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Alphatec Spine Receives CE Mark for its OsseoScrew(TM) Spinal Fixation System and Its GLIF/ ARC(TM) Portal Access System

February 03, 2010 By: admin Category: CE & FDA, News

alphateclogoCARLSBAD, Calif., Feb. 2, 2010 — (HSMN NewsFeed) — 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 that the Company has received the CE Mark for commercial sale in the European Union and other jurisdictions for its OsseoScrew Spinal Fixation System and its Guided Lumbar Interbody Fusion (GLIF) System / Arc Portal System. The receipt of the CE Mark allows Alphatec Spine to begin selling these implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval. (more…)

Alphatec Spine Agrees to Acquire Scient’x Groupe SAS

December 18, 2009 By: admin Category: Financial News, News

scientxlogoalphateclogoAcquisition Creates Global Scale and Offers Revenues and Cost Synergies, Complements Alphatec Spine’s Product Portfolio and Enhances Aging Spine Focus Combined Entity to be Third-Largest Global Pure-Play Spinal Implant Company

CARLSBAD, Calif., Dec 17, 2009 (GlobeNewswire via COMTEX News 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 affecting the aging spine, announced today that it has entered into a definitive agreement to acquire Scient’x Groupe SAS, a spinal implant company headquartered in France. (more…)

Alphatec Spine, Inc. Enters Agreement with International Spinal Innovations, LLC

July 09, 2009 By: admin Category: Financial News, News

alphateclogoCARLSBAD, Calif.–(HSMN NewsFeed)–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 an agreement with International Spinal Innovations, LLC, pursuant to which International Spinal Innovations will provide Alphatec Spine worldwide license rights to intellectual property related to a stand-alone anterior lumbar interbody fusion (ALIF) device.

The International Spinal Innovations license, combined with intellectual property previously acquired from SpineVision S.A., will allow Alphatec Spine to develop and commercialize a zero-profile, self-locking interbody device for both ALIF and cervical procedures. Alphatec Spine expects to submit its stand-alone ALIF device to the U.S. Food and Drug Administration (FDA) for a 510k clearance in the first half of 2010. In addition, the Company anticipates launching the stand-alone ALIF product initially in Europe under a CE mark in the first half of 2010.

The 2009 interbody fusion market in the U.S. is estimated to be more than $950 million. The 2009 ALIF market represents the largest interbody segment in the U.S. with an estimated market in 2009 exceeding $350 million.

Dirk Kuyper“We are extremely pleased to have acquired this unique concept for stand-alone interbody devices,” said Dirk Kuyper, the Company’s President and CEO. Mr. Kuyper added, “The zero-profile, single-action locking implant is a substantial improvement over devices requiring screws or additional steps.” Mr. Kuyper continued, “This new technology license, combined with intellectual property previously acquired from SpineVision S.A., will enable Alphatec Spine to leverage a strong proprietary position in the largest segment of the interbody market. Both hospitals and surgeons are attempting to reduce procedure time and cost, and stand-alone implants that do not require supplemental posterior fixation are a logical progression in providing more cost-effective alternatives for patients, surgeons and hospitals.”

“This stand-alone device will be unique in that it will be designed to be inserted and locked into the superior and inferior vertebral endplates in a single step,” said J.P. Timm, the Company’s Vice President of Research & Development. Mr. Timm continued, “The simple insertion and fixation will result in a quicker procedure that should reduce the risk to the patient and cost to the hospital.”

Alphatec Spine Reaches Milestone of OsseoFix Adoption

June 21, 2009 By: admin Category: Clinical Studies, News

BY EDITOR, JUNE 19, 2009

Alphatec Holdings, Inc., 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 that, as of June 1,2009, over 115 patients in eight European countries have been treated with the OsseoFix Spinal Fracture Reduction System, the Company’s innovative product for the treatment of vertebral compression fractures. The first European training session was held at the University of Vienna in mid-December 2008. The first shipments of OsseoFix products into Europe occurred at the end of December 2008.

OSSEOFIXalphatec“We are pleased with the significant surgeon adoption of OsseoFix across Europe. Surgeons who are using the OsseoFix system benefit from the potential to improve patient outcomes by providing an enhanced ability for vertebral height maintenance while using less cement as a result of the permanent titanium implant. As this product represents our initial launch into the aging spine market, we are particularly pleased with the manner in which the adoption of OsseoFix appears to be accelerating. Over 60 patients were treated in May alone,” said Dirk Kuyper, Alphatec Spine’s President and Chief Executive Officer. Mr. Kuyper added, “Our next training lab, which will be held in July in Vienna, is oversubscribed, with 50 surgeons and over 70 total participants already enrolled in what will be our third training session.”

The OsseoFix system is not yet approved for sale in the United States and is currently under 510(K) review with the U.S. Food and Drug Administration.

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