CartiHeal, Inc., a privately held medical device company headquartered in Israel, has announced that Seth L. Sherman, M.D., a sports medicine orthopedic surgeon at Missouri Orthopaedic Institute of the University of MIssouri, recently was one of the first American surgeons to enroll patients in a clinical trial which will hopefully lead to Federal Drug Administration approval of CartiHeal’s new knee cartilage repair implant.
Four patients were enrolled in the clinical trial and underwent the Agili-C cartilage repair implantation procedure by Sherman at Missouri Orthopaedic Institute.
The Agili-C implant is designed to help patients with knee cartilage defects to regenerate their own healthy cartilage. Sherman is one of 15 primary investigators in the United States conducting the FDA Investigational Device Exemption (IDE) study which will demonstrate the superiority of the Agili-C implant over current standard of care, microfracture and debridement.
“We are thrilled to be on the leading edge of orthopaedic sports medicine and joint preservation,” Sherman said.
“In the US, there are limited options for off the shelf cartilage repair technologies that can be used by sports medicine surgeons performed during a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, without burning future bridges, and strong previous basic science and clinical track record.”
Unlike other implants, this one is medically-indicated for a variety of cartilage defects and types of patients. Even patients with mild to moderate osteoarthritis can benefit from it so there are more patients that are good candidates for this procedure.
Patients enrolled in the clinical trial are randomly assigned to either a new implant or one of the traditional surgical options. Sherman has enrolled four patients so far and has more procedures planned in the coming weeks.
“We wish to congratulate Dr. Sherman for enrolling these four initial patients. The enrollment rate is exceeding our expectations, with over 130 patients enrolled in both United States and Outside United States centers since the study’s initiation in October 2017,” said Nir Altschuler, founder and CEO of CartiHeal.
“We look forward to a fruitful collaboration with the Missouri Orthopaedic Institute, and to benefit patients suffering from a variety of cartilage lesions, who currently have limited options.”
