Hyalex Orthopaedics’ supplemental investigational device exemption (IDE) application has received approval from the US Food and Drug Administration (FDA) for a clinical trial of its HYALEX Freestyle Knee Implant.
This approval will expand the company’s early feasibility study (EFS) of the knee technology into a pivotal trial.
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The Freestyle Knee Implant is engineered to help individuals regain an active lifestyle by addressing cartilage damage and early osteoarthritis of the femoral condyles.
The upcoming trial will be carried out at various orthopaedic centres in the US and Europe, focusing on assessing the device’s effectiveness and safety in restoring mobility and enhancing the outcomes of the individuals.
A diverse subject population, which at present has limited treatment options, is expected to be enrolled in the trial.
Hyalex Orthopaedics CEO Carl Vause said: “This FDA approval validates the rigorous research and development behind our Freestyle Knee Implant and propels us into the next phase of clinical evaluation.
“We are committed to advancing orthopaedic care by delivering innovative solutions that address the unmet needs of cartilage gap patients, which is estimated to represent a $2bn market in the US alone.”
The trial will leverage the encouraging clinical outcomes observed in the EFS of the implant, as noted by the study’s national principal investigator, Dr Sabrina Strickland from the Hospital for Special Surgery, US
Dr Strickland said: “In our early clinical evaluations, the HYALEX Freestyle Knee Implant demonstrated exceptional promise in mimicking natural joint mechanics and helping patients return to their active lifestyle.”
Hyalex develops joint preservation solutions intended for damaged and diseased joints. The company’s HYALEX HYDROSURF materials platform has over 17 patents and trademarks globally.
