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.

旧金山，2024年2月14日（环球通讯社）--ZKR Orthopedics，Inc.，一家临床阶段医疗器械公司，宣布其已获得美国食品和药物管理局（FDA）关于多中心前瞻性临床试验的研究性器械豁免（IDE）批准。批准的试验将评估该公司的LIFT植入物治疗成年患者晚期髌股软骨退变。

'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.

“我们的首次人体试验提供的证据以及我们临床前工作的数据足以使FDA授权参加关键试验。ZKR Orthopedics首席执行官戴维·卡什（DavidCash）评论道：“我们预计这项试验收集的数据将为LIFT植入物的临床使用批准奠定强有力的临床证据基础。”。

“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.

“我为我们的团队实现这一里程碑感到无比骄傲。IDE的批准，再加上我们之前获得的突破性设备指定，使公司能够提高对髌股软骨退化患者群体未满足需求的认识。”鹈鹕试验是一项前瞻性，倾向匹配的非劣效性试验，将招募appr在美国的24个地点大约有245名患者。

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.

和欧洲。治疗队列将评估LIFT植入物在患有膝关节髌股关节室晚期软骨退化的患者中的表现。将这些结果与由接受胫骨结节截骨术的类似患者组成的对照组进行比较。

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 r.

主要复合终点包括相关患者报告的结果，安全性评估和影像学确认。双臂将收集次要终点的数据，包括疼痛，功能和r的速度。