KFAR SABA, Israel, June 12, 2019 /PRNewswire/ -- CartiHeal, developer of the Agili-C™ implant for treating cartilage and osteochondral defects in traumatic and osteoarthritic joints, successfully enrolled the 200th patient in the Agili-C™ IDE pivotal clinical study. Surgery was performed by Scott Hacker, MD, at Grossmont Hospital, San Diego, CA.
The 200th study patient was a 59 year old male with moderate osteoarthritis and two large lesions on the trochlea and the medial femoral condyle. The patient was randomized to the Agili-C™ arm of the study and treated with 3 implants.
According to Dr. Ken Zaslav, CartiHeal's Chief Medical Officer and past President of the International Cartilage Repair Society (ICRS), "the idea of the study design was to treat patients that we, as orthopedic surgeons, see on a daily basis in our clinics and operating rooms. The most recent case performed by Dr. Hacker provides an excellent example of that. The goal of the study is to show that the Agili-C™ implant provides superior treatment over the current surgical standard of care, microfracture and debridement, for wide range of cartilage lesions."
"We are very pleased from the fact that the top surgeons in the world have elected to participate in our clinical study and that the enrollment rate is exceeding our expectations. Within a year and a half from the study start 200 patients have been enrolled. Accordingly, to current projections, we estimate that enrollment will be completed in the upcoming months," said Nir Altschuler, CartiHeal's founder and CEO.
A video testimonial of Prof. Elizaveta Kon and Dr. Francesca de Caro, from Italy, who've already enrolled 26 patients into the IDE pivotal clinical study, provide additional insight to the Agili-C™ implant.
CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ was implanted in over 400 patients with knee, ankle, and great toe cartilage lesions in a series of trials at leading centers in Europe and Israel – treating a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in osteoarthritic patients.
In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE clinical study.