ZKR Orthopedics, Inc. 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.
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.
As part of its PELICAN IDE application, ZKR Orthopedics reported the following data from its first in human trial which evaluated the safety and efficacy of the LIFT implant in 18 patellofemoral cartilage degeneration patients enrolled in Warsaw, Poland and followed for 24 months.
- Overall reduction in patient reported pain from 68.6 at baseline to 26.2 at 24 months (62%) as measured by the Visual Analog Scale.
- Overall improvement in patient reported function from 55.3 at baseline to 71.0 at 24 months (28%) as measured by the Anterior Knee Pain Scale also known as the Kujala Scale.
- No patients progressed to partial or total knee replacement.
- There was no evidence of Patellar tendon necrosis or tendon structural damage
Patellofemoral cartilage degeneration is a common condition affecting approximately seven million Americans. The prevalence of this degenerative disease is driven by the common incidence of patella malalignment, as well as demographic factors including obesity. A growing body of clinical literature estimates that up to one third of all knee arthritis originates in the patellofemoral compartment. Symptoms include pain, swelling, loss of function, and stiffness. Patients tend to manifest patellofemoral cartilage degeneration symptoms during stair climbing, squatting, sitting and exercise.
The IDE approval announcement was made as part of the ZKR Orthopedics activities at the 2024 American Academy of Orthopedic Surgeons annual meeting in San Francisco. In addition to reporting IDE trial approval, the Company participated in the Canaccord Genuity Musculoskeletal Conference earlier this week. Additionally, ZKR team members will be introducing the LIFT technology to key opinion leaders at a cadaver laboratory held in San Francisco during the AAOS meeting.
For media inquiries or additional information, please contact:
ZKR Orthopedics, Inc.
info@zkrorthopedics.com
