Regentis Biomaterials Expands Clinical Study of GelrinC for Cartilage Repair Study of cartilage implant expands to 12 sites; number of patients treated more than doubles; Expanded study's first patient treated at Tel Aviv Sourasky Medical Center
OR AKIVA, Israel and PRINCETON, New Jersey, April 10, 2013 /PRNewswire/ --
Regentis Biomaterials Ltd., a privately held company focused on developing proprietary hydrogels for tissue regeneration, announced today that it has expanded the clinical study of its GelrinC™ implant to 12 new sites in Germany, Belgium, Poland, the Netherlands and Israel. The study will enroll an additional 30 new patients, which will more than double the size of the clinical study, and bring the total number of treated patients to 53. The expanded study's first additional patient was treated at the Tel Aviv Sourasky Medical Center this week.
The biodegradable GelrinC implant helps grow hyaline-like cartilage in damaged knees by completely filling cartilage lesions with acellular material. The regenerated cartilage takes the exact form of the defect and allowing a patient's knees to function normally and pain-free. GelrinC is an off-the-shelf product that is cost-effective and is suitable for patients with traumatic knee injuries.
"We have seen huge benefits for patients using GelrinC and this study's expansion is indicative of the results we have obtained to date," said Regentis Biomaterials President and CEO Alastair Clemow, Ph.D. "With this expanded study, we will gain even more evidence to demonstrate GelrinC's effectiveness, a step to making it widely available so that patients can return to an active lifestyle."
The insertion of GelrinC creates an environment conducive to cartilage tissue regeneration. It is inserted as a liquid to fill any form of cartilage defect and it is then converted into a solid through exposure to ultra-violet light. After it is implanted, the acellular material starts to bio-degrade as it is replaced with new, high-quality cartilage.
"With the expansion of the study, we look forward to fully realizing the potential of this novel and promising technology," said study investigator Dr. Ron Arbel who treated the expanded study's first patient at the Tel Aviv Sourasky Medical Center. "The current results from the clinical study indicate that GelrinC is an effective treatment that surgeons can easily apply to patients suffering from traumatic cartilage damage. We look forward to gaining extensive data and to fully realize this treatment's potential to restore patients' knees."
GelrinC is an investigational device and not available for sale in the U.S. and Israel. It recently received CE mark approval in Europe.
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™. 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™, designed for the treatment of articular cartilage lesions. For more information, please visit http://www.regentis.co.il.
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Alastair Clemow, Ph.D. President & CEO
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SOURCE Regentis Biomaterials Ltd.