Baxano Receives CE Mark for iO-Flex® System

SAN JOSE, Calif.–(BUSINESS WIRE)–Baxano, Inc., a Silicon Valley-based medical device company and manufacturer of the iO-Flex® System for spinal decompression surgery, announced today that it has received CE Mark approval allowing for future expansion into European markets.

“This is a major milestone for the company”

Already FDA cleared, Baxano’s flagship iO-Flex System has rapidly gained interest among US spine and neurosurgeons as the first minimally invasive set of flexible instruments designed 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. It is the only treatment alternative that allows surgeons to decompress up to four nerve roots through a single laminotomy.

“This is a major milestone for the company,” said Tony Recupero, President & CEO of Baxano. “Although our immediate focus remains supporting our domestic sales demand, we look forward to working with our international surgeon partners and being able to provide their patients suffering from lumbar spinal stenosis a new minimally invasive surgical option.”

Preliminary results from a post market clinical study on the iO-Flex System will be presented by neurosurgeon, Lawrence Dickinson, MD, at the upcoming International Society for the Advancement of Spine Surgery held in Barcelona, Spain, March 20-23rd.

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.

For more information about Baxano, the iO-Flex System or the company’s post-market clinical trials, please visit: www.baxano.com or contact media relations representative Paul Williams at 310-569-0023 or paul@medialinecommunications.com.

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 a physician. 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 and its products, please visit: www.baxano.com


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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