KFAR SABA, Israel, December 20, 2016 /PRNewswire/ --
PMA Pivotal Study will start during 2017
CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of the Investigational Device Exemption (IDE) application submitted by CartiHeal for their Agili-C(TM) implant, towards a PMA application.
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The 2 year-long pivotal study will involve a minimum of 250 patients in US and OUS centers. The study is aimed to show superiority of the Agili-C(TM) implant over surgical standard of care, i.e. microfracture and debridement, in the treatment of cartilage/osteochondral defects in both osteoarthritic knees and in knees without degenerative changes, making it the first approved study of such broad indications using a single implant.
The study is designed as a prospective, multicenter, open-label, randomized and controlled trial, involving up to 3 lesions in the same joint and with a total treatable area of 1-7cm2.
Agili-C(TM) was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 220 patients with cartilage lesions in the knee, ankle and great toe. In these trials the implant was used for the treatment of a wide spectrum of cartilage lesions, according to its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.
Results of these prior investigations demonstrated the potential for cartilage regeneration and remodeling of the underlying subchondral bone, along with pain and symptom relief.
"Pivotal studies performed to date were always focused on small, focal and isolated cartilage lesions in a narrowly defined patient group, which does not represent most of the 'real-life' cases," explains Dr. Ken Zaslav, President of the International Cartilage Repair Society (ICRS) and a member of CartiHeal's Clinical Advisory Board. "Based on the robust clinical data of the Agili-C(TM) implant, FDA has allowed for the first time, treatment indications ranging from single focal defects to multiple defects in osteoarthritis of the knee, which is what us surgeons see on a daily basis. Moreover, this exciting study will compare two control modes in a single arm: microfracture for the treatment of focal lesions and debridement for patients with osteoarthritis."
"Over the last few years we've conducted a series of clinical studies in leading centers to learn which kind of patients can benefit from the Agili-C(TM) implant," says Nir Altschuler, CartiHeal's founder and CEO. "Together with our Clinical Advisory Board we designed a study that targets a large patient population who can potentially benefit from this implant. We are very pleased that FDA approved our study design, and believe that the Agili-C(TM) implant will prove to be an ideal treatment for a variety of cartilage lesions in patients who wish to return to a painless and active lifestyle, and currently don't have good alternatives."
CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
Backed by extensive pre-clinical and clinical data, its flagship product Agili-C(TM), an aragonite-based biodegradable scaffold, has been shown to promote restoration of hyaline cartilage and remodeling of its underlying subchondral bone through a natural process, without the use of cells or growth factors.
Clinical results in the knee, ankle and big toe demonstrated the potential of significant improvement in pain reduction, as well as reduction in related symptoms - through a simple, single-step implantation procedure.
In the United States, the Agili-C is an investigational device that is limited to use in the IDE study. It is not available for sale.
CartiHeal (2009) Ltd.