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Osteotech Resumes Shipments of Bulgarian Tissue
Date:7/29/2009

EATONTOWN, N.J., July 29 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, today announced that in a July 24, 2009 letter to the Company, the French regulatory agency, afssaps, rescinded its December 17, 2008 order establishing restrictions on the importation and distribution of tissue products processed from donors procured by TB OsteoCentre Bulgaria EAD ("OCBG"), a subsidiary of Osteotech. During its inspections, afssaps obtained and tested a number of samples of Osteotech's proprietary Grafton(R) DBM processed from OCBG donor tissue and found no instances of contamination. As a result of this favorable outcome, Osteotech lifted its self-imposed temporary suspension and will begin distributing tissue grafts processed from OCBG donors to its foreign distributors immediately.

"The results of the afssaps inspections and testing demonstrate the safety and effectiveness of Osteotech's proprietary processing technologies," stated Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "Over the last 17 years, Grafton has been proven to outperform competitive bone grafting solutions, a position that is supported by extensive clinical studies that have demonstrated efficacy and safety. Based upon our superior processes and dedication to quality, we have successfully distributed more than four million tissue grafts, including 8 million ccs of Grafton, without a confirmed case of disease transmission."

The afssaps action came after a re-inspection of OCBG by afssaps in which OCBG successfully closed the audit deficiencies associated with donor record maintenance and traceability with the OCBG procurement program. Osteotech's processing facilities, which process the OCBG donor tissue into implantable tiss
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SOURCE Osteotech, Inc.
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Related biology technology :

1. Osteotech Reports First Quarter 2009 Financial Results
2. Osteotech Announces First Quarter 2009 Earnings Release and Conference Call
3. Osteotech Reports Fourth Quarter and Full Year 2008 Financial Results; Company Plans Three Product Launches and Unveilings in 2009; Will Provide 2009 Guidance During Conference Call on March 5, 2009 at 9:00 a.m. EST
4. Osteotech Announces Stock Repurchase Program
5. Osteotechs Next Generation Grafting Material, MagniFuse(TM) Bone Graft, a Breakthrough in Bone Regeneration; MagniFuse(TM) Bone Graft seeks to redefine the standard of care in the U.S. bone graft substitute market estimated to be in excess of $1.2 billio
6. Osteotech Reports 2008 Third Quarter Financial Results
7. Osteotech Receives FDA Clearance for its Next Generation Grafting Material
8. Osteotech Announces Third Quarter Earnings Release and Conference Call Schedule
9. Cato T. Laurencin, M.D., Ph.D. to Join Osteotech Board of Directors
10. Osteotechs Plexur M(TM) Biocomposite Receives FDA Clearance in Spine
11. Osteotechs Plexur(R) Technology to Be Used in Craniofacial Reconstruction Program Funded by the Armed Forces Institute of Regenerative Medicine
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