CartiHeal Ltd, the developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, and two Louisiana State University Health orthopedic surgeons recently announced the successful enrollment of the first two U.S. patients in the Agili-C Federal Drug Administration Investigational Device Exemption (IDE) study.
First U.S. Patients Receive Agili-C Implants
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Agili-C is a cell-free, off-the-shelf implant that is CE marked for use in cartilage and osteochondral defects. Agili-C was implanted in a series of trials conducted in leading centers in Europe and Israel, in over 400 patients with cartilage lesions in the knee, ankle and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.
The first two cases in the United States were performed by principle investigator Vinod Dasa, M.D., associate professor and director of Orthopaedic Research, and Michael Hartman, M.D., associate professor of Orthopaedic Surgery at Louisiana State University Health New Orleans School of Medicine, on August 14, 2018.
The first patient that received an Agili-C implant in the U.S. is a 53-year-old male who suffered from a chronic painful cartilage lesion in the trochlea’s center. He received a single implant in a mini-arthrotomy approach.
“Currently we lack good treatment options for patients who experience persistent knee pain due to cartilage problems and are too young for knee replacement” said Dasa.
“The Agili-C implantation was smooth without complications. We plan to enroll more patients in the upcoming weeks and hope that this lDE trial finds that the Agili-C implant alleviates pain in these patients, allowing them to return to an active lifestyle.”
In Europe and Israel, 80 patients have already been enrolled and treated in the study. The objective of the trial is to demonstrate the superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both arthritic knees and knees without degenerative changes.
CartiHeal CEO Nir Altschuler told OTW that they expect to have a minimum of 250 participants in this pivotal IDE study and that it will take a couple of years before they have results to report.
CartiHeal, a privately held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints. In the United States the Agili-C implant is not available for sale.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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