Clinical Research

Baxano, Inc. is dedicated to the development, implementation and reporting of various clinical research activities. The goals of the Clinical Affairs team include:

• Promotion and advancement of our FDA 510(k) cleared surgical technology using Good Clinical Practices
• Report our clinical findings in peer-reviewed literature
• Enhance our professional medical education efforts

Clinical support to date includes:

• Pre-clinical validation of the Neuro Check® device
• Cadaver CT analysis comparing the iO-Flex® System and standard microdecompression
• Prospective and retrospective U.S. clinical studies of the iO-Flex® System in patients with lumbar spinal stenosis

Open Clinical Studies:

	CP-1318: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
Purpose	To show the iO-Flex® System is a safe and effective method for treating patients with lumbar spinal stenosis
Design	Single arm, 1 or 2 levels of stenosis with neuroforaminal involvement
Key Inclusion Criteria	Leg/buttock pain with or without back pain Leg pain on Visual Analog Scale (VAS) is at least 4 points Spinal stenosis at up to 2 levels from L2-S1
Key Exclusion Criteria	Central stenosis only, back pain only Scoliosis with a Cobb angle ≥ 25°

Additional information can be found at www.clinicaltrials.gov

	CP-1967: Spondylolisthesis Treated with an iO-Flex® System Enabled Decompression
Purpose	To evaluate comprehensive performance of iO-Flex® System in treating patients with stable grade I degenerative spondylolisthesis and radicular symptoms secondary to trans-foraminal lumbar stenosis compared to objective performance criteria established by current standard of care
Design	Single arm, stable grade 1 spondy with 1 adjacent level of stenosis
Key Inclusion Criteria	Leg/buttock pain with or without back pain Grade 1 degenerative spondylolisthesis NRS pain score for let pain of 4/10 or greater Treatment at adjacent levels
Key Exclusion Criteria	Fixed motor deficit Instability of lumbar spine defined as > 4mm translation Prior surgery of lumbar spine Vascular claudication in the lower extremities

Additional information can be found at www.clinicaltrials.gov