Osteotech's Plexur P(TM) Receives FDA Clearance As Bone Void Filler And Bone Graft Extender In Spine

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals;  IT / Internet / E-mail
Article Date: 26 Apr 2008 - 0:00 PDT

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Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for the Plexur P(TM) Biocomposite for use in spinal applications as a bone void filler and as a bone graft extender. Previously, Osteotech received FDA clearance for Plexur P(TM) for use in filling bony voids of the pelvis and extremities.

Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to receive FDA clearance for the use of our Plexur P(TM) product in the spine. We continue to receive many favorable comments from orthopedic surgeons about the efficacy of Plexur P(TM) and we will immediately offer our Plexur P(TM) product to spine surgeons supported by the clinical information and experience we have gained over the last year. Our proprietary Plexur(R) Technology continues to be one of the keys to our product pipeline and future growth initiatives."

To date, the Plexur P(TM) Biocomposite has been used by a variety of surgeons in tibial plateau fractures, tibial osteotomies and a variety of foot and ankle procedures, and can now be used in the spine. Our Plexur P(TM) product can be combined with our proprietary Grafton(R) DBM, local bone or our new Kinesis(TM) BMAC(TM) cellular system. Plexur P(TM) is available as granules, cylinders, blocks, wedges and sheets. For more information about the Plexur P(TM) Biocomposite, please go to our websites at http://www.plexur.com or http://www.osteotech.com.

The Plexur(R) Technology uses bone tissue for procedure specific surgical applications in combination with a wide variety of polymers. On a world-wide basis, Osteotech controls over 33 patents and over 65 pending patent applications covering this technology for human and xenograft bone tissue.

Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in providing OsteoBiologic 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 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. 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 April 25, 2008 and the Company does not intend to update this information.

Osteotech, Inc.
http://www.osteotech.com

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