Healthcare Industry News: Stem Cell
News Release - September 18, 2012
Alphatec Spine Releases Alphatec NEXoss(TM) Nanostructure Bio-Active Matrix and Announces the First Patient ImplantCARLSBAD, 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 and 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 an engineered extracellular collagen bioscaffold that provides a physical structure for cell infiltration and attachment. The second is osteoconductive nano-structured bone crystals 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 and degenerative changes at L3-4, L4-5, and L5-S1 levels.
Dr. Stern chose Alphatec NEXoss as 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 an 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 Alphatec Spine to offer one of the most comprehensive biologics portfolios in the industry, which includes structural allografts, DBMs, scar 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 available 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 disease or trauma. The current "gold standard" for bone grafting incorporates an autograft of bone harvested from the patient's iliac crest. Although considered the gold standard, 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 allograft 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 disease transmission can never be completely ruled out.
The newest technological development for bone grafting products includes synthetic materials. Alphatec NEXoss is an advanced bone graft combining an engineered extracellular matrix bioscaffold proven as an ideal pathway for cell infiltration and osteoconductive nano-structured crystals 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 are one of the fastest growing markets in the spinal orthobiologics space 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 and 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 and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, the Company also markets its products in over 50 international markets through its affiliate, 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 Asia and Australia, the Company sells its and Scient'x's products through its and Scient'x's distributors.
Forward Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. 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 statements as a result of various factors. Forward-looking statements include, with respect to the agreement described in this press release, references to the size of the market for spinal orthobiologics and the adoption rate of the product by U.S. spinal surgeons. In addition, forward-looking statements include the Company's ability to develop and commercialize new products internally, and its ability to successfully pursue and commercialize complementary acquisitions of new products and technologies. The words "believe," "will," "should," "expect," "intend," "estimate" and "anticipate," variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements 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 and 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 ability 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 affecting cash flow or Alphatec Spine's ability to successfully control its costs or achieve profitability; uncertainty of additional funding; Alphatec Spine's ability to compete with other competing products and with emerging new technologies; product liability exposure; failure to meet all financial obligations in the Cross Medical Settlement; patent infringement claims and 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 Annual Report Form 10-K for the year ended December 31, 2011 filed on March 5, 2012 with the Securities and Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
Source: Alphatec Spine
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