CartiHeal Ltd., developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today announced its first commercial implantation of Agili-C in the US by Dr. Ken Zaslav, a specialist in Orthopedic Surgery and Sports Medicine at Northwell Health in New York City, NY.
The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration. Agili-C received FDA breakthrough designation status in 2020 and demonstrated clinical superiority to the surgical standard of care (SSOC)—microfracture and debridement—in one of the largest cartilage clinical trials on record with the broadest inclusion criteria, which was meant to mimic real-life patients. This resulted in the Agili-C implant receiving FDA approval with an indication for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Dr. Zaslav commented, "Agili-C is a technology I and others in the surgical community have been watching and waiting on for over 10 years. It is a novel implant supported by 4-years of data and counting from the multinational, randomized and controlled IDE clinical trial. Agili-C offers a cost efficient, off-the-shelf implant to fill an unmet need in my clinical practice."
"We are thrilled to share the Agili-C technology with the surgical community with a goal for it to reach every surgical facility in the US and beyond," said Nir Altschuler, CartiHeal's Founder and CEO. "This is a milestone achievement for everyone at CartiHeal and we would like to congratulate Dr. Zaslav on successfully performing our first commercial case in the US."
Agili-C is available nationwide.
About CartiHeal
CartiHeal is an Israel and New Jersey based, privately held medical device company focused on the design, development, and commercialization of proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
Prescribing information
The Agili-C(TM) scaffold is indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
For more information
www.cartiheal.com
Media contact:
Lizet Shilo
info@cartiheal.com
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