NEW YORK, May 23 /PRNewswire-FirstCall/ -- In a letter to Company shareholders, Ron Lipstein, Vice Chairman and Chief Executive Officer of Ortec International, Inc. , a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, stated:
“2005 was a year filled with challenges, resiliency and sustained progress. Mustering the fortitude to overcome the challenges that presented themselves, we now stand at a positive inflexion point. We look forward to the coming year with a sense of optimism based on the real value enhancing opportunities that lie ahead while ever mindful of the new challenges that inevitably are on the horizon.
“Our near term value enhancing opportunity is obtaining approval for the use of OrCel(R) in the treatment of venous leg ulcers. Towards achieving that end, we have recently completed enrollment of a pivotal (Phase III) trial designed to confirm the superiority of OrCel(R) over the standard of care therapy in the healing of difficult to heal venous leg ulcers. Within the next few months, after the completion of the treatment phase of the trial, we look ahead to analyzing the data and being able to submit a Pre-Market Approval (PMA) application to the Food and Drug Administration (FDA) later this year. We continue to believe OrCel(R) is a first in class product which will be marketed to patients with significant unmet medical needs. Clearly, approval of our product by the FDA should be a value-enhancing event for our Company.
“In an attempt to further enhance shareholder value, broaden investor interest and create additional value-enhancing opportunities, we recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads (FMB) and Haptides(TM). FMB 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 differentiation, proliferation, and potential reimplantation into the patient. Haptides(TM) 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. We believe Haptides(TM) can be of significant value in the development of product opportunities applicable to tissue regeneration, cosmetic tissue augmentation, wound healing, and orthopedics.
“We are implementing a business strategy for these newly acquired technologies that involves in-house development and our seeking licensing and collaborations for a range of applications. Adding these cutting edge technologies to our existing product and technology portfolio puts us squarely in the very exciting and growing field of stem cells and regenerative medicine and provides us with a number of synergistic technologies with which we can develop products. We believe our expertise and knowledge in the areas of cell biology, biomaterials and tissue regeneration which we have developed during the past 15 years, provide a solid platform from which we can effectively expand our focus to the development of stem cell and regenerative medicine products.
“To allow us to achieve our objectives and realize the value associated with our accomplishments, we will need to continue to access the capital markets. During the past year, we managed to attract new investors and received equity capital in excess of $11.5 million, and concurrent with the recent acquisition of our two new technologies, we raised an additional $6.1 million. As we continue to make progress and implement our business plan, with the continued support of our shareholders, we believe we can continue to raise the capital that will be necessary to reap the fruits of our labor.
“The success of a company is dependent on an array of factors, some which are controllable and those that are not. Together with our dedicated and valued employees, we continue to have the commitment and dedication to focus on those factors which we can control and maintain the confidence and demonstrated ability to react to those we cannot.
“We thank you, our shareholders, old and new, for your continued support which is critical to achieve our goals and allow us to grow the value of our Company,” concluded Lipstein.
About Ortec International, Inc.
Ortec International, Inc. (ORTN) 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(R) (Bilayered Cellular Matrix). Ortec’s current focus is the application of OrCel(R) 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.
A pivotal clinical trial evaluating a cryopreserved version of OrCel(R) in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has recently completed patient enrollment in a confirmatory trial and the data from this trial are expected to be integrated with the results of the pivotal clinical trial and submitted as a clinical supplement to its PMA filing. Ortec has already obtained FDA approvals for use of a non-frozen version of OrCel(R) 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(R) for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads (FMB) and Haptides(TM). FMB 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(TM) 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(TM) in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets.
For more information, visit Ortec’s website at http://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.
FOR MORE INFORMATION, PLEASE CONTACT Elite Financial Communications Group, LLC Dodi Handy, 407-585-1080 or via email at ortn@efcg.net
Ortec International, Inc.
CONTACT: Dodi Handy, Elite Financial Communications Group, LLC,+1-407-585-1080, or ortn@efcg.net, for Ortec
Web site: http://www.ortecinternational.com/
