Baxano Surgical Receives 510(K) Clearance For The Avance MIS Pedicle Screw System
RALEIGH, N.C., April 10, 2014 -- Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug Administration 510(k) clearance (k133743) of its Avance™ MIS Pedicle Screw System, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. The innovative design of Avance provides a quick and easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The Avance system will be in limited market release in the second and third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.
“This FDA clearance represents a significant addition to Baxano Surgical’s MIS product portfolio and offers surgeon and hospital customers an additional solution for their lumbar fusion procedures,” stated Ken Reali, President and CEO of Baxano Surgical. “Avance will significantly enhance our ability to meet customer needs and gain a stronger foothold in the MIS fusion market.”
“The Avance system provides a truly percutaneous approach designed to minimize tissue trauma and eliminate additional rod insertion incision,” stated spine surgeon Sameer Mathur, M.D. “The scientific engineering used to design Avance lowers the construct’s overall profile, increases intraoperative flexibility and enhances lock down security,” stated Nael Shanti, M.D. Drs. Mathur and Shanti are surgeon designers of the Avance system.
About the Avance MIS Pedicle Screw System
The Avance MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. The Avance system accommodates single level degenerative procedures as well as multi-level, complex pathologies from T1 to S1.
About Baxano Surgical, Inc.
Baxano Surgical, Inc. is a medical device company focused on designing, developing, and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region. Baxano Surgical 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 rapidly and precisely removes bone, specifically the facet joints, which is commonly performed in spinal fusion procedures. Baxano Surgical was founded in May 2000 and is headquartered in Raleigh, North Carolina. For more information, visit www.baxanosurgical.com.
Avance, AxiaLIF, VEO, iO-Tome, iO-Flex and MicroBlade Shaver are all trademarks of Baxano Surgical.
Forward Looking Statements
This press release includes statements that are based on our current beliefs and assumptions. These statements constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the pace of adoption of our product technology by spine surgeons, the outcome of coverage and reimbursement decisions by the government and third party payors, the success of our continuing product development efforts, the effect on our business of existing and new regulatory requirements, our ability to raise additional capital, our ability to comply with our settlement agreement and Corporate Integrity Agreement with certain entities of the U.S. government, stockholder class action lawsuits, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with Baxano Surgical’s business, please review the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent reports. You are cautioned not to place undue reliance on these forward looking statements, which are based on Baxano Surgical’s expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
Westwicke Partners
Mark Klausner, 443-213-0501
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