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ZKR Orthopedics Receives IDE Approval for Clinical Trial

SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial. The approved trial will evaluate the Company's LIFT implant to treat later stage patellofemoral cartilage degeneration in adult patients.

“The evidence provided by our first in human trial combined with the data from our pre-clinical work was sufficient to allow FDA to grant authorization to enroll the pivotal trial. We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use,” commented David Cash, CEO of ZKR Orthopedics. “I am incredibly proud of our team for accomplishing this milestone. The IDE approval, combined with our previously obtained Breakthrough Device Designation, positions the Company to increase awareness of the unmet need in the patellofemoral cartilage degeneration patient population.”

The PELICAN trial is designed as a prospective, propensity matched non-inferiority trial which will enroll approximately 245 patients at 24 sites in the U.S. and Europe. The treatment cohort will evaluate the performance of the LIFT implant in patients suffering from later stage cartilage degeneration of the patellofemoral compartment of the knee. These results will be compared to a control group consisting of similar patients receiving a tibial tubercle osteotomy. The primary composite endpoint consists of relevant patient reported outcomes, a safety evaluation, and radiographic confirmation. Both arms will collect data on secondary endpoints including pain, function, and speed of recovery. A rigorous imaging assessment will provide clinicians with a thorough evaluation of tendon safety.

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