Biocomposite aids in bone rebuilding.
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Press Release Summary:
FDA-approved Plexur(TM) P incorporates overlapping cortical mineralized bone fibers with interconnected pores, which simulate bone structure, facilitate absorption of blood, and allow multiple pathways for bone forming cells to begin remodeling process. Available as granules and cylindrical plugs, porous and resorbable polymer scaffold is terminally sterilized and can be used to fill bony voids in patient's pelvis and extremities.
Original Press Release:
Osteotech Receives FDA Clearance for First Product Under Its Plexus Technology Platform
EATONTOWN, N.J., Feb. 8 -- Osteotech, Inc. (NASDAQ:OSTE) announced today that the Food and Drug Administration ("FDA") has cleared its 510(k) submission for an osteoconductive, bone/polymer biocomposite, which will be the first commercial product manufactured under Osteotech's proprietary Plexus Technology Platform. This new product, which will be marketed under the trade name Plexur(TM) P, is a porous, resorbable scaffold that can be used to fill bony voids of the pelvis and extremities.
Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to be able to introduce the Plexur(TM) P. Our internal team has done an excellent job developing this product and with this approval we expect to introduce additional products utilizing the Plexus Technology in the future."
Plexur(TM) P is an osteoconductive biocomposite of cortical mineralized bone fibers suspended in a resorbable porous polymer scaffold that has demonstrated controlled remodeling and resorption characteristics. Plexur(TM) P incorporates overlapping bone fibers with interconnected pores, which simulate bone structure, facilitate absorption of blood and allowing multiple pathways for bone forming cells to begin the remodeling process. Plexur(TM) P will initially be available as granules and cylindrical plugs, but ultimately, will be available in multiple forms including blocks, wedges and sheets. Plexur(TM) P uses proprietary processing steps that have been shown to inactivate viruses. Plexur(TM) P is also terminally sterilized.
Mr. Owusu-Akyaw concluded, "Plexur(TM) P will be officially introduced at the American Academy of Orthopedic Surgeons 2007 Annual Meeting, February 14 through 16, 2007, in San Diego, California. Plexur(TM) P will be positioned to compete against osteoconductive synthetic bone void fillers. We expect to begin distributing Plexur(TM) P in March 2007 at key centers of excellence to allow for the gathering of human clinical information before a worldwide launch of the product in the third quarter of 2007. This is in line with our strategy to use science to market osteo-biologic products."
The Plexus 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 controls over 17 patents and over 68 pending patent applications covering the Plexus Technology for human and xenograft bone tissue.
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a leading provider of human bone and bone connective tissue for transplantation and an innovator in the development and marketing of biomaterial and implant products for musculoskeletal surgery. For further information regarding Osteotech or this press release, please go to Osteotech's website at http://www.osteotech.com/.
CONTACT: Mark Burroughs of Osteotech, Inc., +1-732-542-2800
