Ortec and HAPTO Announce Positive Results with Biologically Active Biomaterial Applicable to Cosmetic Tissue Augmentation and Wound Healing Markets
Ortec and HAPTO Announce Positive Results with Biologically Active Biomaterial Applicable to Cosmetic Tissue Augmentation and Wound Healing Markets
May 23, 2005
Genertic Engineering News
Ortec International, Inc. (ORTN) and HAPTO Biotech, Inc. (HAPTO) announced positive pre-clinical in vivo results generated through their joint venture. The joint venture was established to combine Ortec's and HAPTO's respective technologies to develop a non cellular biologically active enhanced collagen biomaterial to promote the attraction and attachment of healthy cells for application to the wound healing, reconstructive, cosmetic, orthopedic, tissue regeneration and dental markets.
The results of the animal study, which are expected to be published shortly, showed that Ortec's proprietary collagen sponge scaffold, modified by attachment of HAPTO's proprietary peptides ("Haptides") that promote cell adhesion, had a higher cell binding potential than standard, untreated collagen. A histological analysis of sub-dermal implants of modified collagen discs in rats indicated that at day 8, collagen sponges treated with the Haptides exhibited greater stability, attracted more skin fibroblasts (30% greater), and resulted in enhanced new collagen deposition with reduced inflammatory reaction when compared to the standard collagen implant control.
Ron Lipstein, Ortec's Chief Executive Officer, commenting on the results, said, "We are pleased that our research efforts have produced the type of promising results we had been anticipating. The enhanced cell attraction and other properties demonstrated by our new biomaterial suggest that it can potentially make a major impact in the significant cosmetic and tissue augmentation markets."
The joint venture expects to continue its development work, which will include producing GMP grade product to be used in bio-safety and toxicology studies, and clinical evaluation of efficacy at a pilot level. Concurrently, licensing opportunities will be pursued with companies interested in co-developing and commercializing the technology for specific indications.
About Ortec International, Inc.
Ortec International, Inc., (ORTN), is a tissue-engineering company involved in the commercialization of a proprietary and patented technology to stimulate the repair and regeneration of human tissue. Ortec's current focus is the application of its OrCel(R) (Bilayered Cellular Matrix) to heal chronic and acute wounds. OrCel(R) 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. In addition to having received FDA approvals for the treatment of Epidermolysis Bullosa and donor sites in burn patients, a pivotal clinical trial has been completed for venous ulcers, and a PMA has been filed. Ortec is currently implementing a confirmatory trial as a clinical supplement to its PMA filing. In addition, the FDA has granted Ortec approval to initiate a pivotal trial in diabetic foot ulcers. Ortec believes that its platform technology may extend to the regeneration of other human tissue such as tendons, ligaments, cartilage, bone, muscle and blood vessels. For more information, visit Ortec's website at http://www.ortecinternational.com.
About HAPTO Biotech
HAPTO Biotech is positioning itself to become a leading technology provider in the field of tissue engineering through the development of fibrin derived platform technologies. HAPTO Biotech Inc, a Delaware Incorporated company, a start-up company established by Hadasit Medical Research Services and Development Ltd., the commercial subsidiary of the Hadassah Medical Organization, was established in 2000 and its wholly owned subsidiary, HAPTO Biotech (Israel) Ltd., was established in order to conduct its R&D operations. HAPTO's platform technology, Haptides(TM), utilizes proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These haptotactic peptides are used to enhance cell attraction and binding providing additional solutions in fields such as wound healing and skin regeneration, orthopedics, cell immunotherapy and potentially, drug delivery. For more information, visit HAPTO's website at http://www.hapto.co.il.
This news release may contain "forward-looking statements" for the purposes of the United States Securities and Exchange Commission's "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3B-6 under The Exchange Act, without limitation, statements regarding expected FDA approvals, clinical trial results, product performance, expectations with respect to sales, gross margins, research and development expenditures, earnings per share, capital expenditures, collaborations, or other expansion opportunities. These statements may be identified by words such as "expects", "anticipates", "intends", "estimates", "believes" or similar expressions in connection with any discussion of future financial and operating performance. The forward-looking statements contained herein involve risks and uncertainties that may cause results to differ materially from the Company's expectations including but not limited to, global economic trends, competitive pricing or product developments, government legislation and/or regulations, technology, manufacturing, legal and patent issues, suppliers, capital availability, personnel changes, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials. Investors are cautioned to review risk factors in the Company's filings with the United States Securities and Exchange Commission.
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