NEW YORK, June 22 /PRNewswire-FirstCall/ -- Ortec International, Inc. , a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that it has begun a pre-clinical study in rabbits to evaluate the capabilities of the Fibrin MB system to accomplish the full cycle of steps required to use a patient’s own stem cells therapeutically to regenerate large gaps in long bone tissue. The study involves a collaboration between the laboratories of Dr. Raphael Gorodetsky (Hadassah Ein-Kerem and Hapto Biotech, Israel) and Dr. Iri Libergal of the Department of Orthopedics at Hadassah Ein-Kerem Medical Center in Jerusalem, Israel. Complete results of the study are expected within six to eight months.
Commenting on the initiation of the study, Ron Lipstein, Ortec’s Vice Chairman and CEO, said, “The launch of this study is another key step toward accelerating the development and commercialization of the practical tissue regeneration therapeutic capabilities of our recently acquired Fibrin Microbead technology. We expect this study will provide us with the data from which we can design a clinical protocol and initiate a human clinical trial for this orthopedic indication.”
The Fibrin Microbead technology developed at Hapto Biotech, Israel, Ortec’s wholly owned subsidiary, is a proprietary matrix for the isolation, expansion and differentiation of matrix dependent cells, including Mesenchymal-type adult stem cells, and their potential reimplantation into the patient.
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 MB and Haptides(TM). Fibrin MB 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(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 of Elite Financial Communications Group, LLC,+1-407-585-1080, ortn@efcg.net, for Ortec International, Inc.
Web site: http://www.ortecinternational.com/
