Hyalex Orthopaedics announced today that patients successfully received knee implants as part of its first-in-human clinical trials.
The procedures came as part of two prospective, studies for the Hyalex Knee Cartilage System in the U.S. and Europe. Sites for both studies already enrolled and treated patients with the synthetic cartilage technology. The technology has FDA investigational device exemption as well.
Lexington, Massachusetts-based Hyalex designed the cartilage to replicate the structure and function of hyaline cartilage of the joints. It incorporates components that provide both strength and lubrication to replace painful cartilage lesions and immediately restore the knee surface. The technology matches the strong and slippery properties of the body’s native cartilage.
The company said its unique design allows surgeons to treat patients with or without bony involvement. Following implantation in the trials, investigators will regularly assess patients with imaging, physical exams and patient-reported outcome measures.
“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 CEO of Hyalex. “Our preclinical evaluations and testing of the Hyalex Knee Cartilage System have demonstrated the impressive resilience and durability of this technology. 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.”
