For Immediate Release
DR. COSTA PAPASTEPHANOU APPOINTED CEO
- Three New Board Members Also Added -
NEW YORK, NY - (Market Wire) - July 11, 2007 - Ortec International, Inc. (OTCI. PK), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that coincident with its recent $8.7 Million Series A Financing and Exchange of its $43 Million liability to Paul Capital for $10 Million of Series A Preferred Stock, it had appointed Dr. Constantin Papastephanou, its new Chief Executive Officer.
Dr. Papastephanou has been employed by Ortec since February 2001 as President and Chief Operating Officer. During his tenure he was instrumental in streamlining the OrCelĘ manufacturing process, and negotiating a favorable manufacturing contract with Lonza Walkersville. Prior to joining Ortec he was employed by Bristol Myers-Squibb for 27 years, the last 14 of which he was with ConvaTec, a multinational ostomy and wound care management division of Bristol-Myers Squibb. His last position at ConvaTec was as president of the global chronic care division, where he was responsible for that division's sales and marketing, clinical trials, research and development, manufacturing, quality assurance and regulatory affairs. He holds a Ph.D. in Biochemistry from the University of Miami as well as a Master of Science in Microbial Biochemistry from the University of London
Raphael Hofstein, President and CEO of Hadasit Ltd. in Israel, and a Director of Ortec since the Company acquired Hapto in 2006, commented: "Dr. Papastephanou has our full support and we are sure we have chosen the right leader to bring the Ortec team to the finish line. Costa is charged with seeing through the filing of the Pre-Market Approval with the FDA for our OrCelĘ product for the treatment of venous stasis ulcers, as well as preparing the Company for a product launch in 2008. On behalf of the Board of Directors, I wish Costa and his Ortec team my best wishes for success."
Dr. Papastephanou, stated, "I am delighted to be taking over the helm at Ortec and look forward to work at increasing shareholder value as we proceed with our FDA filing and commercialization plans. The latest round of financing confirms the confidence of our investors in the value of Ortec and its flagship product OrCelĘ. I look forward to the filing, in the next couple of months, of the PMA for the use of OrCelĘ in the treatment of venous leg ulcers and in creating new partnerships in the development of our Hapto technology where we are in discussions with a number of International companies."
Additionally, and also coincident with the financing transactions described above, John Leone, Shepard Goldberg and Mark Bagnall have joined the Board of Directors of the Company. Simultaneously, Mark Eisenberg, Steven Lilien, and Allen Schiff have resigned from the Board.
Mr. Leone is currently a partner at Paul Capital Partners with over 30 years of pharmaceutical industry experience. Most recently, he was President and Chief Executive Officer of Cambrex Corporation, a leading life sciences company. Previously, Mr. Leone was at Aventis, where he served as Senior Vice President and Chief Operating Officer of U.S. Commercial Operations. Among other initiatives, Mr. Leone spearheaded the successful integration of its predecessor companies, Rhone-Poulenc Rorer and Hoechst Marion Russell, to form Aventis. His industry experience also includes both domestic and international management roles with Pfizer and Wyeth. Mr. Leone received his BS degree in Engineering from the U.S. Military Academy at West Point, and his MBA from the University of Colorado.
Mr. Goldberg was recently Senior Vice President, Operations and Office of the President, at Emisphere Technologies, Inc. Emisphere is a publicly traded biopharmaceutical company charting new frontiers in drug delivery. Prior to joining Emisphere, Mr. Goldberg was President of Hydrovalve Co. Inc., a privately held manufacturing/distribution business with national and Canadian catalog sales. Mr. Goldberg has a Bachelor of Science degree in Electrical Engineering and Computer Sciences from the Polytechnic Institute in New York City and an MBA in Marketing and Business Administration from Adelphi University.
Mr. Bagnall recently served as Senior Vice President and Chief Finance and Operations Officer, at Metabolex, Inc. where he has served as a Director since February 2004. Metabolex, Inc. is a privately held pharmaceutical company focused on the development of drugs to treat diabetes and related metabolic disorders. In the 12 years prior to joining Metabolex, Mr. Bagnall held the top financial position at four life science companies: Metrika, Inc., a privately held diagnostics company, and three public biotechnology companies, Progenitor, Inc., Somatix Therapy Corporation, and Hana Biologics, Inc. During his career in biotechnology, he has managed several private and public financings, merger and acquisition transactions, and corporate licensing agreements. Mr. Bagnall is currently consulting and serving on the Board of Directors for Adventrix, a position he has held since February 2004. Mr. Bagnall received his Bachelor of Science degree in Business Administration from the U.C. Berkeley Business School and is a Certified Public Accountant.
"I am very excited about the addition of John Leone, Shepard Goldberg, and Mark Bagnall to Ortec's Board of Directors. Each bring with them a strong skill set and diverse expertise to the Company. They all have held senior positions in public and private companies and have a broad range of experience in the Pharmaceutical and Biotechnology Industry. I would like to thank Mark Eisenberg, Steven Lilien, and Allen Schiff for having helped lead the Company for many years," said Costa Papastephanou, newly appointed Chief Executive Officer, Ortec International, Inc.
These additions increase the number of Ortec's directors to six. In addition to Leone, Goldberg and Bagnall, the members of Ortec's board are Costa Papastephanou, Ph.D., Chief Executive Officer and President of Ortec, Rafi Hofstein, Ph.D., President and CEO of Hadasit Ltd., the Technology Holdings Company of Hadassah Medical Organization and Andreas Vogler, Managing General Partner of BioMedical Innovations Ltd.
About Ortec International, Inc.
Ortec International, Inc. (OTCI.PK) 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 OrCelĘ (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCelĘ to heal chronic and acute wounds. OrCelĘ 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 OrCelĘ in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has completed a confirmatory trial requested by the FDA, 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 OrCelĘ 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 OrCelĘ for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin MB and HaptidesT. 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 re-implantation into the patient. HaptidesT 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 HaptidesT 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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