KFAR SABA, Israel and MILAN, Oct. 25, 2018 /PRNewswire/ -- CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions, and the Principal Investigator Professor Elizaveta Kon, MD, PhD of Humanitas Orthopedic Center of Milan, announced today the successful enrollment and surgery of the 100th patient in the Agili-C IDE pivotal study.
"I'm excited to operate on the 100th patient in this important IDE study. The patient I enrolled and operated on today is a 47-year-old female, with a 3.6cm2 osteochondral defect in the center of the trochlea" said Prof. Kon. "The patient was randomized to the Agilli-C arm and treated with a single implant. I'm very pleased that the patient was randomized to the implant group, as I have very positive experience using this implant for similar indications. If everything goes as planned, I expect fast recovery and significant pain relief. This was my 8th patient in the study and I'm planning to enroll more patients shortly", she added.
"I've been involved in CartiHeal's previous clinical trials, and operated to date on over 40 patients with the Agili-C. Based on the positive clinical outcomes from the previous studies, I have strong confidence that this implant will be a game changer in the field of cartilage repair" concluded Prof. Kon.
Nir Altschuler, CartiHeal's founder & CEO said: "Prof. Kon is a great surgeon and one of the first in the world to use our Agili-C implant. Her first patients were operated on over 4 years ago. We are pleased and impressed with her enrollment rate, and look forward to continuing our collaboration.
We'd like to thank all our Investigators and Study Coordinators for enrolling 100 patients in the first year of the study."
The IDE study that was initiated a year ago is currently ongoing in the US, EU and Israel, with the purpose of an FDA PMA application. The trial's objective 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.
For more information about the study please refer to www.cartiheal.com
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted at leading centers in Europe and Israel. 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.
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 - it is an investigational device limited for use in the IDE study only.