Moximed’s MISHA™ Knee System Achieves Superiority of Primary Endpoint in Pivotal Study

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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.

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Thursday, September 22, 2022
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Medical Devices, Health, Other Health, Physical Therapy, Research, Science, Sports medicine, Anterior cruciate ligament injury, KOOS, Walking, Safety, Trial of the century, HTO, Department, OSET, Hospital, IDE, University of Virginia, Osteoarthritis, WOMAC, Patient, Physician, Journal of Orthopaedic Research, Pain, Quality of life, Standard of care, Osteotomy, Surgeon, Hospital for Special Surgery, Chitranjan Singh Ranawat, Leadership, Â, ISA, University, Orthopaedic Research Society, HSS, OA, Dentistry, Medical imaging, Medical device, Shipbuilding, Knee, MD
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CALIFORNIA, UNITED STATES, NORTH AMERICA, BOSTON, NEW YORK
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MOXIMED, THE MISHA™ KNEE SYSTEM
Summary
Key Points: 
  • 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.
  • Over 90% of the patients receiving the MISHA Knee System experienced substantial, clinically meaningful pain relief and functional improvement.
  • In Dr. Diduchs data presentation of the Calypso Study, the MISHA Knee System met its primary endpoint and was found to be superior to high tibial osteotomy at two years.


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.

In Dr. Diduch’s data presentation of the Calypso Study, the MISHA Knee System met its primary endpoint and was found to be superior to high tibial osteotomy at two years. The MISHA Knee System demonstrated an 85.6% composite success rate compared to that of HTO (65.5%). Moximed’s ISA continued to demonstrate superiority on all secondary endpoints including the time to full weight bearing and improvement of Knee injury and Osteoarthritis Outcome Score (KOOS)-derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function scores at three months and at 24 months.

“In our IDE study, the MISHA Knee System was compared to the high standard set by high tibial osteotomy, a well-established orthopedic procedure. To demonstrate superiority against an established procedure, with proven results, is a great outcome for patients,” said Anton Clifford, Ph.D., Moximed CEO. “I’m delighted Dr. Diduch was invited to present these excellent data on behalf of the entire study team.”

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.

“The case scenario discussed at OSET of a young and active person with consistent chronic knee pain provided an ideal opportunity to discuss the importance of joint unloading to relieve pain, improve function, and preserve future treatment options. This implantable shock absorber yields several potential benefits including complete joint preservation, the lack of device-imposed restrictions on weight bearing, and early return to activity. Specifically, the MISHA Knee System reduces knee load by over 30% with every walking step1,” said Andreas H. Gomoll, MD, Hospital for Special Surgery (HSS) in New York.

The hosted symposium, 1st Implantable Shock Absorber for Unloading the Knee: Case Conversations with Experienced Surgeons and Clinical Study Patients, further emphasized the potential of the MISHA Knee System to improve the lives of those with knee OA. A growing number of study patients have now benefitted for over five years from an earlier version of the implantable shock absorber treatment. Case history review and patient discussions illustrated how pain relief and functional improvement translated to real-world benefits in work productivity, athletic activity, and family 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 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.2

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1 Morgan O et al. Effects of a Medial Knee Unloading Implant on Tibiofemoral Joint Mechanics During Walking. Journal of Orthopaedic Research. 2019. DOI 10.1002/jor.24379.

2 Morgan OJ, Hillstrom HJ, Ranawat A, Fragomen AT, Rozbruch SR, Hillstrom R. Effects of a Medial Knee Unloading Implant on Tibiofemoral Joint Mechanics During Walking. J Orthop Res. 2019;37(10):2149-2156. doi:10.1002/jor.24379.

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