Results from Multi-center, Prospective Study with Unicompartmental Joint Unloading Device for the Knee Presented at ESSKA
Moximed Commercializing Atlas System in Europe
HAYWARD, Calif. – Moximed®, Inc. announced today the first clinical data presentations for its Atlas System, a unicompartmental joint unloading device for pre-arthroplasty knee osteoarthritis (OA) patients. The data, presented at the 17th ESSKA Congress in Barcelona, Spain, revealed that patients with the Atlas System experienced effective pain relief, regained range of motion, and returned to normal activity levels within several weeks. The Atlas System obtained CE Mark at the end of 2015, and the company is in the early phases of introducing the product to European customers.
“We are seeing increasing numbers of younger patients with knee osteoarthritis who are looking for pain relief and the ability to get back to their active lifestyles,” explained Robert Smigielski, M.D., of the Carolina Clinic in Warsaw, Poland, and a team doctor for the Polish Olympic team. “The data from our study show that these patients could benefit from the Atlas System and its joint unloading and joint preserving approach.”
Data from a 26 patient prospective, multi-center study presented at ESSKA demonstrated that the Atlas System provides rapid, clinically effective pain relief and an excellent safety profile for patients with early knee OA in the pre-arthroplasty stage of their disease. WOMAC pain and functions scores improved from 53 ± 8 and 48 ± 17 at baseline to 17 ± 16 and 21 ± 17 at six months, respectively (lower scores represent improvement). 92% of patients experienced a clinically meaningful improvement on their WOMAC pain score, defined as a 10-point absolute improvement. Knee Society Pain and Function Scores improved from 62 ± 15 and 73 ± 14 at baseline to 91 ± 10 and 98 ± 4 at six months, respectively. Patients regained baseline range of motion (130 degrees) by 6 weeks to 3 months and returned to high impact activity levels, including basketball and running.
Previous studies have correlated degenerative meniscal pathology with articular cartilage changes and signs of early OA. During ESSKA, Konrad Slynarski, M.D., Ph.D., of Lekmed Szpital in Warsaw, Poland presented his experience treating patients with early OA associated with a repetitive overload condition, such as degenerative meniscus, cartilage defects, and bone marrow edema. Eighteen consecutive patients were enrolled and achieved improvement in WOMAC pain scores from 53 ± 15 at baseline to 19 ± 15 at six months (p<0.001).
“These are very promising results from a study that uniquely considered early OA, such as degenerative meniscal pathology and cartilage changes, in the included population,” explained Dr. Slynarski. “Patients with a degenerative meniscus and early OA often experience a recurrence of symptoms only months after meniscectomy, and now they have a pre-arthroplasty treatment option to consider.”
In a third presentation, Priv. Doz. Dr. med. Christoph Becher, a surgeon with the ATOS Klinik Heidelberg and an Associate Professor at Hannover Medical School, revealed data from an in vitro biomechanics study demonstrating that the 13 kg of unloading by the extra-capsular absorber reduces peak contact pressure by up to 30%.
Additionally, several other researchers presented data on Moximed unicompartmental unloading implants at ESSKA:
- Willem van der Merwe, M.D., FCS (SA) of the Sports Science Orthopaedic Clinic in Cape Town, South Africa, summarized the positive results of a 40 patient feasibility study of the Atlas System design.
- Professor Mike McNicholas, M.D., FCRS of Aintree University Hospital, UK, presented a five-year survival analysis of a previous generation implantable joint unloader (KineSpring® System) on behalf of Australian researchers David Hayes, M.D., FRACS and Associate Professor Craig Waller, M.D., FRACS.
- Fabio Sciarretta, M.D., of the Clinica Nostra Signora della Mercede in Rome, Italy presented his mid-term results of the KineSpring System.
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 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.
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.
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