|[February 19, 2013]
Baxano Announces Milestone in Clinical Use of iO-Flex® Technology
SAN JOSE, Calif. --(Business Wire)--
Baxano, Inc. announced today that it has surpassed a significant
milestone with over 5,000 patients, representing nearly 10,000 neural
foramen, treated with the iO-Flex® System for lumbar spinal
decompression since the time the product became commercially available
in late 2009.
"Innovative technologies must advance patient care and provide value to
the healthcare system," reported Sylvain Palmer, MD, from Mission Viejo,
California. "Baxano's clinical results and commitment to demonstrate
improvement in cost-effective patient care are extremely encouraging for
patients suffering from lumbar spinal stenosis."
News of this treatment milestone comes on the heels of Baxano's
announcement late last year that it had reached a key clinical milestone
in its post-market iO-Flex Study with the last of the six-month clinical
and economic follow-up data from patients having been collected, as well
as news of iO-Flex receiving CE Mark approval allowing for future
expansion into European markets. Baxano also received FDA clearance late
last year for iO-Tome™, an instrument used in fusion with the potential
to revolutionize spine surgery by allowing minimally invasive
"We are extremely encouraged by the robust adoption of the iO-Flex
System by healthcare providers as evidenced by this 5000th patient
landmark," said Tony Recupero, President and Chief Executive Officer of
Baxano. "The combinaion of clinical evidence, positive patient
outcomes, and cost-effective solutions we've achieved thus far with
iO-Flex are helping position Baxano for significant growth in 2013 and
beyond as the healthcare environment evolves. Since being founded,
Baxano has been resolute in providing patients and physicians better
solutions for spine surgery."
Baxano's iO-Flex System is the first minimally invasive set of flexible
instruments allowing surgeons to target lumbar stenosis in the central
canal, lateral recess, and neural foramen with minimal disruption to the
patient's healthy anatomy critical for maintaining spinal stability.
Lumbar spinal stenosis is a degenerative medical condition in which the
spinal canal narrows and compresses the spinal cord and nerves in the
lumbar area of the spine. Symptoms include pain, weakness, numbness, and
tingling in the lower back and legs.
Decompression surgery is a common procedure used to treat lumbar spinal
stenosis by cutting away overgrown bone and tissue causing pressure on
the spinal nerves. Approximately 325,000 decompression procedures are
performed in the United States each year to treat lumbar spinal
stenosis. Baxano's iO-Flex System is the first and only treatment
alternative that allows surgeons to decompress up to four nerve roots
through a single laminotomy and preserve the integrity of the facet
joints to maintain spinal stability.
About Baxano, Inc.
Baxano, Inc., based in San Jose, California, is a privately held
company, which was founded in 2005 with the vision to create flexible
tools to provide precision lumbar decompression from the "inside out."
These platform technologies will form the basis for future product
offerings. Baxano's mission is to develop innovative tools that restore
spine function, preserve healthy tissue, and enable a better quality of
life for patients. Along with its dedication to advanced technology
development, Baxano is focused on providing exceptional value to
patients, customers, investors, and employees.
Caution: Federal law restricts this device to sale by or on the order of
For complete information regarding Intended/Indications for Use,
Precautions, Warnings, and potential adverse events, please refer to
respective Instructions for Use.
For more information about Baxano, the iO-Flex System, or the company's
post-market clinical studies, please visit: www.baxano.com
or contact media relations representative Paul Williams at 310/569-0023
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