Posterior Spinal Fusion 'Locking' Implant From US Spine, Facet Fixation System(TM) (FFS), Wins ''2007 North American Frost & Sullivan Award for Product Differentiation Innovation'': FDA-cleared FFS is a less-invasive alternative to pedicle screws used in one- and two-level fusions "FFS represents our Company's first potential 'homerun' product." Joseph Mussey, Chairman and CEO, US Spine

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US Spine (http://www.us-spine.com) announced today that its novel Facet Fixation System(TM) (FFS) has won the "2007 North American Frost & Sullivan Award for Product Differentiation Innovation". This award is presented annually "to the company that has best demonstrated the ability to develop and/or advance products with more innovative capabilities than competing products ... Such innovation is expected to significantly contribute to the industry in terms of product performance and degree/rate of technical change," according to Frost & Sullivan (http://www.frost.com).

The very fact that there are no other devices intended for such use that are delivered using a 'gun' makes the Facet Fixation System unique

    The FFS is the only 'locking' facet implant in the market. Other available facet implants include simple screws, which are placed through the facet joint, with the distal tips buried into cancellous bone. The fixation strength in such cases is governed by the quality of the bone surrounding the distal portions of those screws. With the unique Facet Bolt, the screw is placed across the facet joint, with the distal portion penetrating the distal facet cortex. The tip of the screw is locked into a 'nut', creating a bolted construct across the facet. The strength of the fixation formed using the Facet Bolt depends more upon the compression created across the joint by the washer and nut on either end of the screw. "The very fact that there are no other devices intended for such use that are delivered using a 'gun' makes the Facet Fixation System unique," according to Frost & Sullivan.

"We are very pleased that our first potential 'homerun' product, the Facet Fixation System, has received such noteworthy attention from a premier industry authority as Frost & Sullivan," said Joseph Mussey, Chairman and CEO of US Spine. "We believe that the market for the FFS, which is scheduled to be released soon, is very significant. The 'gun' is designed as a single-use, disposable product and is expected to fall under current reimbursement codes for lumbar fusion. The FFS may be used in combination with anterior column support as a much faster, less-invasive alternative to pedicle screw fixation. But we also believe that the FFS can be used to stabilize the spine after a lumbar laminectomy, and there were more than 250,000 uninstrumented laminectomies performed in 2006--thus opening a potential $900 million market for us that is entirely new and unchallenged," said Mussey.

The Facet Fixation System(TM) consists of a single-use, disposable, two-triggered Facet Gun(TM). A squeeze of the Facet Gun's trigger is enough to facilitate spinal fusion. An adaptive titanium Facet Bolt resembling a screw is loaded into the Facet Gun. A locking nut is positioned at the end of the barrel, which is inserted into an L-shaped bracket. Precise position of the implant is guaranteed with the help of the bracket that holds the bones in place. On squeezing the first trigger, an inner metal tube is pushed forward to compress and offer enhanced alignment of the bolt. Squeezing the trigger for the second time propels the screw through both the vertebra and the nut. This action immobilizes the facet joint, providing the ideal environment for fusion to occur. "The uniqueness of the Facet Fixation System(TM) creates a highly differentiable market opportunity for US Spine," according to Frost & Sullivan.

US Spine is a privately held medical technology company that designs, develops, manufactures and markets proprietary spine implants that facilitate a less invasive approach to achieving tissue and motion preservation--thus yielding improved surgical outcomes, shorter hospital stays, and quicker recovery times.

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Ronald C. Trahan
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