Sam Brusco, Associate Editor04.22.24
Hyalex Orthopedics announced the first successful Hyalex knee implantation procedures in its first-in-human trials of the Hyalex knee cartilage system.
The company is currently conducting two studies in the U.S. and Europe. Both sites have already enrolled and treated patients.
Hyalex cartilage replicates hyaline cartilage’s structure and function. Hyaline cartilage is the strong, flexible tissue that allows joints to have smooth and pain-free movement.
The cartilage uses components that offer strength and lubrication to replace painful cartilage lesions. It offers immediate knee surface restoration by mimicking the strong, slippery properties of native cartilage. The Hyalex knee implant, according to the company, is a potentially disruptive treatment approach for knee cartilage repair compared to traditional orthopedic materials.
The two ongoing trials are evaluating the knee cartilage system in symptomatic patients who need surgical treatment because of articular cartilage loss in the knee’s femoral condyle. After implantation, investigators will regularly assess patients with imaging, physical exams, and patient-reported outcomes measures.
"An off-the-shelf surgical solution for cartilage repair is the largest unmet need in orthopedics today. Market studies indicate that there are approximately 750,000 cartilage injuries diagnosed annually in the US that could be addressed by Hyalex," said Hyalex president and CEO Carl Vause. "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 U.S. study. The initiation of these studies is a critical step on the path to providing Hyalex technology to orthopedic surgeons, allowing them to treat these currently untreated patients."
The company is currently conducting two studies in the U.S. and Europe. Both sites have already enrolled and treated patients.
Hyalex cartilage replicates hyaline cartilage’s structure and function. Hyaline cartilage is the strong, flexible tissue that allows joints to have smooth and pain-free movement.
The cartilage uses components that offer strength and lubrication to replace painful cartilage lesions. It offers immediate knee surface restoration by mimicking the strong, slippery properties of native cartilage. The Hyalex knee implant, according to the company, is a potentially disruptive treatment approach for knee cartilage repair compared to traditional orthopedic materials.
The two ongoing trials are evaluating the knee cartilage system in symptomatic patients who need surgical treatment because of articular cartilage loss in the knee’s femoral condyle. After implantation, investigators will regularly assess patients with imaging, physical exams, and patient-reported outcomes measures.
"An off-the-shelf surgical solution for cartilage repair is the largest unmet need in orthopedics today. Market studies indicate that there are approximately 750,000 cartilage injuries diagnosed annually in the US that could be addressed by Hyalex," said Hyalex president and CEO Carl Vause. "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 U.S. study. The initiation of these studies is a critical step on the path to providing Hyalex technology to orthopedic surgeons, allowing them to treat these currently untreated patients."