Hyalex Orthopaedics has announced the successful treatment of the first patients in the first-in-human clinical trials with its HYALEX Knee Cartilage System.
The company’s two prospective, multi-centre, single-arm studies, NCT06368700 and NCT06344481, are being carried out in the US and Europe to evaluate the safety and technical performance of the HYALEX system for knee cartilage repair.
The clinical trials are being conducted at Oregon Health & Science University and the Hospital for Special Surgery in the US, as well as the SPORTO Clinic and the Enel-Sport Center for Orthopedics and Rehabilitation in Poland.
The HYALEX Knee Cartilage System is designed to mimic the structure and function of hyaline cartilage, the tissue that allows for smooth joint movement.
It aims to replace damaged cartilage lesions with a material that offers both strength and lubrication.
Patients enrolled in these two studies undergo regular assessments through imaging, physical exams, and patient-reported outcome measures.
Hyalex president and CEO Carl Vause said: "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.”
The HYALEX Knee Implant's unique design allows for the treatment of patients with varying degrees of cartilage damage, including those with or without bony involvement. This flexibility could position the HYALEX system as a disruptive technology in orthopaedic materials.
SPORTO Clinic head and University of Lodz orthopaedics and trauma chief Marcin Domzalski said: “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.”
Hyalex Orthopaedics’ cartilage system received the US Food and Drug Administration’s (FDA) breakthrough device designation in 2021.
