CartiHeal Performs First Agili-C(TM) Cartilage Repair Implantation Procedures at Hospital for Special Surgery (HSS), New York, NY

Two patients were enrolled and operated on by sports medicine
surgeon Andreas Gomoll, MD

Kfar Saba, Israel (ots/PRNewswire) - CartiHeal, developer of
Agili-C(TM), a proprietary implant for the treatment of cartilage
lesions in arthritic and non-arthritic joints, announced today the
successful enrollment and operation of the first two patients in the
Agili-C(TM) Investigational Device Exemption (IDE) pivotal study at
Hospital for Special Surgery (HSS), New York, NY. The surgeries were
performed by site Principal Investigator Prof. Andreas Gomoll, MD, a
sports medicine orthopedic surgeon.

The multi-site clinical study will involve a minimum of 250
patients, which 228 patients have already been enrolled.

HSS is one of 15 U.S. clinical sites participating in this
randomized and controlled Food and Drug Administration (FDA) IDE
clinical study. The primary study objective is to show superiority of
the Agili-C(TM) cartilage regeneration implant over the current
standards of care: microfracture and debridement.

"I was very pleased that my first two patients in the clinical
study were both randomized to the Agili-C(TM) arm. The first patient
had mild osteoarthritis and osteochondral defect on the load bearing
area of the medial femoral condyle and was treated with a single
Agili-C(TM) implant. The second patient, also with mild
osteoarthritis, had two symptomatic lesions located at the center of
the trochlea and on the load bearing area of the medial femoral
condyle and was treated with two Agili-C implants," said Prof.
Gomoll.

"The two procedures went smoothly and I look forward to enrolling
more patients into this important clinical study in the upcoming
weeks," concluded Prof. Gomoll.

CartiHeal's founder and CEO Nir Altschuler states: "We are excited
that Prof. Gomoll has joined our clinical study as a principal
investigator. Prof. Gomoll is one of the most prestigious cartilage
surgeons and we expect that his impact on the clinical study will be
very significant."

"With top institutions, such as HSS involved in the clinical
study, and with 228 patients already enrolled out of 250 patients
planned, we hope to meet the clinical study's endpoint and provide a
viable treatment option to millions of patients in need."

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

About CartiHeal

CartiHeal, a privately-held medical device company headquartered
in Kfar Saba, Israel and New Jersey, USA, 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 patients with cartilage lesions in the knee,
ankle and great toe in a series of clinical studies conducted in
leading centers in Europe and Israel. In these clinical studies, the
Agili-C(TM) implant was used to treat a broad spectrum of cartilage
lesions, from single focal lesions to multiple and large defects in
patients suffering from osteoarthritis.

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

Photo - https://mma.prnewswire.com/media/956906/Andreas_Gomoll.jpg

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

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

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

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