Healthcare Industry News: diabetic foot ulcers
News Release - July 17, 2006
Cambrex and Ortec Submit to FDA a Humanitarian Device Exemption (HDE) for OrCel(R) to Treat Epidermolysis Bullosa PatientsWALKERSVILLE, Md., and NEW YORK, July 17 (HSMN NewsFeed) -- Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation (NYSE: CBM ), and Ortec International, Inc. (ORTN) are pleased to announce that they have submitted a Humanitarian Device Exemption (HDE) application to the US Food and Drug Administration (FDA) requesting approval to market cryopreserved OrCelŪ for the treatment of patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). The FDA has approximately seventy-five days to respond to the HDE application.
The FDA had previously advised that it could approve, without additional clinical data, an HDE supplement allowing the use of cryopreserved OrCelŪ in patients with RDEB undergoing hand reconstruction as well as to cover donor sites created during the surgery (the area where skin was removed from another part of the patient's body). In February 2001, the FDA granted Ortec an HDE for this indication for a non-cryopreserved version of OrCel.
An HDE is a FDA clearance that allows medical devices that provide safe treatment to be available in a prescribed manner for patients with rare medical conditions that affect fewer than 4,000 individuals in the US per year. An HDE application is similar in both form and content to a Pre-Market Approval (PMA) application, but approval can be granted by the FDA based on more limited clinical experience than that required for a PMA.
RDEB, the most severe form of Epidermolysis Bullosa (EB), is a devastating congenital skin disorder characterized by painful ulcerations and widespread, permanent scarring resulting in deformity of the hands and feet. As a result, many RDEB patients require repeated surgeries, resulting in a need for replacement skin, to allow greater use of their extremities. For more information about EB, please visit http://www.debra.org.
Cambrex Bio Science Walkersville, Inc. and Ortec International previously signed a multi-year agreement for Cambrex to manufacture, market and distribute OrCel in the United States. Upon approval by the FDA, Cambrex Bio Science Walkersville, Inc. will provide the product to patients.
Cambrex is a global, diversified life sciences company dedicated to providing products and services to accelerate and improve the discovery and commercialization of human therapeutics. The Company employs approximately 2000 worldwide. For more information, please visit http://www.cambrex.com.
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 OrCelŪ (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCelŪ to heal chronic and acute wounds. OrCelŪ 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 OrCelŪ 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 OrCelŪ 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 OrCelŪ for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads and Haptides(TM) developed by its wholly owned subsidiary HAPTO Biotech, Israel. Fibrin Microbeads 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.
Cambrex Forward Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and Rule 3b-6 under The Securities Exchange Act of 1934, including, without limitation, statements regarding expected performance, especially expectations with respect to sales, research and development expenditures, earnings per share, capital expenditures, acquisitions, divestitures, collaborations, or other expansion opportunities. These statements may be identified by the fact that words such as "expects", "anticipates", "intends", "estimates", "believes" or similar expressions are used in connection with any discussion of future financial and operating performance. The forward-looking statements contained herein are based on current plans and expectations and involve risks and uncertainties that could cause actual outcomes and results to differ materially from current expectations including but not limited to, global economic trends, pharmaceutical outsourcing trends, competitive pricing or product developments, government legislation and/or regulations (particularly environmental issues), tax rate, interest rate, technology, manufacturing and legal issues, changes in foreign exchange rates, performance of minority investments, uncollectible receivables, loss on disposition of assets, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials, the possibility that the value of the acquisition of PermaDerm(TM) cultured skin may not be realized or that our plans to obtain a Humanitarian Device Exemption, completion of clinical trials and commercialization of PermaDerm cultured skin in the United States may not be successful, the Company may not receive regulatory approval for its products, and the outcome of the evaluation of strategic alternatives.
For further details and a discussion of these and other risks and uncertainties, investors are cautioned to review the Cambrex 2004 Annual Report on Form 10-K, including the Forward-Looking Statement section therein, and other filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Ortec International Forward Looking Statements
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.
OrCelŪ is a registered trademark of Ortec International.
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