Gilde Healthcare portfolio company Moximed obtains FDA Market Authorization of the MISHA™ Knee System for People Suffering from Knee Osteoarthritis - Gilde Healthcare

Gilde Healthcare portfolio company Moximed obtains FDA Market Authorization of the MISHA™ Knee System for People Suff...

13 april 2023
Utrecht (The Netherlands) & Fremont, Calif. (USA)
  • Implantable shock absorber (ISA) relieves pain and improves function in people ineligible for, or unwilling to undergo, joint replacement
  • MISHA Knee System is implanted during an outpatient procedure; it’s the first and only device of its kind for people with symptomatic knee OA 
  • More than 32 million people in the United States are affected by osteoarthritis

Gilde Healthcare portfolio company Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization of the MISHA™ Knee System, an implantable shock absorber (ISA) for the knee. The 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.

“This is a milestone event for knee OA sufferers, and it’s the result of unwavering clinical research and development that spans more than 10 years. We offer special thanks to our study patients and surgeon investigators who helped advance the understanding of this new treatment for OA. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. We’re thrilled to now be in a position to make the surgery available to patients,” said Anton Clifford, PhD, founder and CEO of Moximed. “We are committed to providing excellent medical education and customer service, supporting selection and treatment of indicated patients, and demonstrating scalability of our business as we introduce the MISHA Knee System to the U.S.”

Moximed utilized the clinically established benefits of load reduction on diseased joints to design the MISHA Knee System. Implanted during an outpatient-compatible procedure, the MISHA Knee System demonstrated superiority over high tibial osteotomy (HTO), a well-established surgery with decades of demonstrated clinical results, in its recent pivotal clinical study.

Osteoarthritis (OA) is a common, debilitating condition, affecting the lives of over 32 million adults in the U.S, and projected to impact 70 million Americans by 2040. 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 Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing over EUR 2.5B across two fund strategies: venture & growth capital and private equity. The Venture & Growth fund of Gilde Healthcare invests in fast growing companies active in medtech, digital health and therapeutics. The venture & growth companies are based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in North-Western Europe. For more information, visit the company’s website at www.gildehealthcare.com.

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 being developed 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.

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