CartiHeal Performs First Agili-C(TM) Cartilage Repair Implantation Procedure in Texas

The procedure was performed by Joseph M. Berman, MD, an orthopedic
surgeon at Arlington Orthopedics Associates (AOA), Arlington, TX

Kfar Saba, Israel (ots/PRNewswire) - - CartiHeal
(http://www.cartiheal.com/), developer of Agili-C(TM), a proprietary
implant for the treatment of cartilage lesions in arthritic and
non-arthritic joints, announced today the first implantation of the
Agili-C(TM) implant, as part of Investigational Device Exemption
(IDE) clinical study by Joseph M. Berman, MD at Arlington Orthopedics
Associates (AOA), Arlington, TX.

The clinical study will involve a minimum of 250 study patients,
currently 234 patients have already been enrolled.

Arlington Orthopedics Associates is one of 15 U.S. clinical sites
participating in this randomized and controlled IDE clinical study.
The primary study objective is to demonstrate the superiority of the
Agili-C(TM) implant over the current surgical standards of care:
microfracture and debridement in the treatment of large spectrum
cartilage defects.

"I have been waiting to begin this important clinical study,
because the Agili-C(TM) implant will potentially allow me to address
a growing group of active patients with early to moderate arthritis,
which currently lacks good treatment options.

Our first patient was a 30-year-old male with two large cartilage
defects and a total surface area of 6cm. One defect was located in
the trochlea notch under the patella (knee cap) and the second defect
was located on the lateral femoral condyle. The patient was
randomized to the Agili-C(TM) treatment arm and was treated with 3
implants. We were pleased that the patient was randomized to the
Agili-C(TM) treatment arm due to the potential advantage of these
implants to reconstitute the articular cartilage and the underlying
bone, and as such, decreasing and possibly avoiding the future need
of a knee replacement," said Dr. Berman. "We are impressed with the
simplicity of the surgical technique and we continue to identify
patients to enroll in the clinical study," Dr. Berman concluded.

CartiHeal founder and CEO Nir Altschuler stated: "Dr. Berman's
first Agili-C(TM) implant case in the study provides a great example
for a patient who can potentially benefit from the technology we've
developed, assuming we can demonstrate its superiority over the
current surgical standards of care: microfracture and debridement.
With 234 patients already enrolled we are expecting to perform an
interim analysis later this year, once the remaining 16 study
patients are enrolled."

To find out if you qualify for this clinical study please visit
http://www.cartiheal.com.

About CartiHeal

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.

CartiHeal's cell-free, off-the-shelf implant is CE marked for use
in cartilage and osteochondral defects. Agili-C(TM) has been
implanted in over 400 study patients with knee, ankle, and great toe
cartilage lesions in a series of clinical trials at leading centers
in Europe and Israel - treating a broad spectrum of cartilage
lesions, from single focal lesions to multiple and large defects in
osteoarthritic patients.

In the United States, the Agili-C(TM) implant is not available for
sale - it is an investigational device limited for use in the IDE
clinical study.

Photo - https://mma.prnewswire.com/media/966026/Dr_Berman_Arington
_Orthopedics_Association.jpg

Logo - https://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg

ots Originaltext: CartiHeal (2009) Ltd.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Website: www.cartiheal.com
Email: info@cartiheal.com

Original-Content von: CartiHeal (2009) Ltd., übermittelt durch news aktuell