EATONTOWN, N.J., Feb. 19 /PRNewswire-FirstCall/ -- Osteotech, Inc. , a leader in the emerging field of biologic products for regenerative healing, announced today that it has received ISO 13485:2003 certification for its quality management system. Osteotech received ISO certification for developing, manufacturing and marketing of biologic, biomaterial and device systems for musculoskeletal surgery and the processing of human bone and connective tissue for transplantation. Osteotech’s wholly-owned subsidiaries, OST Developpement SA and TB OsteoCentre Bulgaria EAD previously received ISO 9001 certification, and OST also previously received ISO 13485:2003 certification, for their quality management systems.
“We are very pleased to announce that we have received ISO certification for our U.S. quality management system,” said Sam Owusu-Akyaw, President and Chief Executive Officer of Osteotech. “The certification reinforces our commitment to maintaining a high quality processing facility and to ensuring the safety of those patients that utilize our products. Receiving the certification is an important milestone as we continue towards our goal to become a leader in regenerative and biologic healing.”
Osteotech’s facilities in Eatontown, New Jersey and Clermont-Ferrand, France are the processing sites for the Company’s allograft tissue grafts utilized in its broad portfolio of therapy-driven products focused on promoting regenerative and biologic healing. To date, Osteotech has successfully processed more than four million tissue grafts worldwide. The Company’s advanced technology platforms, all processed at its Eatontown facility, include Grafton(R) DBM and the Plexur(R) Biocomposite family of products as well as the DuraTech(TM) BioRegeneration Matrix, Osteotech’s leading product based upon its proprietary human collagen 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 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. These and other factors that could cause actual results to differ materially from such forward-looking statements 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 February 19, 2009 and the Company does not intend to update this information.
CONTACT: Mark H. Burroughs, +1-732-542-2800; or Media: Ashlea Kosikowski,
+1-910-509-3974
Web site: http://www.osteotech.com/
