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Last updated on April 16, 2014 at 11:16 EDT

Regentis Biomaterials Receives European CE Mark Approval for GelrinC

March 18, 2013

Biodegradable implant provides new option to help grow quality cartilage in damaged knee joints

OR AKIVA, Israel and PRINCETON, New Jersey, March 18, 2013 /PRNewswire/ –

Regentis Biomaterials Ltd. [http://www.regentis.co.il ], a privately held company
focused on developing proprietary hydrogels for tissue regeneration, announced today it
has received European CE Mark approval for its GelrinC(TM) biodegradable implant.

GelrinC is the first synthetic implant to be CE-approved that provides a customized
solution by completely filling cartilage lesions with acellular material. GelrinC allows
high quality cartilage to regenerate in the knee in the exact shape of the defect. It is
an off-the-shelf product that is cost-effective and allows patients’ knees to be pain-free
and function normally.

“This approval represents a major milestone in the development of cartilage repair
technologies since it enhances growth of high-quality cartilage that fits tightly with the
surrounding cartilage and underlying bone,” said Regentis Biomaterials president and CEO
Alastair Clemow, Ph.D. “With CE Mark approval, we look forward to making GelrinC available
to European patients to help them return to an active lifestyle.”

GelrinC is suitable for patients with traumatic knee injuries. It is inserted as a
liquid to fill any shape of cartilage defect and it is then converted into a solid through
exposure to ultra-violet light. GelrinC’s matrix of synthetic polyethylene glycol
diacrylate and denatured fibrinogen creates an environment conducive to cartilage tissue
regeneration. After GelrinC is implanted, it starts to bio-degrade as it is replaced with
new hyaline-like cartilage.

Regentis conducted a clinical trial treating 23 patients with damaged articular
cartilage. The results were extremely positive with patients’ knees effectively returning
to normal, pain-free function. Regentis will continue to develop additional clinical data
and initiate the marketing of GelrinC in select European countries. The CE Mark also opens
the door to other international marketing efforts.

“GelrinC provides patients a customized solution with minimized costs because it is
available off-the-shelf and applied in a single procedure,” said Clemow. “This makes the
implant an ideal treatment option that surgeons can now offer patients with traumatic knee
cartilage damage.”

GelrinC is based on a hydrogel platform that serves as the foundation for future
clinical applications including those for nerve and bone regeneration as well as cardiac
repair. GelrinC is an investigational device and not available for sale in the U.S. and
Israel. The company is conducting a clinical trial in Europe with its investigational
version of GelrinC.

About Regentis Biomaterials

With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a
privately held company focused on developing and commercializing proprietary hydrogels for
tissue regeneration. The company’s core technology is a biodegradable hydrogel called
Gelrin(TM). It is based on polyethylene glycol diacrylate and denatured fibrinogen
originally developed at the Technion – Israel Institute of Technology by Dr. Dror
Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a
synthetic material with the bio-functionality of a natural substance for a range of
clinical applications. The company’s flagship product, GelrinC(TM), designed for the
treatment of articular cartilage lesions. For more information, please visit

http://www.regentis.co.il.

        For more information, please contact
        Alastair Clemow, Ph.D. President & CEO
        Tel: +972-4-6265502
        aclemow@regentis.co.il

        For media inquiries, please contact:
        Josh Turner
        In North America: +917-231-0550
        Rest of the world: +972-54-949-6526
        josh@joshturnerpr.com

SOURCE Regentis Biomaterials Ltd.


Source: PR Newswire