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FDA Clearance Means New Product, Revenues For Baxano

By Jenny Callison, posted Apr 10, 2014
Baxano Surgical, a medical device company focused on minimally invasive products to treat degenerative conditions of the spine, announced Thursday that it has received U.S. Food and Drug Administration clearance for a new product related to the company’s existing spinal fusion technologies.
Raleigh-based Baxano, which maintains a presence in Wilmington, earned clearance for its Avance MIS Pedicle Screw System, which the company’s news release stated “may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies.”
Company president and CEO Ken Reali said that the company was “very excited” about gaining clearance for the system.
“We’ve been working on this [system] for the past 22 months, working with two Raleigh-based surgeons. It’s synergistic with our existing products,” he said.

Baxano Surgical – formerly Trans1 – currently markets the AxiaLIF family of products for single and two-level lower lumbar fusion, the VEO lateral access and interbody fusion system, the iO-Flex system, a proprietary set of flexible instruments used by surgeons during spinal decompression procedures, and the iO-Tome instrument, which removes bone in spinal fusion procedures, according to the release.
Pedicle screws are used sometimes in a spinal fusion to add extra support and strength to the fusion while it heals. Pedicle screws are placed above and below the vertebrae that were fused.
Sameer Mathur and Nael Shanti are the two surgeon designers of the Avance system. They said in the release that the Avance system is designed to minimize tissue trauma and invasiveness of fusion procedures.
Reali said that, until now, surgeons have used pedicle screws from other sources in tandem with Baxano’s spinal fusion devices. Now Baxano offers them the full range of products designed to be used together.
“There’s a significant upside for us financially,” he said, adding that Baxano will also have greater control over the quality of its techniques now that it makes its own pedicle screw system.
Reali said that the Avance system will launch later this quarter and will continue in limited market release through the third quarter of 2014. A full launch is planned for the fourth quarter.

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