the patients receiving the MISHA Knee System experienced substantial, clinically meaningful pain relief and functional improvement. Without cutting bones or permanently modifying the joint, patients with knee OA may soon have a treatment option that allows them to return to their active lives,” said David R. Diduch, MD, University of Virginia.

Joint unloading is a well-known mechanism for pain relief among physicians and patients with knee OA. The MISHA Knee System utilizes this established mechanism in combination with familiar orthopedic materials to generate positive results. The MISHA Knee System has the potential to delay joint replacement in certain patients, and Andreas H. Gomoll, MD, Hospital for Special Surgery (HSS) in New York, presented data of earlier versions of the device showing positive five-year freedom from arthroplasty rates.

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 first implantable shock absorber for the treatment of medial compartment knee osteoarthritis (OA). With experienced medtech leadership and financing exceeding $150 million, Moximed is poised to bring MISHA to market and elevate the standard of care and quality of life for millions of people hindered by arthritic knee pain and function loss. Moximed is based in Fremont, California.

About The MISHA Knee System
Reducing weight on painful osteoarthritic joints is known to reduce pain and improve function. The MISHA Knee System being developed 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 peak forces on the knee by over 30% with every walking step.

About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor with two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in fast growing, innovative companies active in (bio)pharmaceuticals, healthtech and medtech that are based in Europe and North America. For more information, please visit: www.gildehealthcare.com.

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