OR AKIVA, Israel and PRINCETON, New Jersey, August 28, 2017 /PRNewswire/ --
Regentis Biomaterials Ltd., a privately held company developing proprietary hydrogels for tissue regeneration, announced today it has received European CE mark approval for its GelrinC® biodegradable implant. The approval covers GelrinC manufactured using denatured human fibrinogen and expands upon the existing CE mark for a version containing denatured bovine-sourced fibrinogen. This latest approval enables Regentis to begin accessing new global markets, and helping more patients suffering from damaged articular knee cartilage.
"Since a CE mark is recognized internationally, this key approval opens the door to making the product available in many other territories," said Regentis Biomaterial CEO Alastair Clemow, Ph.D.
GelrinC is designed to quickly and easily treat articular knee cartilage defects, both chondral and osteochondral. With a minimally invasive procedure, surgeons apply GelrinC into lesions as a liquid allowing it to fill any size and shape of defect. After a short exposure to ultra-violet light, GelrinC is converted into a solid implant which gradually degrades in a controlled manner. Over time, the implant is replaced with newly formed cartilage tissue that is similar to native cartilage, and fits within the surrounding cartilage and underlying bone.
A long-term European clinical study of GelrinC, focusing on patients with damaged articular knee cartilage, demonstrated sustained relief of symptoms with most patients regaining pain-free knees. MRI imaging further revealed that the regenerated cartilage had properties that were comparable to natural cartilage. Regentis is currently conducting an FDA-approved Phase III pivotal multi-site clinical trial on GelrinC in the U.S. and Europe to support a PMA application, a key step to having the product approved for patients in the U.S.
"The data from our European clinical study indicates that GelrinC provides surgeons with an effective one-step treatment. GelrinC is an off-the-shelf product that can be used at any time during surgery when a lesion is identified without the need for pre-planning or additional surgeries," said Dr. Clemow. "This makes GelrinC an attractive treatment option that is as simple to perform as microfracture with superior clinical outcomes. With a potential yearly market of more than 150,000 procedures in the U.S. alone, the opportunities for GelrinC as the primary treatment for articular knee cartilage repair are very exciting."
GelrinC is an investigational device and not available for sale in the U.S.
About Regentis Biomaterials
With offices in Israel and the U.S., Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company's core technology platform is based on a series of hydrogels utilizing both polyethylene glycol diacrylate and denatured fibrinogen that combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance. This technology serves as the foundation for future clinical indications in osteoarthritis. The company's flagship product, GelrinC® is 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
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SOURCE Regentis Biomaterials Ltd.