Company background and status of clinical trials (from SEC filing)
ORTEC INTERNATIONAL, INC. (the "Company") has developed a proprietary technology which consists of a biologically active dressing to stimulate the repair and regeneration of human skin. The Company's product is intended to be utilized for the treatment of severe burn patients as well as for other types of wound healing and for reconstructive and cosmetic surgery. The Company believes that the successful regeneration of human skin creates the potential for wide commercial application.
The Company is a development stage company and to date has not sold any products. Its activities have been limited to human clinical tests of its product and research and development under an exclusive license relating to the Company's biological dressing. From March 12, 1991 (inception) to September 30, 1997, the Company spent an aggregate of $4,177,871 for research and development
In order to create a clinically useful biological dressing, the Company has duplicated the two major layers that form the human skin, the epidermis and the dermis. Dr. Mark Eisenberg, of Sydney, Australia, an officer and director of the Company and one of its largest shareholders, has been involved in biochemical and clinical research at the University of New South Wales in Australia for over twenty years, focusing primarily in treating the symptoms of a unique disease called Epidermolysis Bullosa ("EB"). The wounds resulting from EB are very similar to those caused by burns and require similar treatment. In 1987, through his work on EB, Dr. Eisenberg first succeeded in growing epidermal layers of human skin, which were successfully applied as an allograft on an EB patient. Dr. Eisenberg has since developed a biologically active dressing known as "Composite Cultured Skin", consisting of both the dermal and epidermal layers.
In March 1994, the Company commenced human clinical trials on burn patients under protocols approved by the Food and Drug Administration ("FDA"), which require testing of 120 patients. As of February 4, 1998, 16 patients have been treated under this program at three different hospitals. More trials will be necessary to test the safety and efficacy of the Company's product. From 1988 to 1996, the Company's product was used in skin replacement operations on 29 patients (of which 5 operations were skin replacement for burn patients) in Sydney, Australia. None of the Australian procedures were performed in accordance with the FDA approved protocols.
In 1996, the FDA approved the protocols of Rockefeller University Hospital in New York City for the use of the Company's Composite Cultured Skin for the treatment of non-healing skin ulcers of patients with EB. Under this FDA approved clinical trial protocol, ten to fifteen patients are required to be treated under this program. Rockefeller University has, as of the date of this Prospectus, conducted the human clinical trials on 11 EB patients under this program and may conduct up to an additional 4 human clinical trials on EB patients.
In December 1997 the FDA approved protocols of Washington Hospital Center in Washington, D.C., for the use of the Company's Composite Cultured Skin in a pilot clinical trial program for the treatment of 15 to 20 patients with donor site wounds. Donor sites are those areas of the body from which healthy skin is taken and transplanted onto a wound site (an "autograft" skin transplant), thus creating an additional wound at the donor site which then has to be treated. As of the date of this Prospectus, the human clinical trials under this program are expected to begin shortly. The protocols require follow-up evaluations of the patients for six months after the treatment.
The executive offices of the Company are located at 3960 Broadway, New York, New York 10032. Its telephone number is (212) 740-6999. |
