Osteotech's Plexur M(TM) Biocomposite Receives FDA Clearance In Spine

Main Category: Bones / Orthopaedics
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 30 Jul 2008 - 1:00 PDT

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Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications. In spinal applications, Plexur M(TM) may be used in conjunction with autograft as a bone void filler. In March 2008, Osteotech received FDA clearance for Plexur M(TM) to be used in filling bony voids or gaps in the pelvis and extremities.

Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to receive FDA clearance for use of Plexur M(TM) in the spine. Plexur M(TM) is the second, of what we hope to be many more, bone-polymer biocomposites developed under our proprietary Plexur(R) Technology."

Mr. Owusu-Akyaw continued, "We are in the process of completing all of our internal activities for a limited launch of Plexur M(TM). By the end of the third quarter, we plan to introduce Plexur M(TM) to a small, select group of key surgeons who will utilize the product in a wide variety of orthopedic procedures, including spine, trauma and joints. We will utilize the knowledge gained from these surgeons to finalize our product uses, complete our technique guides and marketing materials and train our sales team."

The Plexur(R) Technology is designed to utilize bone tissue for procedure-specific surgical applications in combination with a wide variety of polymers. On a worldwide basis, Osteotech currently controls 33 patents and over 65 pending patent applications covering the Plexur(R) 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, this press release or the conference call, 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 July 29, 2008 and the Company does not intend to update this information.

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