Healthcare Industry News: bone graft
News Release - October 15, 2008
Integra LifeSciences Launches Accell Evo3, the Next Generation Accell TechnologyPLAINSBORO, N.J., Oct. 15, 2008 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (NasdaqGS:IART ) announced today that it has received 510(k) clearance from the United States Food and Drug Administration to market Accell Evo3(TM) in the US.
Accell Evo3(TM) is the latest generation in demineralized bone matrix and is composed of an optimized blend of particulate Demineralized Bone Matrix (DBM), the proprietary Accell(R) Bone Matrix (ABM), and a unique poloxamer Reverse Phase Medium. The poloxamer Reverse Phase Medium is a thermo-reversible carrier that thickens at body temperature and is more flowable at room temperature.
Accell Evo3(TM) contains more of the patented Accell(R) Bone Matrix than Integra's previous generation Accell(R) products. The optimized platform of Accell Evo3(TM) enables the bone healing process to take advantage of the naturally available bone proteins found in DBM and ABM. Accell Evo3(TM) has been specifically formulated to provide surgeons with the best possible intraoperative handling characteristics for proper utilization of the graft material, and is marketed in combination with a new custom designed open bore syringe.
Accell Evo3(TM) may be used as a bone graft extender in the spine, extremities and pelvis or as a bone void filler for the extremities and pelvis, and may replace the need to harvest bone graft material from the iliac crest, thus sparing the patient additional surgery and postoperative pain.
``Accell Evo3(TM) is truly an evolutionary advance in DBM technology that will separate it from the competition and provide a competitive alternative to other commercially available graft materials. Accell Evo3(TM) confirms Integra OrthoBiologics' commitment to drive innovation in bone fusion and healing,'' said Brian Larkin, President of Integra NeuroSciences.
bone grafts provide a foundation or scaffold for the patient's body to grow new bone, and can stimulate new bone production and bone fusion. The U.S. market size for bone graft substitutes in orthopedic spinal procedures is estimated at $1.4 billion. In 2008, an estimated 880,000 orthopedic procedures were performed in the United States, including over 500,000 spinal fusions. Additional applications are found in orthopedic trauma and reconstructive procedures.
Accell Evo3(R) is sold in the United States through the Integra OrthoBiologics distributor network consisting of approximately 50 independent distributors with over 300 sales representatives. The Integra OrthoBiologics distributor network is provided with additional marketing support by a direct sales team of 22 sales professionals. The Integra OrthoBiologics network already distributes Accell(R), DynaGraft(R), and OrthoBlast(R) demineralized bone matrices as well as the Integra Mozaik(TM) Osteoconductive Scaffold. This extensive product line allows the distributor network to provide a complete range of bone graft substitutes to orthopedic surgeons and neurosurgeons.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing and marketing of cost-effective surgical implants and medical instruments. The company's products are used to treat millions of patients every year, primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery. Integra's headquarters are located in Plainsboro, New Jersey, with research and manufacturing facilities throughout the world. http://www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the future use of the Accell Evo3(TM), Integra Mozaik(TM) Osteoconductive Scaffold, Accell(R), Accell TBM(R) (Total Bone Matrix), Accell Connexus(R), Dynagraft(R) and OrthoBlast(R) demineralized bone matrices. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use these products may affect the prospects for their use in clinical procedures. In addition, economic, competitive, governmental, technological and other factors identified under the heading ``Risk Factors'' included in section IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2007 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences
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