SOURCE: Ortec International, Inc.

October 23, 2007 08:30 ET

Ortec Files PMA for OrCel® for VLU Indication

Clinical Data Demonstrates Significant Improvement Over Standard Therapy

NEW YORK, NY--(Marketwire - October 23, 2007) - Ortec International, Inc. (OTCBB: OTCI), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that it has filed the final safety and efficacy data required by the Food and Drug Administration (FDA) to evaluate its Pre-Market Approval (PMA) application for the use of OrCel® in the treatment of Venous Leg Ulcers (VLU). Ortec had filed the Chemistry, Manufacturing and Control (CMC) section of the current PMA earlier in the year. Ortec also previously developed a statistical plan with FDA for combining the data from its original, 2004 PMA filing with the additional data from this confirmatory trial in order to effectively double the number of patients evaluated. The combined data show a significant improvement in wound healing in the OrCel®-treated patients. The efficacy and safety results of the study show the following results for the OrCel® treated patients as compared to the standard of care (SC):

--  Higher incidence of wound closure
--  Accelerated wound closure
--  Reduced time to healing
--  Durability of wound closure
--  Reduced chronic pain associated with the study ulcer
--  No unusual or unexpected safety findings
    

The statistical analysis of the combined data from the original and more recent confirmatory trials shows that OrCel® treatment is statistically superior to treatment with SC alone. 50% of OrCel® patients versus 31% of SC patients had complete wound healing by day 84 (twelve weeks). OrCel® patients had a median healing time of 77 days, whereas for SC the median time to healing was not achieved. Analysis of the data shows statistically significant improvement between OrCel® and SC in the critical clinical end points of time to, and percentage of, patients achieving 100% healing (with p-values of 0.0141 and 0.0290, respectively). The rate of wound closure was also statistically significantly greater in the OrCel® treated subjects (p-value < 0.0001).

OrCel® is a cryopreserved (frozen), tissue-engineered Bilayered Cellular Matrix composed of a collagen sponge seeded with donor (allogeneic) keratinocytes and fibroblasts derived from newborn foreskin tissue. The cultured matrix contains live, growing cells that stimulate wound healing and skin regeneration in the patient. Because it is cryopreserved, OrCel® can be stored for months in the clinic, a major advance over current bilayered tissue-engineered skin products.

VLU are the most frequently occurring type of chronic wound. The prevalence of VLU rises dramatically with age, increasing to 1% of the population over age 60. In the U.S., VLU are estimated to be responsible for a loss of 2 million workdays per year, and entail overall treatment costs estimated of between $2.5 to $3.5 billion annually.

Costa Papastephanou, Ph.D., Ortec's Chief Executive, commenting on the filing said: "We are delighted that the results met our expectations for the trial. We are confident that the combined results of the confirmatory trial and the earlier trial support the approval of OrCel®, and we will be working with FDA to secure such approval as soon as possible. While we cannot accurately predict the timing of any FDA action, we believe, based on FDA precedent, that it could be achieved as early as mid-2008, allowing us to begin marketing OrCel® in 2008. Subject to our achieving FDA approval for the VLU indication in 2008, we plan on beginning Phase III clinical trials for OrCel® treatment of Diabetic Foot Ulcers in early 2009."

About Ortec International, Inc.

Ortec International, Inc. (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. 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 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.

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.

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