Hyalex Orthopaedics has reported treatment of first patients with the company’s Hyalex Knee Cartilage System as part of its first-in-human clinical trials.
The American medical device company is engaged in developing cartilage repair products based on its Hyalex materials platform.
Presently, Hyalex Orthopaedics is carrying out two prospective, multi-centre, single-arm studies in the US and Europe. Sites for both trials have already recruited and treated patients.
The two clinical trials are assessing the safety and technical effectiveness of the Hyalex Knee Cartilage System in symptomatic patients necessitating surgical intervention due to the loss of articular cartilage in the knee femoral condyle.
Hyalex Cartilage has been designed to mimic the structure and functionality of hyaline cartilage, a resilient tissue essential for facilitating seamless and painless joint movement.
Through the integration of components that offer both strength and lubrication, the system aims to address painful cartilage lesions and promptly restore the knee surface by mirroring the robust and smooth characteristics of the body’s natural cartilage.
According to Hyalex Orthopaedics, the distinctive design of the HYALEX Knee System enables surgeons to address patients with or without bony involvement.
After implantation, study investigators will conduct regular assessments using imaging, physical examinations, and patient-reported outcome measures.
Active sites participating in the US study include Oregon Health & Science University (OHSU) in Portland, Oregon, and the Hospital for Special Surgery (HSS) in New York.
In Europe, investigational sites such as the SPORTO Clinic in Lodz and the Enel-Sport Center for Orthopedics and Rehabilitation in Warsaw, both located in Poland, are screening and registering patients.
Hyalex Orthopaedics president and CEO Carl Vause said: “An off-the-shelf surgical solution for cartilage repair is the largest unmet need in orthopaedics today. Market studies indicate that there are approximately 750,000 cartilage injuries diagnosed annually in the US that could be addressed by Hyalex.
“Our preclinical evaluations and testing of the HYALEX Knee Cartilage System have demonstrated the impressive resilience and durability of this technology. The quality of this data and our rigorous test methods were validated with the full FDA IDE approval of the US study.”
