Osteotech, Inc. announced its new next generation grafting material: MagniFuse (TM) Bone Graft.
Robert M. Wynalek, Osteotech’s President - Domestic, commented, “The MagniFuse (TM) line of next generation bone regeneration products was developed in response to surgeon interest in a high performing, cost effective bone graft material. We believe that the distinctive properties of MagniFuse (TM) will redefine the bone grafting market and allow Osteotech to go head-to-head with bone morphogenetic protein products within the marketplace. This market is primed for a product that provides powerful bone formation and fewer complications, all at a cost effective price. We expect MagniFuse(TM) to be available for customers in the middle of 2009.”
MagniFuse(TM) is a unique combination of allograft bone within a polymer mesh that will provide targeted and contained delivery. The polymer mesh is made from a biodegradable suture material and is designed for effective cellular in-growth and complete resorption within three to six months, while not interfering with bone regeneration. The polymer mesh provides a controlled environment for proximate allograft interaction eliminating issues with graft site migration or irrigation that is often seen with currently available bone graft substitutes. As previously announced, Osteotech has received 510(k) clearance from the United States Food and Drug Administration for MagniFuse(TM) as a bone graft substitute, and as a bone void filler, for use in the spine, pelvis and extremities.
“The pre-clinical animal data for MagniFuse(TM) supports its use as a stand alone product in the Posterolateral Spine,” remarked Mohammed Attawia, MD, MS, Osteotech’s Vice President of Product Development. “Further pre-clinical work is ongoing and will be available for product launch. Our work to date indicated that the architecture of MagniFuse(TM) delivers performance beyond that of current bone grafting materials. We believe this breakthrough will allow us to redefine the standard of care for bone regeneration.”
Larry Shimp, Ph.D., Osteotech’s Principal Technology Officer, stated, “We believe the enhanced properties of MagniFuse(TM) go beyond that of many other products currently in the marketplace. We have developed a new, proprietary process that is designed to preserve a higher concentration of naturally occurring growth factors already present in human bone, while preserving the natural orientation and nanofibrous structure of the bone. The process of recovering a higher growth factor content from allograft bone is the subject of an outstanding patent application, and the technology that preserves the nanofibrous structure is covered by a patent and a pending patent application.”
For further information regarding Osteotech or this press release, please go to Osteotech’s website at http://www.osteotech.com.