After repeated attempts to fix the worn-down cartilage in her knee failed to bring relief, a 30-year old woman in Jerusalem earlier this month received an implant made of aragonite, a form of calcium carbonite, which, if all goes well, will help regenerate her cartilage and bone over time.
The implant was developed by the Israeli startup CartiHeal Ltd., which is conducting a global clinical trial of its technology and hoping to receive approval from the US Food and Drug Administration. The goal is to commercialize a product that could bring relief to millions of sufferers of cartilage knee pain within a few years.
“Millions of patients are looking for a solution to the degeneration of knee cartilage,” said Nir Altschuler, the CEO and founder of CartiHeal, which he set up in 2009 in collaboration with Ben-Gurion University of the Negev. “We hope we can provide a breakthrough with our technology.”
“Cartilage has very limited ability to be repaired,” he said. “Finding a solution for cartilage regeneration is one of the holy grails of medicine.”
CartiHeal believes it has found the solution for people who have cartilage defects with or without mild to moderate knee osteoarthritis, a deterioration of cartilage and the underlying bone.
“The idea is to capture patients who are still active and to try to treat them before they reach the need for a knee replacement,” he said in a phone interview from New Jersey, where he recently moved with his family to supervise the multi-center clinical trial that is taking place in Israel, the United States and Europe.
Knee pain is a common complaint that affects people of all ages. It can result from an injury, such as a torn ligament or cartilage, or from medical conditions that can also can cause knee pain. Osteoarthritis is one of the most common degenerative joint diseases, affecting more than 25 percent of people over 18, according to research published in nature.com.
Treatments for knee pain include physical therapy and knee braces, but surgical procedures may also be required.
For CartiHeal’s implant, surgeons drill out the affected area of both cartilage and bone in a minimally invasive procedure, making sure to get to the bone marrow and the stem cells within the treated area. They then insert a cylindrical scaffold that fits into the opening like a plug, “just like an screw-anchor in a wall,” he explained.
The implant, called Agili-C, is made of aragonite — a mineral found in nature — modified by the startup’s patented technology so that it can interact with the implantation site. Cartilage and bone cells adhere to the implant, Altschuler said, while at the same time gradually degrading the calcium from the scaffold. Eventually the implant is almost fully degraded as bone and cartilage regrow.
The startup is looking to develop the implants, which are suitable for all patients and do not require biopsies or special matching, to make them an off-the-shelf product for surgeons.
“This is a very important study for us,” as it will hopefully pave the way for FDA approval, he said, explaining why he is personally monitoring the study in the US. The product has already received CE certification in Europe, but the firm is waiting on commercialization until the end of enrollment of patients in the US, said Altschuler. Some 400 patients in centers in Europe have already received the implants, he added.
To be eligible for the clinical trial, among other factors patients need to have a painful cartilage defect, with or without mild to moderate osteoarthritis, and a still functional meniscus, he explained.
To date, about 80 patients in leading hospitals abroad have been recruited for the trial, out of 250 planned in total, the company said.
The startup, which operates from Kfar Saba, Israel and employs 30 people, has raised some $60 million to date, from investors including Elron Electronic Industries, the Accelmed investment firm, Access Medical Ventures, Peregrine Ventures, and the aMoon Fund of Marius Nacht and Dr. Yair Schindel. Other strategic investors include Johnson & Johnson, through its JJDC investment arm and Bioventus.
The implant in Israel was performed by Dr. Adi Friedman, director of the Center for Arthroscopic Surgery and Sports Injuries, of the Department of Orthopedic Surgery at Hadassah Medical Center in Jerusalem.
“The need for an implant that leads to the re-growth of damaged cartilage is a real urgency in the orthopedic field; we hope the experiment will succeed, and that the implant will be the breakthrough that we have been waiting for, for many years,” Friedman said in a statement. “The transplant went smoothly, and I am hopeful that the patient will soon return to a fully functional and pain-free life. We intend to recruit more patients for the trial. “