Healthcare Industry News: diabetic foot ulcers
News Release - January 9, 2008
Ortec Shareholders Approve Corporate Name Change to Forticell Bioscience, Inc.New Stock Trading Symbol "FORB" Effective January 10, 2008
NEW YORK--(HSMN NewsFeed)--Ortec International, Inc. (OTCBB: OTCI ), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today the Company’s name has been changed to Forticell Bioscience, Inc. In connection with the new name, the Company’s stock ticker symbol has been changed to “FORB” effective January 10, 2008.
According to management of Ortec, the new name was proposed because it more appropriately reflects the Company’s comprehensive product line, which has the leading commercial candidate of OrCel®, a bilayered cellular matrix of engineered tissue to heal chronic and acute wounds, and two fibrin-derived advanced biomaterial technologies, Fibrin MicroBeads (FMB) and Haptides™, which were acquired in 2006. The “Forti” part of the new name is representative of the fortification enabling processes and strengthening aspects of the Company’s three core products. The “cell” part of the new name reflects the core competencies and activities surrounding cells and cell-based technologies. Above all, the Company has focused on the field of “Bioscience” for over 16 years, thus bridging the specific applications identified with Forticell with the common area of work in the biosciences.
Commenting on the name change, Ortec’s Chief Executive Officer and President, Dr. Costa Papastephanou, said, “The new name is clearly indicative of our comprehensive line of cellular biomaterial technologies and also is significant in marking recent improvements to the Company’s position and other near term catalysts. More importantly, the new identity underscores the evolutionary change we expect to take place in 2008 upon the anticipated approval from the Food and Drug Administration to market OrCel® in the United States, which catapults us into a commercial stage.”
Ortec International announced that it had submitted a Pre-Market Approval application to the Food and Drug Administration (“FDA”) for the use of OrCel®, a bilayered cellular matrix of engineered tissue to heal chronic and acute wounds, in the treatment of Venous Leg Ulcers (VLU). These ulcers are the most frequently occurring types of hard to heal wounds and are responsible for the loss of 2 million workdays per year in the U.S. alone and entail overall treatment costs estimated at $2.5 to $3.5 billion annually. The data from the Phase III Clinical Trial showed a significant improvement in wound healing in the OrCel® treated patients.
To date, the Company has raised more than $130 million to fund research and development efforts primarily related to OrCel® applications. Unlike many newly FDA approved products which face challenges in terms of post-approval market adoption, OrCel® may accelerate its marketing plans as it has already received insurance reimbursement of $1100 per application. Ortec has established a strategic alliance with Lonza for the manufacturing rights of its lead product. To protect the products, technologies, methods and processes that relate to the development of OrCel®, the Company holds four US patents, one EU patent covering thirteen countries, and ten patents in ten additional countries. In addition, there is one US patent pending, and eight more international patent applications under the Patent Cooperation Treaty have been filed.
“Forticell Bioscience is ready to hit the ground running in 2008,” continued Dr. Papastephanou. “With invigorated leadership, a broadened portfolio of regenerative tissue medicines, and our new name and branding, we are poised for successful market entry this year and to accelerate development of other technologies toward significantly increasing shareholder value.”
About Ortec International, Inc.:
Ortec International, Inc. (OTCBB: OTCI ) 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. Ortec’s lead product is OrCel® (Bilayered Cellular Matrix). Ortec’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 in October 2007. Ortec 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 Ortec approval to initiate a pivotal (Phase III) trial evaluating OrCel® for the treatment of diabetic foot ulcers.
In 2006 Ortec acquired Hapto, an Israeli biotechnology firm which has two fibrin-derived advanced biomaterial technologies, Fibrin MicroBeads (FMB) and Haptides™. FMB has 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, differentiation, 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, or transmembrane cell penetration, 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.
Additional information about Ortec is available on the Internet at www.ortecinternational.com.
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 would be “forward-looking statements.” 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.
Source: Ortec International
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