KFAR SABA, Israel, Jan. 9, 2017 /PRNewswire/ -- CartiHeal (2009) Ltd., developer of cell-free, off-the-shelf implants for use in cartilage and osteochondral defects, announced today that two clinical cases were performed in Europe with its new unicondylar implant.
CartiHeal's unicondylar implant is designed for the treatment of large cartilage lesions, typical of patients suffering from osteoarthritis. The implant is oval shaped and biodegradable (10-20mm wide, 20-40 mm long), designed to suit the joint's articular surface curvatures.
The unicondylar implant is the next generation of the cylindrical shaped Agili-C™ implant which has been used successfully in close to 250 patients throughout Europe in clinical trials in the knee, ankle and great toe.
As demonstrated in a series of preclinical studies, the new unicondylar implant regenerates hyaline articular cartilage and its underlying subchondral bone simultaneously. Due to its size and application, the unicondylar implant has the potential to become an alternative to metal prosthesis used in partial and full knee replacements.
The first two clinical cases using CartiHeal's unicondylar implant were performed by Dr. Matej Drobnic at the University Medical Center, Ljubljana, Slovenia. A 35 year old female who suffered from mild osteoarthritis of the knee, with a 4cm² trochlear lesion, received a single unicondylar implant. The second case was performed on a 45 year old male who suffered from moderate osteoarthritis of the knee, 15 years post ACL reconstruction. A large unicondylar implant was used to resurface a 5cm² lesion in the load bearing medial femoral condyle, while a cylindrical Agili-C™ implant was used to treat a 3cm² lesion in the trochlea. A malalignment correction, with a high tibial osteotomy and meniscus surgery were performed concomitantly to the implantations.
"Both patients were candidates for partial knee replacement, however given their young age and level of activity we preferred to use this novel implant", said Dr. Drobnic. "The implantations were smooth and without technical difficulties. Further to my experience with this technology over the last five years in a series of clinical trials, I believe that this implant has the potential to revolutionize the paradigm of joint surgeries and provide a solution for a true unmet need in young and active patients with large cartilage legions and moderate osteoarthritis".
"The cases conducted today were the result of several years of intensive R&D and preclinical effort" said Nir Altschuler, CartiHeal's founder and CEO. "Our goal is to provide orthopedic surgeons with a variety of implants that can treat different joints and indications. We believe our new unicondylar implant will provide a viable solution for patients with osteoarthritis who suffer from severe pain, but are still active and wish to avoid joint replacement."
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 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 pain reduction, as well as reduction in related symptoms through a simple, single-step implantation procedure.
The Agili-CTM implant (cylindrical) is CE marked, approved for use in the EU. In the United States, the Agili-CTM is an investigational device that is limited to use in the IDE study. It is not available for sale.
The Agili-CTM unicondylar implant is CE marked, currently used in a European clinical studies. The implant is not available for sale.
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SOURCE CartiHeal (2009) Ltd.