Tele: 561.316.3330
Breaking Medical Device News

Saturday, October 16, 2021
HomeCartiHealCartiHeal Performs First Agili-C™ Implant Case on the East Coast

CartiHeal Performs First Agili-C™ Implant Case on the East Coast

CartiHeal, developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, announced today the successful enrollment of the first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study on the East Coast.

The surgery was performed by site Principal Investigator Eric J. Strauss, MD, an orthopedic surgeon at NYU Langone Health’s Sports Medicine Center in New York City. NYU Langone is one of 15 U.S. sites in the new Food and Drug Administration (FDA) IDE trial and will enroll 20 patients with major knee cartilage injuries.

The first patient enrolled at NYU Langone was a 53 year-old female with a history of two failed surgeries on her left knee, who had a very symptomatic cartilage lesion, with significant bone marrow edema affecting her lateral femoral condyle. “The patient was randomized to the Agili-C arm and treated with a single implant in a procedure that went smoothly and led to an immediate increase in blood flow to the affected region,” according to Dr. Strauss.

“My colleagues and I are looking forward to building upon this first successful case and contributing to the study on treating these difficult-to-manage injuries. This investigational implant has great potential to provide an off-the shelf solution for a large spectrum of cartilage lesions.”

Nir Altschuler, CartiHeal’s founder & CEO said: “Enrolling the first US East Coast patient is an important milestone for our study. We are honored that this important case was performed in the good hands of Dr. Eric Strauss, and look forward to his research team continuing to enroll patients.”  Altschuler also added that the IDE study, with over 100 enrolled patients, is currently ongoing in the US, EU and Israel, and aiming for an FDA premarket approval application.

CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted in leading centers in Europe and Israel. In these trials, the 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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy