Moximed’s MISHA™ Knee System achieves superiority in primary endpoint in pivotal study

Implantable shock absorbers demonstrate clinical pain relief and functional improvement in data presented in OSET

September 23, 2022

Fremont, California – (work wire) –moximeda medical device company on a mission to improve the standard of care for people with chronic knee pain due to osteoarthritis (OA), today announced clinical results presented in 12The tenth Summit of Orthopedic Surgery (OSET) in Boston.

Presented by David R. Deeduch, MD, AF Fuschel Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, results from the Calypso Pivotal Study of the MISHA™ Knee System, an Implantable Shock Absorber (ISA) for the treatment of the knee in the spine. 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 regimen.

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

The Calypso Study, a prospective, multicenter clinical study in 81 people, evaluated the safety and efficacy of the MISHA knee system, compared to a 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 over elevated tibial osteotomy. Over 90% of patients who received the MISHA Knee System experienced significant and clinically meaningful pain relief and improvement “Without cutting the bone or permanently modifying the joint, patients with knee osteoarthritis may soon have a treatment option that allows them to return to their active lives,” said David R. Didoch, MD, of the University of Virginia.

In the data presentation Dr. Didoch provided for the Calypso study, the MISHA Knee System achieved its primary end point and was found to be superior to tibial elevation osteotomies within two years. The MISHA knee system showed a compound success rate of 85.6% compared to HTO (65.5%). Moximed’s ISA criterion continued to demonstrate superiority over all secondary endpoints including time to full weight bearing, improvement in knee injury, osteoarthritis outcome (KOOS) scores – derived from the 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 standards defined by tibial osteotomy, a well-established orthopedic procedure. Proving superiority over an established procedure, with proven results, is a great result,” said Anton Clifford, PhD, CEO of Moximed. Patients: “I am pleased that Dr. Deeduch has been invited to present this excellent data on behalf of the entire study team.”

Unloading the joint is a well-known mechanism of pain relief among clinicians and patients with osteoarthritis of the knee. The MISHA Knee System uses this well-established mechanism along with familiar orthotic materials to achieve positive results. The MISHA Knee System has the potential to delay joint replacement in some patients, and Andreas H. Gomol, MD, Hospital of Special Surgery (HSS) in New York, presented data from previous versions of the device showing a positive five-year arthroplasty free. rates.

“The case scenario discussed in OSET for a young, active person with chronic knee pain provides an ideal opportunity to discuss the importance of emptying the joint to relieve pain, improve function, and preserve future treatment options. Implantable shock absorbers result in many potential benefits including complete preservation on the joint, no device-imposed restrictions on weight bearing, and an early return to activity.Specifically, the MISHA Knee System reduces knee load by more than 30% with each walking step1,” said Andreas H. Gomol, MD, Hospital of Special Surgery (HSS) in New York.

hosted seminar, The First Implantable Shock Absorber for Knee Discharge: Case Conversations with Experienced Surgeons and Clinical Study Patients, further emphasized the ability of the MISHA Knee System to improve the lives of those with knee osteoarthritis. An increasing number of study patients have now benefited for more than five years from an earlier version of the implantable shock absorber therapy. A review of the case history and patient discussions showed how pain relief and functional improvement translated into real-world benefits in work productivity, sports activity, and family life.

About Moximed

Moximed was founded in 2008 and is dedicated to helping people with mild to moderate osteoarthritis maintain their knee joints while living healthy and active lives. The company’s technology, the MISHA™ Knee System, is the first implantable shock absorber for the treatment of osteoarthritis of the knee (OA). Led by Medtech’s experienced leadership and funding in excess of $150 million, Moximed is poised to bring MISHA to market and raise the standard of care and quality of life for the millions of people suffering from knee pain caused by osteoarthritis and loss of function. Moximed is headquartered in Fremont, California.

ABOUT MISHA knee system

Losing weight on painful osteoarthritis joints is known to reduce pain and improve function. miss The knee system being developed is the first implantable shock absorber that reduces weight on the knee joint with every walking step, relieves pain, preserves function, and potentially delays joint replacement surgery. The implant is placed over the middle knee and moves with the natural joint, reducing peak forces on the knee by more than 30% with each walking step.2

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1 Morgan and others. Effects of a medial knee unloading implant on the mechanics of the femur joint during walking. Journal of Orthopedic 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 discharge implant on the mechanics of the Tibiofemoral joint while walking. J Orthop Res. 2019; 37 (10): 2149-2156. doi: 10.1002/jor.24379.

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Anika Parish
Health + Trade
annika@healthandcommerce.com

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