First U.S. commercial cases establish LimiFlex as an outpatient, motion-preserving stabilization option
SAN CARLOS, CA / ACCESS Newswire / May 19, 2026 / Empirical Spine announces the U.S. market introduction of the LimiFlex Dynamic Sagittal Tether, an outpatient, motion-preserving alternative to spinal fusion following decompression. Todd Alamin, MD, Empirical Spine Co-founder, successfully performed the first two commercial implantations of the Class III dynamic stabilization device designed to treat Grade I lumbar degenerative spondylolisthesis with stenosis1, at Stanford Medicine on April 30, 2026.
After the cases, Dr. Alamin shared, "Being in the OR for the first commercial LimiFlex cases was a defining moment after more than two decades of development. We are one step closer to bringing this technology to surgeons and patients across the U.S. who have been waiting for a motion-preserving alternative to fusion."
The company received U.S. Food & Drug Administration (FDA) Premarket Approval (PMA) for LimiFlex on February 12, 2026. In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared to instrumented spinal fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in indicated patients. LimiFlex patients also demonstrated faster return to work and activities of daily living, improved disability scores (Oswestry Disability Index, ODI), and durable improvements in leg and back pain along with a numerically lower but statistically similar reoperation rate.
"This marks an important milestone for patients with lumbar degenerative spondylolisthesis who have failed conservative treatment," said Louie Fielding, Co-Founder and President of Empirical Spine, "LimiFlex offers a motion-preserving, outpatient option that allows us to treat many of these patients without defaulting to fusion."
The company has initiated a limited U.S. market release, beginning with centers that participated in the LimiFlex IDE trial, with broader commercial expansion planned throughout 2026.
For more information, please visit LimiFlex.com.
About Empirical Spine
Empirical Spine, Inc. is a medical technology company focused on developing surgical solutions that align the magnitude of treatment with the magnitude of disease. The company's technologies are designed to address structural spine conditions using motion-preserving approaches intended to reduce the physiologic burden of traditional surgical constructs. Learn more at LimiFlex.com.
Contact
Louie Fielding
Co-founder, President & COO
info@empiricalspine.com
650-585-6307
1 The LimiFlex Dynamic Sagittal Tether is a motion-preserving spinal implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression. The LimiFlex Dynamic Sagittal Tether is indicated for use at one level from L3-L5, in skeletally mature patients following surgical decompression for treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification in a lateral radiograph) with spinal stenosis. Patients consist of those with neurogenic claudication or radiculopathic symptoms, including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, who have been unresponsive for a minimum of three months of non-operative treatment and have a confirmed diagnosis through patient history and diagnostic studies using X-ray, MRI and/or CT.
SOURCE: Empirical Spine
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View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/empirical-spine-announces-first-commercial-limiflexr-cases-at-stanfor-1168020
