September 27, 2016 9:50 PM 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 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

P.O.Box 260

Or-Akiva,  3060000

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: 64
Co-Founder and Chief Scientific Officer
Vice President of Business Development and General Manager of Israel Office
Vice President of Research & Development
Clinical Advisor
Compensation as of Fiscal Year 2016.

Regentis Biomaterials Ltd. Key Developments

Regentis Biomaterials Receives IDE Approval for Pivotal GelrinC Clinical Trial

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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Recent Private Companies Transactions

Type
Date
Target
Private Placement
February 5, 2016
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