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 facetectomies.

"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 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, 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 or paul@medialinecommunications.com.