August 21, 2014 1:18 AM ET

Biotechnology

Company Overview of Regentis Biomaterials Ltd.

Company Overview

Regentis Biomaterials Ltd., a tissue repair company, develops and commercializes biodegradable hydrogels for the repair of damaged cartilage and bone. Its products include GelrinC, a biodegradable hydrogel for articular cartilage regeneration; GelrinB, a biodegradable hydrogel for bone regeneration; and GelrinA, a void filling matrix for aesthetic indications. The company was founded in 2004 and is based in Or-Akiva, Israel.

2 Ha’ilan Street

Northern Industrial Zone

Or-Akiva,  30600

Israel

Founded in 2004

Phone:

972 4 626 5502

Fax:

972 4 626 5504

Key Executives for Regentis Biomaterials Ltd.

Chief Executive Officer and President
Age: 62
Co-Founder
Vice President of Business Development and General Manager of Israel Office
Vice President of Research & Development
Clinical Advisor
Compensation as of Fiscal Year 2014.

Regentis Biomaterials Ltd. Key Developments

Regentis Biomaterials Announces Clinical Data of Gelrinc Implant for Treating Articular Cartilage in Injured Knees

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

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.

Regentis Biomaterials Receives European CE Mark Approval for Gelrinc

Regentis Biomaterials Ltd. announced it has received European CE Mark approval for its GelrinC 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. 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. 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.

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