The company is currently running the two prospective, multi-center, single-arm studies in the U.S. and Europe, with sites for both studies having already enrolled and treated patients.
HYALEX Cartilage is engineered to replicate the structure and function of hyaline cartilage, the strong and flexible tissue that enables the smooth and pain-free movement of your joints. By incorporating components that provide both strength and lubrication, HYALEX Cartilage is designed to replace painful cartilage lesions and provide immediate restoration of the knee surface by matching the strong and slippery properties of the body's native cartilage.
The HYALEX Knee Implant leverages this innovation to offer a potentially disruptive treatment approach for knee cartilage repair as compared to traditional orthopaedic materials.
The ongoing clinical trials (NCT06368700 and NCT06344481) are evaluating the safety and technical performance of the HYALEX Knee Cartilage System in symptomatic patients who require surgical treatment due to loss of articular cartilage in the knee femoral condyle. The unique design of the HYALEX Knee System allows surgeons to treat patients with or without bony involvement. Following implantation, study investigators will regularly assess patients with imaging, physical exams, and patient-reported outcome measures.
Active sites in the U.S. study include Oregon Health & Science University (OHSU) in Portland, Oregon, and the Hospital for Special Surgery (HSS) in New York. In Europe, investigational sites at the SPORTO Clinic in Lodz, Poland, and the Enel-Sport Center for Orthopedics and Rehabilitation in Warsaw, Poland, are screening and enrolling patients.
"Initial assessments of the Hyalex patients I have treated suggest that they are responding positively to the implant procedure and recovering very well. These are very promising results for cartilage patients at this stage of their treatment journey," said Professor Marcin Domzalski, Head of SPORTO Clinic and Chief of Orthopaedics and Trauma at the University of Lodz.
"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," said Carl Vause, President and Chief Executive Officer of 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. The initiation of these studies is a critical step on the path to providing Hyalex technology to orthopaedic surgeons, allowing them to treat these currently untreated patients."
About Hyalex Orthopaedics:
Hyalex is a privately held medical device company headquartered in Lexington, MA, developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. HYALEX Cartilage is protected by more than 17 patents and trademarks worldwide.
The HYALEX Cartilage platform has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration for a clinical trial in the United States. Hyalex is currently conducting clinical studies of HYALEX Cartilage for knee cartilage repair in both the U.S. and Europe.
For more information: www.hyalex.com
