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Old 08-17-2008, 11:51 AM
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Default OsseoFix system for Spinal Fractures - Trial started.

Alphatec Spine's OsseoFix Clinical Study Initiated
First Patient Treated by World-Renowned Spine Surgeon, Rudi Bertagnoli, M.D.

CARLSBAD, Calif., Jul 24, 2008 (PrimeNewswire via COMTEX News Network) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a leading medical technology company involved in the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that the first surgery with the OsseoFix(tm) Spinal Fracture Reduction System was performed on July 21, 2008 at the Bogen Centre in Germany. The surgery was performed by Rudolph Bertagnoli, M.D., Chief of Spine, St. Elizabeth Klinikum, Straubing, Germany, and a world-renowned spine surgeon.

"The patient was suffering from an acute osteoporotic T-12 compression fracture. The OsseoFix system was easy to use. The surgery went smoothly and I was able to regain considerable vertebral height and restabilize the vertebra in the patient. Following the surgery, the patient has minimal pain and has not required external support or bracing," said Dr. Bertagnoli.

Dr. Bertagnoli is the lead investigator in a 30-patient study of the OsseoFix that is being conducted by Alphatec in Germany. Following each OsseoFix procedure, each patient will be evaluated at appropriate post-operative time intervals to determine their level of pain relief and vertebral stability. After the completion of the study, the study results will be submitted for publication in a peer-reviewed spine surgery journal.

"The first OsseoFix surgery is another milestone that reflects Alphatec's dedication to improving the quality of life of older patients and treating the aging spine," said Dirk Kuyper, Alphatec's President and Chief Executive Officer. "Once cleared by the FDA, the OsseoFix Spinal Fracture Reduction System will be a valuable addition to Alphatec's product portfolio. We are pleased to offer spine surgeons increased options for treating patients with debilitating spine deformities, such as vertebral compression fractures. We expect OsseoFix to receive FDA clearance and be launched in the U.S. by late 2008."

Alphatec submitted pre-market notification to the FDA for a 510(k) clearance for OsseoFix in June 2008.

About Vertebral Compression Fractures and the OsseoFix Spinal Fracture Reduction System

According to the National Osteoporosis Foundation there were 700,000 osteoporotic vertebral compression fractures in the U.S., of which only one-third are estimated to be diagnosed. Common causes of vertebral compression fractures include osteoporosis, trauma, or a pre-existing disease at the fracture site.

Currently, the two most common procedures used to treat vertebral compression fractures are kyphoplasty and vertebroplasty. A kyphoplasty procedure involves injecting a balloon through a catheter into the damaged vertebra, inflating the balloon to restore height, and reinforcing the resultant space made by the balloon with bone cement. A vertebroplasty procedure involves injecting bone cement directly into the compressed vertebral body under high pressure, with the goal of stabilizing the fracture. Alphatec Spine designed and developed OsseoFix to expand the market for surgical solutions for vertebral compression fractures, with what it believes to be an improvement over the most common procedures being used today. OsseoFix is designed to allow for improved fracture reduction and designed to use less cement during a surgical procedure, both of which Alphatec believes reduces the risk of cement extravasation, reduces surgical complications and increases clinical efficacy.

About Alphatec Spine

Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device company involved in the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, primarily focused on treating conditions related to 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 and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, Alphatec Spine 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 Alphatec Spine Inc. - Home

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's ability to accelerate new product momentum, bring to market differentiated products and commercialize its product pipeline. Alphatec 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: 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's pipeline, including the launch of OsseoFix by late 2008, including those products that are intended to treat disorders prevalent in aging patients such as OsseoFix, failure to achieve acceptance of Alphatec's products, including OsseoFix, by the surgeon community, failure to obtain FDA clearance or approval for new products, including OsseoFix by late 2008, Alphatec's ability to compete with other competing products and with emerging new technologies, product liability exposure, patent infringement claims and claims related to Alphatec's intellectual property. Please refer to the risks detailed from time to time in Alphatec's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Alphatec 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.

This news release was distributed by PrimeNewswire, GlobeNewswire, Inc.

SOURCE: Alphatec Holdings, Inc.

Alphatec Spine, Inc.
Peter C. Wulff, Chief Financial Officer
760 494-6749
pwulff@alphatecspine.com

Cheryl B. Monblatt, Investor Relations
760 494-6746
cmonblatt@alphatecspine.com

(C) Copyright 2008 PrimeNewswire, Inc. All rights reserved.

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