Moximed Wins CE Mark and First Commercial Use of AtlasTM Knee System

Moximed Announces CE Mark and First Commercial Use of AtlasTM Knee System

Shock absorber for the knee designed to treat patients with medial knee osteoarthritis (OA)

HAYWARD, Calif.--(BUSINESS WIRE)--

Moximed^®, Inc. announced the CE Mark of the Atlas Knee System, its next-generation knee joint unloader for pre-arthroplasty patients. Coinciding with the CE Mark, the first commercial uses of the product occurred in Europe.

Joint unloading is a proven therapy that has recently become more common as the need for alternatives to end-stage joint replacement becomes more evident. Between 1990 and 2010, the incidence of symptomatic knee OA skyrocketed, particularly among patients 35 – 65 years of age.¹ First performed in the 1960’s, knee joint replacement has provided benefit for many patients, but its suitability for active adults of the 21st century is coming under increasing clinical scrutiny. Recent studies show that younger or active patients experience higher reoperation rates and higher levels of residual pain and dissatisfaction.^2,3 The Atlas System is specifically designed for patients wishing to preserve both their knee and their lifestyle.

“We are proud to have implanted the first CE Marked Atlas Systems worldwide,” stated Claudio Zorzi, MD, of Ospedale Sacro Cuore Don Calabria in Negrar (Verona), Italy. “The Atlas System provides the same amount of joint unloading as the previous generation device, but it now offers a smaller device footprint and a surgical technique customized to the patient’s own anatomy. We anticipate the Atlas System will be used for a significant portion of our knee practice.” Dr. Zorzi and his associate, Vincenzo Madonna, MD, have the largest worldwide experience with Moximed’s earlier generation joint unloader.

The Atlas System design was evaluated in a 40 patient, prospective, multi-center clinical study. One of the study investigators, Konrad Slynarski, MD, of Lekmed Szpital in Warsaw, Poland commented, “My practice treats many young, active patients with mild osteoarthritis. I was amazed at the overwhelming patient interest in receiving joint unloading therapy, and I was very happy with my patients’ consistently rapid recovery and return to daily activities. I have already shifted my practice patterns to offer the Atlas System to patients.”

Another of the investigators in the study was Willem van der Merwe, MD, FCS (SA) of the Sports Science Orthopaedic Clinic in Cape Town, South Africa, who noted, “I enrolled my full allotment into the study and could have enrolled additional subjects. I believe the Atlas System could be a pre-arthroplasty treatment solution for people who are too young or not ready for joint replacement, and I look forward to adding the service as a regular part of my practice.”

“We are pleased with the early clinical results and surgeon interest in the Atlas System,” stated Moximed CEO Kevin Sidow. “Building on our seven years of clinical experience with joint unloading, we are confident that the Atlas System will make a positive impact for osteoarthritis patients worldwide. We believe the Atlas System provides a significant segment of osteoarthritis sufferers the joint preserving option that will allow them to live the highly active lives that they expect and deserve.”

About Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to the Centers for Disease Control and Prevention (CDC), OA affects 27 million adults in the US. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain.

About Moximed

Moximed, Inc. is dedicated to improving the standard of care for patients with osteoarthritis (OA). OA, the most common form of arthritis, leads to a breakdown of the joint’s cartilage and often results in joint pain and loss of motion. Moximed is supported by world-leading venture investors including New Enterprise Associates (NEA), Vertex Venture Holdings Ltd., Gilde Healthcare Partners, Morgenthaler Ventures, and GBS Venture Partners. More information can be found at www.moximed.com.

About the Atlas System

The Atlas System is an implantable joint unloader for patients with medial knee osteoarthritis. Placed subcutaneously alongside the knee joint, the Atlas System incorporates advanced biomaterials designed to provide a clinically beneficial 13 kg of unloading. Importantly, the Atlas System absorbs excess joint load rather than transfer load to otherwise healthy areas of the joint. The Atlas System features a streamlined surgical technique based on the patient’s own anatomy and allows the surgeon to visually confirm that functional joint unloading is achieved. Finally, the Atlas System is a joint preserving, reversible procedure, meaning that patients have future treatment options available to them should their osteoarthritis become more severe.

The Atlas is CE Marked in Europe and is currently only being made available to select centers. It is not approved for sale in the United States.

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¹ Medtech Insight: Knee OA: Growing Demand for Non-surgical Options, 2011.

² Meehan et al. Younger Age is Associated with a Higher Risk of Early Periprosthetic Joint Infection and Aseptic Mechanical Failure After TKA. J Bone Joint Surg Am. 2014;96:529-35.

³ Parvizi et al. High level of residual symptoms in young patients after total knee arthroplasty. Clin Orthop Relat Res 2014;472:133-7.

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• joint replacement