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License bolsters intellectual property position surrounding a
stand-alone ALIF device with single step insertion and fixation to
reduce procedure time and cost
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Alphatec Spine to launch stand-alone ALIF product in the U.S.
and Europe in 2010
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.
