Baxano Surgical Announces First Clinical Use of the Avance MIS Pedicle Screw System
June 30 2014 - 7:30AM
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 the first case utilizing the Avance™ MIS
Pedicle Screw System was recently performed by Dr. Sameer Mathur in
Cary, NC. The innovative design of Avance provides for an
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 through the end of third quarter of 2014 and is
planned for full launch in the fourth quarter of 2014.
"The first clinical use of the Avance pedicle screw system
represents a major milestone in the evolution of Baxano Surgical,"
stated Ken Reali, President and CEO of Baxano
Surgical. "Avance will significantly enhance our ability to
service our surgeon customers' lower lumbar fusion needs where we
can now offer a complete fusion solution coupled with our AxiaLIF
and VEO interbody fusion implants. This is an important
strategic initiative that increases our presence in the rapidly
growing MIS spine arena."
"The Avance system provides a step forward with a true MIS
approach to spinal fixation by minimizing tissue trauma and
eliminating additional rod insertion incisions," stated spine
surgeon Sameer Mathur, M.D. "The system's low-profile design,
combined with Avance's intraoperative flexibility and range of
options to meet surgeon preferences makes for a durable, versatile,
easy-to-use solution."
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, the iO-Tome® instrument, which
rapidly and precisely removes bone, specifically the facet joints,
which is commonly performed in spinal fusion procedures and Avance,
an MIS pedicle screw system used in lumbar fusion procedures.
Baxano Surgical was founded in May 2000 and is headquartered in
Raleigh, North Carolina. For more information, visit
www.baxanosurgical.com.
AxiaLIF, VEO, iO-Tome and iO-Flex are all registered 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.
CONTACT: Baxano Surgical Inc.
Tim Shannon, Chief Financial Officer
919-926-8762
or
Stonegate, Inc.
Casey Stegman
214-987-4121
casey@stonegateinc.com