CartiHeal, developer of Agili-C, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced that FDA has granted Breakthrough Device Designation for the Agili-C implant.
FDA’s Breakthrough Device Program is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients receive more timely access to these medical devices by expediting their development, assessment and review by FDA.
Cartilage, the flexible soft tissue that cushions joints – especially in the knee – cannot self-heal once damaged, because it lacks blood vessels.
The Agili-C surgical implant is a biological scaffold onto which the body’s own stem cells grow and regenerate the damaged bone and cartilage naturally. Gradually, over six to 12 months, the scaffold is replaced with a top layer of hyaline cartilage and a bottom layer of bone identical to the body’s own tissues in a normal joint.
The CartiHeal Agili-C implant is placed where the natural cartilage has degenerated and is immediately infiltrated with blood, starting a biological chain reaction. The result is regenerated bone and cartilage though migration and adhesion of stem cells. The tissue created by this little implant becomes genetically identical to the body’s own tissue. The clinical evidence of the Agili-C slowly becoming a part of the human anatomy is astounding!
“We are extremely pleased that FDA granted the Agili-C implant Breakthrough Device Designation,” said Nir Altschuler, CartiHeal’s Founder & CEO. “We look forward to working closely with FDA to expedite Agili-C’s review process, once the final IDE study results will be available, in order to provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options.”
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.