Hyalex Orthopaedics received FDA approval of a supplemental Investigational Device Exemption (IDE) application for its Freestyle Knee Implant. This approval allows Hyalex to expand its Early Feasibility Study into a pivotal clinical trial of its novel knee implant technology.
Hyalex’s Freestyle Knee Implant is designed to enable patients with cartilage damage and early osteoarthritis of the femoral condyle(s) to regain an active lifestyle. The planned pivotal trial, which will be conducted at orthopedic centers across the United States and Europe, will evaluate the safety and effectiveness of the device in restoring mobility and improving patient outcomes. Study investigators intend to enroll a diverse patient population that currently has limited treatment options.
“This FDA approval validates the rigorous research and development behind our Freestyle Knee Implant and propels us into the next phase of clinical evaluation,” said Carl Vause, CEO of Hyalex. “We are committed to advancing orthopedic care by delivering innovative solutions that address the unmet needs of cartilage gap patients, which is estimated to represent a $2 billion market in the U.S. alone.”
Hyalex Orthopaedics received FDA approval of a supplemental Investigational Device Exemption (IDE) application for its Freestyle Knee Implant. This approval allows Hyalex to expand its Early Feasibility Study into a pivotal clinical trial of its novel knee implant technology.
Hyalex's Freestyle Knee Implant is designed to enable patients...
Hyalex Orthopaedics received FDA approval of a supplemental Investigational Device Exemption (IDE) application for its Freestyle Knee Implant. This approval allows Hyalex to expand its Early Feasibility Study into a pivotal clinical trial of its novel knee implant technology.
Hyalex’s Freestyle Knee Implant is designed to enable patients with cartilage damage and early osteoarthritis of the femoral condyle(s) to regain an active lifestyle. The planned pivotal trial, which will be conducted at orthopedic centers across the United States and Europe, will evaluate the safety and effectiveness of the device in restoring mobility and improving patient outcomes. Study investigators intend to enroll a diverse patient population that currently has limited treatment options.
“This FDA approval validates the rigorous research and development behind our Freestyle Knee Implant and propels us into the next phase of clinical evaluation,” said Carl Vause, CEO of Hyalex. “We are committed to advancing orthopedic care by delivering innovative solutions that address the unmet needs of cartilage gap patients, which is estimated to represent a $2 billion market in the U.S. alone.”
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