Healthcare Industry News: CarriGen
News Release - November 5, 2009
Alphatec Spine, Inc. Enters Supply and Distribution Agreement With ETEX Corporation for Novel Biologics ProductsAgreement Allows Immediate Access to EquivaBone(R), a Unique Osteoinductive and Osteoconductive Material With Superior Handling Qualities
CARLSBAD, Calif., Nov. 5, 2009 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (Nasdaq: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 that it has entered into a supply and distribution agreement with ETEX Corporation, pursuant to which ETEX will provide Alphatec Spine non-exclusive rights to market and sell ETEX's EquivaBone and CarriGen(R) products in the United States and Europe, excluding Spain.
EquivaBone is a proprietary combination of demineralized bone matrix (DBM) and nanocrystalline calcium phosphate that sets hard in vivo. EquivaBone is cleared by the F.D.A. for use in posterolateral spinal fusion. This differentiated product is both osteoconductive and osteoinductive. Unlike other osteobiologics, EquivaBone sets hard and remains in place once implanted. Alphatec Spine will immediately begin marketing and selling EquivaBone in the United States.
CarriGen is a synthetic bone substitute that utilizes the same proprietary nanocrystalline calcium phosphate technology that is found in EquivaBone. CarriGen is currently under a 510(k) review with the F.D.A., and is not available for sale. As a pure synthetic, CarriGen is designed to set hard, and has compressive strength comparable to that of cancellous bone. CarriGen has high porosity which allows it to absorb saline and/or blood when mixed. Alphatec Spine expects to distribute CarriGen in the United States and Europe in the first half of 2010.
Additionally, pursuant to the supply and distribution agreement, Alphatec Spine has been granted a right of first negotiation with respect to certain technologies in the ETEX development pipeline for a non-exclusive distribution by Alphatec Spine.
"As part of Alphatec Spine's biologics strategy, we believe this supply and distribution agreement with ETEX will bolster our position in biologics solutions for spinal disorders," stated Dirk Kuyper, Alphatec Spine's President and CEO. Mr. Kuyper added, "We are extremely pleased to be a partner with ETEX as they have proven themselves to be a strong leader in the development of unique synthetic materials."
The bone graft and bone substitution market in the United States for 2009 is estimated to be greater than 300 million dollars.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq: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 design 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 spine products in Europe. In Asia, the Company markets a broad line of spine and orthopedic products through its subsidiary, Alphatec Pacific, Inc.
Also visit the Aging Spine Center, www.agingspinecenter.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. The Company is working with the National Osteoporosis Foundation as well as other clinical portals that provide peer-reviewed content, to populate the Aging Spine Center. The interactive website will enable patients to review pertinent information about disorders that affect the aging spine in an easy-to-understand format that includes videos, graphics and questions that should be asked of caregivers. Medical information will include published abstracts regarding the aging spine.
About ETEX Corporation
Established in 1989, ETEX Corporation develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes. A leader in bioresorbable bone substitute materials, ETEX focuses on expanding applications through combinations with cells, biologics, or therapeutic agents delivered in minimally invasive and easy to use systems. For more information, visit www.ETEXcorp.com.
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. These forward-looking statements include, but are not limited to: Alphatec Spine's ability to accelerate new product momentum, bring to market differentiated products and commercialize its product pipeline. 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, including, but not limited to, the following: Alphatec Spine's ability to meet its 2009 financial guidance, the growth rate of the spine market related to aging and elderly patients, uncertainty of success in developing new products or products currently in Alphatec Spine's pipeline, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including EquivaBone and CarriGen, by the surgeon community, failure to obtain FDA clearance or approval for new products, including CarriGen, or unexpected or prolonged delays in the process, including without limitation CarriGen, Alphatec Spine's ability to develop and expand its business in the United States, Asia and Europe, 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, 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 quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-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 Holdings
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