KFAR SABA, Israel, Aug. 27, 2019 /PRNewswire/ — CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today the first implantation of the Agili-C™ implant, as part of Investigational Device Exemption (IDE) clinical study by Joseph M. Berman, MD at Arlington Orthopedics Associates (AOA), Arlington, TX.
The clinical study will involve a minimum of 250 study patients, currently 234 patients have already been enrolled.
Arlington Orthopedics Associates is one of 15 U.S. clinical sites participating in this randomized and controlled IDE clinical study. The primary study objective is to demonstrate the superiority of the Agili-C™ implant over the current surgical standards of care: microfracture and debridement in the treatment of large spectrum cartilage defects.
“I have been waiting to begin this important clinical study, because the Agili-C™ implant will potentially allow me to address a growing group of active patients with early to moderate arthritis, which currently lacks good treatment options.
Our first patient was a 30-year-old male with two large cartilage defects and a total surface area of 6cm. One defect was located in the trochlea notch under the patella (knee cap) and the second defect was located on the lateral femoral condyle. The patient was randomized to the Agili-C™ treatment arm and was treated with 3 implants. We were pleased that the patient was randomized to the Agili-C™ treatment arm due to the potential advantage of these implants to reconstitute the articular cartilage and the underlying bone, and as such, decreasing and possibly avoiding the future need of a knee replacement,” said Dr. Berman. “We are impressed with the simplicity of the surgical technique and we continue to identify patients to enroll in the clinical study,” Dr. Berman concluded.
CartiHeal founder and CEO Nir Altschuler stated: “Dr. Berman’s first Agili-C™ implant case in the study provides a great example for a patient who can potentially benefit from the technology we’ve developed, assuming we can demonstrate its superiority over the current surgical standards of care: microfracture and debridement. With 234 patients already enrolled we are expecting to perform an interim analysis later this year, once the remaining 16 study patients are enrolled.”
To find out if you qualify for this clinical study please visit http://www.cartiheal.com.
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, 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™ has been implanted in over 400 study patients with knee, ankle, and great toe cartilage lesions in a series of clinical 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.