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Market Launch of Anterior Lumbar Interbody Fusion System
Full Commercial Release of VIP of OsseoFix+ Cement System and VIP
Packaging System
Aging Spine Marketplace Overview by Industry Expert Robin Young
CARLSBAD, Calif., Feb. 24, 2009 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc. (NasdaqGM:ATEC - News), 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 several key activities that will take place during the 2009 Annual Meeting of the Academy of Orthopedic Surgeons being held February 25-28 in Las Vegas, NV at the Venetian/Sands EXPO. Of note, Alphatec Spine will release one new product and begin the full market launch of two new products, along with sponsoring a presentation by industry expert Robin Young to educate attendees on the aging spine marketplace.
Product Line Additions
Alphatec Spine announced the market launch of its Universal Novel(r) Anterior Lumbar Interbody Fusion (ALIF) System as well as the full commercial release of its OsseoFix+ Cement System and its Vacuum Infusion Packaging, or VIP system. The announcements were made in conjunction with the start of the 2009 Annual AAOS Meeting in Las Vegas.
The Universal ALIF is a comprehensive solution for both the Novel PEEK and AlphaGRAFT(r) Allograft implants in one system. The innovative inserter/distracter contained in the system provides for controlled distraction and precise insertion for Alphatec Spine's PEEK and allograft implants. The implants are available in multiple footprints and lordotic angles to provide solutions for all levels and patient anatomies. In 2008 it is estimated that 80,000 ALIF procedures were performed in the U.S., which created a $350 million market.
Alphatec Spine also announced the full market launch of the OsseoFix+ Cement System. The OsseoFix+ Cement System has a patented mixing and delivery system for treating vertebral compression fractures (VCF). Currently, the two most common procedures used to treat a VCF are kyphoplasty and vertebroplasty. A vertebroplasty procedure involves injecting bone cement directly into the VCF under high pressure, with the goal of stabilizing the fracture. In 2008 it is estimated that the U.S. market for the treatment of VCFs was $540 million.
``The OsseoFix+ Cement System provides surgeons with a considerable imaging advantage over other currently available cements,'' said Dirk Kuyper, Alphatec Spine's President and CEO. Mr. Kuyper continued, ``The Osseofix+ cement uses zirconium dioxide instead of the commonly used barium sulfate which provides surgeons with better visualization under fluoroscopy of the cement flow during the procedure. This can potentially provide an advantage in allowing the clinician to identify cement extravasation issues early and to stop the flow of cement. Cement extravasation into the spinal canal or venous vasculature occurs rarely but with potentially serious side effects. The cement has been extremely well received in Europe where it has been used with the OsseoFix(tm) Spinal Fracture Reduction System. OsseoFix, another innovative product from Alphatec Spine for vertebral compression fractures that targets aging spine patients, received its CE mark last year and has been commercially available in the EU since fourth quarter 2008.''
The VIP, Vacuum Infusion Packaging System was first released at the 2008 NASS meeting. The VIP system has now been expanded to be used with the AlphaGRAFT(tm) Profuse Demineralized Bone Scaffold product and the Alphagraft posterior lumbar implants. The VIP system is designed to provide rapid hydration of our Profuse and Alphagraft products, which in turn can reduce the length of the surgical procedure. Generally, allografts are soaked up to 20 minutes prior to insertion in order to achieve full hydration of the graft. The VIP system can reduce that hydration time to 30 seconds. In addition, the use of the VIP system decreases the brittleness of freeze-dried allograft. The extreme vacuum in the VIP system allows for infusion with the fluid of choice by the surgeon and ensure that fluids are distributed into the allograft rapidly in a uniform manner.
``Alphatec Spine is committed to introducing innovative products and technologies, such as the Vacuum Infusion Packaging System, the Universal ALIF System and the OsseoFix+ Cement System, all of which will help the surgeon achieve the best results for the patient,'' stated Mr. Kuyper.
Aging Spine Market Presentation
Additionally, at the AAOS Annual Meeting, industry expert Robin Young will make two presentations on the Aging Spine marketplace. The first presentation will be Wednesday, February 25 beginning at 1:30 pm. The encore presentation will be held Thursday, February 26 at 9:30 am. Both presentations will be held at the Alphatec Spine booth, number 4409 in Exhibit Hall C, Sands Expo Center.
Mr. Young is founder and president of RRY Publications and Robin Young Consulting Group., a firm specializing in evaluating and promoting orthopedic technologies and companies through a disciplined and comprehensive analysis of the industry, its participants, procedures, technologies and patient trends. He is an internationally recognized expert in his field, with over 20 years of experience and has been active in the development and funding of revolutionary products in the orthopedic market, such as spinal cages and nucleus replacement implants.
According to reports, the demographic of the age 65 and older population is the fastest growing demographic in the world. From 2005 to 2020 the U.S. Census Bureau projects a 50% increase in those age 65 and older, and by 2020, over 54 million people in the U.S. will be age 65 and older. ``There is a great opportunity for companies such as Alphatec Spine to focus its efforts to find better, more innovative answers to the problems facing spine surgeons and patients of the aging population,'' stated Mr. Young.
``We believe that treating the Aging Spine presents a number of unique challenges to surgeons and we are committed to developing innovative solutions to treat this fast growing population. Robin Young is extremely knowledgeable in this field and we value his insight and experience. We are enthusiastic about the opportunity to share this knowledge with our surgeon customers,'' stated Mr. Kuyper.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (NasdaqGM:ATEC - News). 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. For more information, please visit http://www.alphatecspine.com.
Also visit the Aging Spine Center, http://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.
The Alphatec Spine, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3520
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, including those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including the Universal ALIF System, the OsseoFix+ Cement System and the VIP packaging system, by the surgeon community, failure to obtain FDA clearance or approval for new products, or unexpected or prolonged delays in the process, 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.
Alphatec Spine, Inc.
Peter C. Wulff, Chief Financial Officer
(760) 494-6746
investorrelations@alphatecspine.com
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