Unique Israeli Company CartiHeal Gets CE Mark (Biloine Young @ OTW)
An Israeli company has received CE Mark certification for the EU for a cartilage defect repair product, based solely on a preclinical trial. The company is CartiHeal Ltd and the product is Agili-C. Nir Altschuler, a biomedical engineer who founded the company in 2009, said, "It is very unusual to obtain CE Mark without clinical trials, but the preclinical trial results were good enough." He established the company based on a concept discovered at Ben Gurion University of the Negev. The product is also certified in Israel.
Agili-C is produced in two parts. One is made of aragonite, and the other is made of aragonite and hyaluronic acid. Both are biocompatible and biodegradable. The product does not include living tissue, in contrast to other products under development. "We found that these materials attract stem cells from the bone marrow, so that only cells in aragonite area turn into bone, and cells in the area of the aragonite and hyaluronic acid turn into cartilage," says Altschuler.
The Agili-C, an articular cartilage and osteochondral defect repair product, is implanted through minimally invasive sur...
