JNJ Leads $15 Million Funding for Innovative Cartilage Technology

Johnson & Johnson Innovation (JJDC investors) joins a blue chip list of venture investors including Elron, Accelmed, Access Medical Ventures, and Peregrine Ventures to fund an innovative cartilage repair technology called Agili-C and a promising young Israeli company named CartiHeal, Ltd.

Agili-C, the technology that has attracted these top venture investors, is a calcium carbonite and HA (hyaluronic acid) implant that has been shown in several post-marketing studies (phase IV studies) to provide significant improvement in knee pain level, as well as reduction in related symptoms. Investigators who reviewed MRIs and histological findings of joints with an Agili-C implant found regeneration of hyaline cartilage and its underlying subchondral bone.

The key to Agili-C is a novel (to orthopedics) type of calcium carbonate named Aragonite. Aragonite is, one of the two common, naturally occurring, crystal forms of calcium carbonate, CaCO₃ (the other form being the mineral calcite), which is formed by biological and physical processes, including precipitation from marine and freshwater environments.

As the clinical evidence from Agili-C is showing, when implanted in a joint (and physicians have implanted Agili-C in about 200 patients to date) this material appears to be both osteoconductive and osteotransductive at the bone phase and chondrogenic at the cartilage phase. When CartiHeal’s scientists look at why this is occurring, they point to Aragonite’s macro and micro porosity and interconnected porosity as well as its unique chemical composition.

CartiHeal, Ltd., which was founded in 2009 by CEO Nir Altschuler after he developed a way to transform coral into a cartilage regenerative scaffold, is a privately held medical device company based in Israel. The $15 million investment will be used to, among other purposes, fund European expansion and manufacturing of Agili-C and to advance clinical trials in other therapeutic areas.

Agili-C is, says the company, the world’s first off-the-shelf, cell-free cartilage and bone regeneration implant.

Lead investor, JJDC, is a venture capital subsidiary of Johnson & Johnson, Inc. that funds promising new market opportunities in health care and technology. “This round of funding is a testament to our investor’s commitment and satisfaction with CartiHeal’s progress, ” says Uri Geiger, managing partner of Accelmed and a CartiHeal board member.

So far, Agili-C has been used to treat patients with painful, arthritically damaged knees. Recently a few physicians have been testing Agili-C in other diseased joints. In the future the company hopes to segue into treating the ankles and big toes and other cases of moderate osteoarthritis.

When treating patients with Agili-C, physicians implant the material using a mini-arthrotomy approach. Once the physician determines the size of the cartilage defect they then drill a hole in the affected area and insert Agili-C in a press fit manner slightly below the articular surface. Because of drilling, blood from the subchondral bone wicks into the Agili-C’s interconnected pores and lays the foundation for both bone and cartilage repair if not also regeneration.

The Agili-C implant is CE Mark certified as a “Bi-phasic, porous, resorbable, tissue regeneration scaffold, for the treatment of articular cartilage and/or osteochondral defects.”

“Because the Agili-C implant is suitable for a wide range of pathologies, from traumatic injury to moderate osteoarthritis, the device meets a vast, unmet need, ” says Altschuler. “This investment positions CartiHeal as a significant player for treating early-onset osteoarthritis that hasn’t responded to conservative treatment but for which joint replacement isn’t yet necessary.”

The Agili-C implant was named by Israel 21c newsletter as “one of the top 10 most extraordinary medical devices that promises to revolutionize global healthcare.” In June 2009 it was also designated one of the Top 10 medical devices by Medtech Insight, which called Agili-C technology the “holy grail” of orthopedic advances.

For the past three years the device has been successfully implanted in 200 patients in leading orthopedic facilities in Italy, Slovenia, Poland, Belgium, Austria, Romania, Serbia, Switzerland and the Netherlands. CartiHeal is now initiating discussions with the FDA in the U.S. with the aim to begin clinical studies in 2017.