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Osteotech Submits 510(k) Application to FDA for Clearance of its Duratech(TM) BioRegeneration Matrix
Date:12/17/2009

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.

About Osteotech

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

SOURCE Osteotech, Inc.
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