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Osteotech Receives 13485:2003 ISO Certification; Company Meets International Standards for Medical Device Manufacturing
Date:2/19/2009

technology platform. Osteotech recently initiated a pivotal clinical trial to evaluate the safety of the DuraTech BioRegeneration Matrix for dura mater repair during craniotomy procedures. During the third and fourth quarters of 2009, the Company intends to file regulatory applications with the United States Food and Drug Administration and with the competent authority in certain other countries to obtain marketing clearance for DuraTech BioRegeneration Matrix.

"ISO certification validates the quality systems we have put in place to ensure the integrity of all of our products," added Greg Cannedy, Vice President of Regulatory Affairs at Osteotech. "Certification of our U.S. facilities complements the ISO certifications received by our European subsidiaries and marks an important step forward in bringing future products, including our DuraTech BioRegeneration Matrix, to market."

About ISO Certification

The International Organization for Standardization ("ISO") is a world-wide federation of national standards bodies. ISO certification is an international standard that specifies a quality management system for the development, production and distribution of medical devices and related services.

About Osteotech

Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in providing OsteoBiologic 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 contain forward-looking statements (as such are defined in the Private Secur
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SOURCE Osteotech, Inc.
Copyright©2009 PR Newswire.
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