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Hyalex Orthopaedics announced that patients have successfully received HYALEX Knee Implants as part of the company’s first-in-human clinical trials of its novel HYALEX Knee Cartilage System. 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. By incorporating components that provide both strength and lubrication, HYALEX Cartilage is designed to replace cartilage lesions and provide immediate restoration of the knee surface by matching the strong and slippery properties of the body’s native cartilage.
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 design of the HYALEX Knee System allows surgeons to treat patients with or without bony involvement.
“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.”
Source: Hyalex Orthopaedics
Hyalex Orthopaedics announced that patients have successfully received HYALEX Knee Implants as part of the company’s first-in-human clinical trials of its novel HYALEX Knee Cartilage System. 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...
Hyalex Orthopaedics announced that patients have successfully received HYALEX Knee Implants as part of the company’s first-in-human clinical trials of its novel HYALEX Knee Cartilage System. 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. By incorporating components that provide both strength and lubrication, HYALEX Cartilage is designed to replace cartilage lesions and provide immediate restoration of the knee surface by matching the strong and slippery properties of the body’s native cartilage.
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 design of the HYALEX Knee System allows surgeons to treat patients with or without bony involvement.
“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.”
Source: Hyalex Orthopaedics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
