Israeli startup CartiHeal announced successful enrollment of the first two U.S. patients in the Agili-C™ Investigational Device Exemption (IDE) pivotal study.
The IDE trial’s objective is to demonstrate superiority of the Agili-C implant vs. microfracture and debridement for the treatment of cartilage or osteochondral defects, in both arthritic knees and those without degenerative changes. The study received FDA approval at the end of 2016. To date, 80 patients in Europe and Israel have been enrolled and treated in the study, which will include a minimum 250 patients in U.S. and ex-U.S. centers in support of a premarket approval submission. Seventeen patients were enrolled and treated during the first week of the study in three leading European centers.
Agili-C is a porous, biocompatible and resorbable bi-phasic scaffold, consisting of interconnected natural inorganic calcium carbonate (aragonite). The implant is designed so that cartilage and bone cells adhere to it while at the same time gradually degrade the calcium from the scaffold.
“The need for an implant that leads to the regrowth of damaged cartilage is a real urgency in [orthopaedics],” Dr. Adi Friedman told The Times of Israel. Dr. Friedman, who implanted the Agili-C in the first Israeli patient earlier this month, is the Director of the Center for Arthroscopic Surgery and Sports Injuries of the Department of Orthopedic Surgery at Hadassah Medical Center in Jerusalem.
CartiHeal employs 30 people and has raised ~US $21MM to date from investors that include Acclemed, Access Medical Ventures, aMoon, Bioventus, Elron Electronic Industries, Johnson & Johnson and Peregrine Ventures.
“The whole market is looking at cartilage replacement,” Anthony P. Bihl III, Bioventus’ CEO, told us at AAOS earlier this year, in comments originally published in ORTHOKNOW®. “There are a number of technologies out there in clinical studies. …We put money into [CartiHeal] because we think [Agili-C] is good enough that we want to be part of it, but not good enough that we want to own the thing—and they aren’t interested, either. The point I want to make is it’s a developing market, and we’re starting to see enough products that have some data that shows that biologics are going to grow. It’s a very important market. What we love about it is we’re working with solutions that activate the body’s natural healing.”
* Image courtesy of CartiHeal