Company Overview of Regentis Biomaterials Ltd.
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...
12 Ha’ilan Street
Northern Industrial Zone
Founded in 2004
Key Executives for Regentis Biomaterials Ltd.
Chief Executive Officer and President
Co-Founder and Chief Scientific Officer
Executive Vice President and General Manager of Israel Office
Vice President of Research & Development
Vice President of Clinical Affairs
Compensation as of Fiscal Year 2016.
Regentis Biomaterials Ltd. Key Developments
Regentis Biomaterials Receives IDE Approval for Pivotal GelrinC Clinical Trial
Sep 26 16
Regentis Biomaterials announced that it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical study of GelrinC, a novel treatment for focal cartilage defects in the knee. This clinical study will be used to support a Premarket Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S. The cartilage repair market is the unmet need in orthopedic sports medicine, and represents an estimated market opportunity of more than $1 billion. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Cartilage has limited ability to repair itself, which means that surgical intervention is often required. Focal defects typically occur as a result of trauma and are extremely painful to the patient. Microfracture, the standard of care procedure, provides only short-term relief to patients and often requires additional surgical intervention. The GelrinC procedure is easy and quick for surgeons to perform and can be carried out using a minimally invasive approach. It is administered as a liquid allowing it to fill any size and shape of defect, making it suitable for all lesion types. After a short exposure to ultra-violet light, GelrinC is converted into a solid implant completely filling in the lesion. The implant naturally degrades within 6-12 months and is gradually replaced with functional and durable cartilage. This FDA trial will evaluate the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. The study design overcomes the limitation of randomized control studies in this field, which is expected to result in faster patient enrollment and significantly reducing the time for product approval.
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