Healthcare Industry News: Alphatec Holdings
News Release - October 5, 2010
Alphatec Spine, Inc. Releases PureGen(TM) Osteoprogenitor Cell Allograft to Facilitate Bone Regeneration and Announces First Patient Procedure Performed in the WorldCARLSBAD, Calif., Oct. 5, 2010 -- (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, today announced the release of its PureGen Osteoprogenitor Cell Allograft at the North American Spine Society Meeting (NASS) in Orlando, FL. PureGen is a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality. Unlike stem cell products that are currently commercially available, which have an unknown population of mesenchymal stem cells (MSCs) and are harvested from cadaveric donor tissue, PureGen delivers a similar potency of a pure adult MSCs without the need for cultural expansion. PureGen is the first pure adult stem cell to be released in the spinal market.
Dr. Carl Lauryssen, a Neurosurgeon and Director of Research and Education at Olympia Medical Center in Los Angeles, CA, completed the first procedure using PureGen. Pablo Pazmino, M.D. assisted in the surgery. Dr. Lauryssen has twice been awarded the Young Investigator Award from the American Association of Neurological Surgeons for his work on cervical disorders and stem cell research. The patient underwent a L4-S1 posterolateral fusion. "I believe in the promise of stem cells for treating spinal disorders as they pose minimal inflammatory side effects and have the capacity to repair and regenerate bone. I also believe the PureGen cell has the potential for providing surgeons with better clinical outcomes in spinal fusion," stated Dr. Lauryssen.
"We are committed to developing meaningful biologics solutions to improve surgical outcomes in the spine market, and this exciting new stem cell product has an enormous amount of potential. The PureGen osteoprogenitor cell is an extremely powerful cell that has both pluripotent potential and osteogenic differentiation. Our preclinical results underscore the ability of this cell to differentiate to bone faster and more efficiently than either bone marrow aspirate or mesenchymal stem cells," said Dirk Kuyper, the Company's President and CEO. Mr. Kuyper added, "It's exciting to add this significantly differentiated product to our portfolio. The PureGen osteoprogenitor cell will provide Alphatec Spine with an excellent position in the growing market of stem cell therapies for treating disorders of the spine, and will be a strong complement to the other innovative technologies in our core fusion and aging spine portfolios."
The PureGen osteoprogenitor cell allograft facilitates bone fusion, and is marketed exclusively by Alphatec Spine. PureGen is an adult stem cell that provides cellular and growth factors needed for osteogenesis, without the potential complications of autograft. Applied at the site of a musculoskeletal defect, PureGen mimics the regenerative environment of youthful tissues by increasing the concentration of stem cells available to repair tissue and build bone.
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 products in over 50 international markets through its subsidiary, Scient'x S.A., 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, South America and Latin America. In Asia and Australia, the Company markets its products through its subsidiary, Alphatec Pacific, Inc, and through Scient'x's distributors in China, Korea and Australia.
Also visit the Aging Spine Center, www.agingspine.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. Alphatec Spine 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 all the key 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.
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 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, including stem cells or the PureGen product, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including the PureGen product, by the surgeon community, failure to obtain FDA clearance or approval for new products, or unexpected or prolonged delays in the process, including without limitation the PureGen product, 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 Spine
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