CARLSBAD, Calif.–(BUSINESS WIRE)–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.
“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.”