Healthcare Industry News: S.A.
News Release - September 18, 2012
Alphatec Spine Releases Alphatec NEXoss(TM) Nanostructure Bio-Active Matrix and Announces the First Patient Implant
CARLS.A., Calif., Sept. 18, 2012 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactureS.A.d markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today the first clinical use of Alphatec NEXoss, a next generation synthetic bone graft indicated for use in posterolateral spine fusions in conjunction with bone marrow aspirate, autograft bone and appropriate hardware.Alphatec NEXoss is composed of two unique patented technologies. The first iS.A. engineered extracellular collagen bioS.A.fold that provideS.A.physical structure for cell infiltration and attachment. The second is osteoconductive nano-structured bone cryS.A.s that have similar composition, structure and size as human bone. These two technologies function together to provide an ideal environment for a natural bone growth solution. Alphatec NEXoss is supported by in vitro and in vivo clinical data.
Last month, Alphatec announced the acquisition of exclusive U.S. distribution rights to market the product under its own brand name called Alphatec NEXoss. Alphatec NEXoss is FDA-cleared for commercial sale.
The three-level posterior lumbar fusion procedure was performed by Joseph Stern, M.D., a neurosurgeon in private practice in Greensboro, NC. The patient was treated for progressive worsening of spondylolisthesis of L3-4 and L5-S1 with spinal stenosiS.A.d degenerative changeS.A. L3-4, L4-5, and L5-S1 levels.
Dr. Stern chose Alphatec NEXosS.A. the fusion graft material based on the proven safety and effectiveness of the product technology. "I am very pleased with the excellent handling properties of Alphatec NEXoss," said Dr. Stern. The mixing and delivery system has been designed with the surgeon in mind and provideS.A.very easy and effective way to deliver the graft both in open and MIS cases."
"Alphatec NEXoss iS.A. excellent product and an important addition that strengthens our biologics portfolio with a synthetic bone matrix offering," said Les Cross, Alphatec Spine's Chairman and Chief Executive Officer. "What makes NEXoss effective is that its patented structure is nearly identical in composition to natural human bone.
"Having a synthetic bone graft solution enableS.A.phatec Spine to offer one of the most comprehensive biologics portfolios in the industry, which includes structural allografts, DBMs, S.A. barriers, a stem cell allograft and now synthetic bone grafts. In addition to the many internal new product development programs we have underway, this supply agreement is representative of the many opportunitieS.A.ailable in the marketplace today that will help the Company maintain a continuous flow of new products."
Many surgical procedures of the spine require bone grafts to regenerate bone that has been removed or damaged due to diS.A.e or trauma. The current "gold S.A.dard" for bone grafting incorporateS.A. autograft of bone harvested from the patient's iliac crest. Although considered the gold S.A.dard, use of autograft is not without its significant disadvantages. In addition to the need for a second operation to harvest the bone from the iliac crest, the supply of harvested autograft is limited and the patient may experience significant post-operative pain at the harvest site for an extended period of time.
A second type of bone used in grafting procedures useS.A.lograft bone derived from processed human cadaver bone. While allograft bone has been used for many years, it also has some disadvantages in that the risk of diS.A.e transmission can never be completely ruled out.
The newest technological development for bone grafting products includes synthetic materials. Alphatec NEXoss iS.A. advanced bone graft combining an engineered extracellular matrix bioS.A.fold proven aS.A. ideal pathway for cell infiltration and osteoconductive nano-structured cryS.A.s that mimic the composition, structure and size of human bone, providing a natural bone growth solution.
The spinal orthobiologics market is estimated to be approximately $2 billion annually in the U.S. SyntheticS.A.e one of the fastest growing markets in the spinal orthobiologics S.A.e and are expected to grow at a compound annual growth rate of approximately 10% over the next 5 years. (Source:i-Data)
About Alphatec Spine
Alphatec Spine, Inc. iS.A.wholly owned subsidiary of Alphatec Holdings, Inc. (ATEC). Alphatec Spine iS.A.medical device company that designs, develops, manufactureS.A.d markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company's mission is to combine world-class customer service with innovative, surgeon-driven products that will help improve the aging patient's quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis, stenosiS.A.d other aging spine deformities, improved minimally invasive productS.A.d techniqueS.A.d integrated biologics solutions. In addition to its U.S. operations, the Company also markets its products in over 50 international markets through itS.A.filiate, Scient'x S.A.S., via a direct sales force in France, Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In Latin America, the Company conducts its business through its subsidiary, Cibramed Produtos Medicos. In Japan, the Company markets its products through its subsidiary, Alphatec Pacific, Inc. In the rest of AS.A.and Australia, the Company sells itS.A.d Scient'x's products through itS.A.d Scient'x's distributors.
Forward Looking S.A.ements
This press release may contain "forward-looking S.A.ements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve riskS.A.d uncertainty. Such S.A.ementS.A.e based on management's current expectationS.A.d are subject to a number of riskS.A.d uncertainties that could cause actual results to differ materially from those described in the forward-looking S.A.ements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking S.A.ementS.A. a result of various factors. Forward-looking S.A.ements include, with respect to the agreement described in this press release, references to the size of the market for spinal orthobiologicS.A.d the adoption rate of the product by U.S. spinal surgeons. In addition, forward-looking S.A.ements include the Company'S.A.ility to develop and commercialize new products internally, and itS.A.ility to successfully pursue and commercialize complementary acquisitions of new productS.A.d technologies. The words "believe," "will," "should," "expect," "intend," "estimate" and "anticipate," variations of such wordS.A.d similar expressions identify forward-looking S.A.ements, but their absence does not mean that a S.A.ement is not a forward-looking S.A.ement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking S.A.ements include, but are not limited to; the uncertainty of success in developing new products or products currently in Alphatec Spine's pipeline; the uncertainty of success in acquiring new products or technologies; the successful launch of the Company's new productS.A.d the products in its development pipeline, including the product discussed in this press release; failure to achieve acceptance of Alphatec Spine's products by the surgeon community; failure to successfully implement streamlining activities to create operating cost savings; failure to successfully begin in-house manufacturing of certain products; failure to obtain or maintain FDA clearance or approval for products, including the product discussed in this press release, or unexpected or prolonged delays in the process; Alphatec Spine'S.A.ility to develop and expand its U.S. and/or global revenues; continuation of favorable third party payor reimbursement for procedures performed using Alphatec Spine's products; unanticipated expenses or liabilities or other adverse eventS.A.fecting cash flow or Alphatec Spine'S.A.ility to successfully control its costs or achieve profitability; uncertainty of additional funding; Alphatec Spine'S.A.ility to compete with other competing productS.A.d with emerging new technologies; product liability exposure; failure to meet all financial obligations in the Cross Medical Settlement; patent infringement claimS.A.d claims related to Alphatec Spine's intellectual property. Please refer to the risks detailed from time to time in Alphatec Spine's SEC reports, including itS.A.nual Report Form 10-K for the year ended December 31, 2011 filed on March 5, 2012 with the SecuritieS.A.d Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaimS.A.y intention or obligation to update or revise any forward-looking S.A.ements, whether aS.A.result of new information, future events, or otherwise, unless required by law.
Source: Alphatec Spine
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