EATONTOWN, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Osteotech, Inc. , a leader in the emerging field of biologic products for regenerative healing, announced today that it has submitted a 510(k) application to the United States Food and Drug Administration (FDA) to obtain marketing clearance for the use of its Duratech(TM) BioRegeneration Matrix to repair or replace the dura mater (the outermost membrane surrounding the brain) in various cranial surgical procedures. This filing is based, in part, on data collected during the Company's human clinical study, which demonstrated the safety and performance of Duratech compared to currently marketed predicate dura substitute devices. Based on available data, Osteotech estimates that the annual market for dura repair substitutes is approximately $100 million.
"Our 510(k) application for Duratech is another key milestone in our new product development initiatives and is the first step in the commercial development of our HCT(TM) (human collagen technology) platform," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "We believe HCT will eventually support a family of first-in-class, procedure-specific biologic products with a total addressable market opportunity in excess of $1 billion. We believe the data in our filing demonstrates Duratech's safety and performance in the challenging neurosurgical environment and that this data will pave the way in developing the HCT platform for a variety of surgical applications. Duratech was developed in response to the physician community's need for a single biomaterial that has exceptional handling, is flexible yet strong and can be cut, shaped and sutured to fit surgical needs. Once cleared by the FDA, we believe Duratech's unique characteristics will give us a competitive advantage in the marketplace."
Duratech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. The Duratech 510(k) filing included data on 60 patients who underwent a variety of cranial surgical procedures utilizing Duratech where dura mater repair or replacement was required. The patients were evaluated at 30 and 90 day time points post-operatively to assess the safety and performance of Duratech.
About Duratech(TM) BioRegeneration Matrix
Utilizing Osteotech's HCT platform, Duratech is an engineered human collagen biomaterial that provides a semi-permeable scaffold and facilitates cellular in-growth and healing. Duratech is designed to be utilized to repair or replace the dura mater, a fibrous membrane that protects the brain, when the dura mater has been compromised due to injury or surgery. Osteotech's proprietary collagen technology platform is supported by three pending patent applications.
In addition to Duratech, which is expected to launch immediately after clearance by the FDA, Osteotech plans to introduce additional tissue products based upon its HCT platform over the next several years that address patient needs and expand the addressable market for this innovative technology, including rotator cuff repair, wound care applications and abdominal wall reconstruction.
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in providing biologic solutions for regenerative medicine to support surgeons and their patients through the development of innovative therapy-driven products that alleviate pain, promote regenerative and biologic healing and restore function. For further information regarding Osteotech or this press release, please go to Osteotech's website at http://www.osteotech.com/.
Certain statements made throughout this press release that are not historical facts are forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995) regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company's ability to develop and introduce new products, differences in anticipated and actual product and service introduction dates, the ultimate success of those products in the marketplace, the continued acceptance and growth of current products and services, the impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. All information in this press release is as of December 17, 2009 and the Company does not intend to update this information.
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Web Site: http://www.osteotech.com/