Forticell Bioscience Inc

Advancing Regenerative Medicine Through Development of Cellular Technology and Advanced Biomaterial Products

Forticell, (formerly Ortec International, Inc.), founded in 1991, was formed to commercialize the technology developed by Dr. Mark Eisenberg, an Australian general practitioner, to treat his son for the affects of a rare genetic disease, Epidermolysis Bullosa (EB). In a desperate attempt to save his son from having to undergo additional surgeries, Dr. Eisenberg discovered that he could create a substitute skin using cells from infant foreskins and delivering these in a collagen matrix. In 1987, Dr. Eisenberg successfully applied the technology he discovered, now known as OrCel®, on his son.

Today, Forticell Bioscience, Inc. (FORB.OB) has evolved into a fully integrated organization experienced in the development of natural biomaterials and tissue engineered cellular therapies. Forticell completed its initial public offering in January 1996 and is headquartered in Columbia University’s Audubon Biomedical Science and Technology Park, located in New York City, New York.

Forticell is a company focused on advancing regenerative medicine and stem cell therapy through the development and commercialization of innovative products by combining advanced cell technology and advanced biomaterials. Forticell’s lead product is OrCel® (Bilayered Cellular Matrix). Forticell’s current focus is the application of OrCel® to heal chronic and acute wounds. OrCel® is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair.

A pivotal clinical trial evaluating a cryopreserved version of OrCel® in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Forticell has already obtained FDA approvals for use of a non-frozen version of OrCel® in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Forticell approval to initiate a pivotal (Phase III) trial evaluating OrCel® for the treatment of diabetic foot ulcers.

Forticell recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads (Fibrin MB) and Haptides™. Fibrin MB have the potential to play a significant role in advancing stem cell therapy having demonstrated the ability to efficiently recover adult stem cells and allow for their growth, proliferation, and potential reimplantation into the patient. Haptides™ utilize proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These peptides have demonstrated the ability to significantly enhance cell attraction and attachment providing the potential to use Haptides™ in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets.