CartiHeal has enrolled the first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study on the East Coast.
The surgery was performed by site Principal Investigator Eric J. Strauss, an orthopedic surgeon at NYU Langone Health’s Sports Medicine Center in New York City. NYU Langone is one of 15 US sites in the new Food and Drug Administration (FDA) IDE trial and will enroll 20 patients with major knee cartilage injuries.
The first patient enrolled at NYU Langone was a 53 year-old female with a history of two failed surgeries on her left knee, who had a very symptomatic cartilage lesion, with significant bone marrow edema affecting her lateral femoral condyle.
Strauss said: “The patient was randomized to the Agili-C arm and treated with a single implant in a procedure that went smoothly and led to an immediate increase in blood flow to the affected region.”
“My colleagues and I are looking forward to building upon this first successful case and contributing to the study on treating these difficult-to-manage injuries. This investigational implant has great potential to provide an off-the shelf solution for a large spectrum of cartilage lesions.”
CartiHeal founder and CEO Nir Altschuler said: “Enrolling the first US East Coast patient is an important milestone for our study. We are honored that this important case was performed in the good hands of Dr. Eric Strauss, and look forward to his research team continuing to enroll patients.”
Altschuler also added that the IDE study, with over 100 enrolled patients, is currently ongoing in the US, EU and Israel, and aiming for an FDA premarket approval application.
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 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.
Source: Company Press Release