CartiHeal, a developer of Agili-C implant for the treatment of joint surface lesions, has enrolled first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study at The Ohio State University Wexner Medical Center.
The surgery was performed by site Investigators Dr. Christopher Kaeding and Dr. David Flanigan at The Ohio State University Wexner Medical Center in Columbus, Ohio.
The Ohio State University Wexner Medical Center is one of 30 U.S. and O.U.S sites in the new Food and Drug Administration (FDA) IDE trial aiming to show the superiority of the Agili-C implant over the current standard of care in the treatment of cartilage defects in arthritic and non-arthritic knees.
The first patient enrolled at The Ohio State University Wexner Medical Center had mild osteoarthritis and two cartilage lesions on both of the femoral condyles.
“We are very happy that our first patient in the study was randomized to the Agili-C arm. The patient was treated with two implants, one each condyle,” said Dr. Kaeding.
“Dr. Flanigan and I look forward to expanding upon our initial successful clinical procedure.”
CartiHeal founder and CEO Nir Altschuler said: “We are excited with the first enrollment at The Ohio State University Wexner Medical Center.
“The site is of great importance due to its strong professional reputation and strategic location, and we look forward to a fruitful collaboration with Dr. Kaeding and Dr. Flanigan.”
The pivotal study aims to show the superiority of the Agili-C implant over the current standard of care in the treatment of cartilage defects in arthritic and non-arthritic knees.
Agili-C is a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is a porous, biocompatible, and resorbable bi-phasic scaffold, consisting of interconnected natural inorganic calcium carbonate (aragonite).
The Agili-C 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 in 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.
The clinical study is a prospective, multi-center, open-label, randomized, and controlled trial aims to show the superiority of the Agili-C implant over the current surgical standard of care, micro-fracture or debridement, for the treatment of variety of cartilage lesions of the knee.
Source: Company Press Release