Regentis Biomaterials Ltd., a tissue repair company, develops and commercializes biodegradable hydrogels for the repair of damaged cartilage tissue. It offers GelrinC, a biodegradable hydrogel platform for the repair of cartilage defects that include micro fracture, mosaicplasty, osteochondral autologous (or autograft) transplantation system, and autologous chondrocyte implantation, as well as for the treatment of painful injuries to articular knee cartilage; and Gelrin, a hydrogel matrix of polyethylene glycol diacrylate (PEG-DA) and denatured fibrinogen that combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance. The company was fou...
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Regentis Biomaterials Announces Clinical Data of Gelrinc Implant for Treating Articular Cartilage in Injured Knees
Sep 16 13
Regentis Biomaterials announced a new clinical data demonstrating the efficacy and safety of its GelrinC implant for treating articular cartilage in injured knees. As presented at the International Cartilage Repair Society World Congress in Izmir, Turkey, the clinical results demonstrated sustained knee function improvement over 24 months after implantation and significant pain reduction. In addition, the clinical safety data showed that adverse effects were limited and comparable to those reported in similar studies with no serious adverse events related to the implant. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. In the knee, this cartilage can be damaged by a traumatic sports accident or a bad fall. A painful injury for patients, repairing articular cartilage is a challenge for doctors to treat since the tissue has no capacity to heal itself. GelrinC is a biodegradable hydrogel implant designed to treat cartilage defects in the knee. It is administered as a liquid to fill any shape of cartilage defect and it is then converted into a solid after 90 seconds of exposure to ultra-violet light. The GelrinC implant naturally degrades within 6-12 months and is replaced with functional and durable cartilage. After two years of study, patients had a substantial improvement of the Knee injury and Osteoarthritis Outcome Score (KOOS), excluding the sports subscale, of 23.6 points at 18 months, representing a 43% improvement, and 32.9 points at 24 months, representing a 60% improvement (52.6 vs. 84.1). KOOS is a patient-reported outcome measurement instrument developed to assess a patient's opinion about their knee and associated problems. Scores from the international knee documentation committee (IKDC), another measure of patient progress, were even more impressive. The subjective questionnaire showed an improvement of 86% at 18 months and 94% at 24 months (40.4 vs. 78.4). The clinical results came from a single-arm, multi-center study that involved 23 patients in Europe and Israel. An additional 30 patients are currently enrolled at 12 new sites in Germany, Belgium, Poland, the Netherlands and Israel. CE mark-approved, GelrinC is an investigational device and is not available for sale in the U.S. and Israel.
Regentis Biomaterials Ltd. Expands Clinical Study of GelrinC for Cartilage Repair
Apr 10 13
Regentis Biomaterials Ltd. announced that it has expanded the clinical study of its GelrinC(TM) 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. 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.