EATONTOWN, N.J., July 29 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healing, today announced that in a July 24, 2009 letter to the Company, the French regulatory agency, afssaps, rescinded its December 17, 2008 order establishing restrictions on the importation and distribution of tissue products processed from donors procured by TB OsteoCentre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.
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"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."
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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 tissue products, were also inspected by afssaps, and the agency indicated that its inspection resulted in no audit findings.
"None of the audit issues raised by afssaps was a result of product contamination or deficiencies in the tissue grafts," said Greg Cannedy, Vice President of Regulatory Affairs at Osteotech. "Our goal was to resolve the deficiencies cited in the afssaps audit report as soon as possible. With this decision by afssaps we continue to build upon our excellent safety track record. Osteotech remains dedicated to providing proven technology and safe products that patients and surgeons can rely on to deliver superior outcomes to the patient."
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 in the repair of the musculoskeletal system through the development of innovative therapy-driven products that alleviate pain, promote biologic healing and restore function. For further information regarding Osteotech or this press release, please go to Osteotech's website at 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 July 29, 2009 and the Company does not intend to update this information.
SOURCE Osteotech, Inc.
