KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/
-- 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™ implant, towards a PMA application.
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™ 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™ 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™ 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™ 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™ 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."
About CartiHeal
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™, 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.
Media Contact:
Caty Pearl | Caty@pearlcom.co.il | +972-548081020
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