LimiFlex™ – Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US.
LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis, designed to restore natural segmental motion and stability after an open lumbar decompression by augmenting the posterior tension band.
This creates elastic resistance to flexion and maintains lordosis. The Dynamic Sagittal Tether is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks including being highly invasive, increasing risk of long-term sequelae, and high costs.
LimiFlex Progress in 2021
- Breakthrough Device Designation (BDD). The US Food & Drug Administration (FDA) granted BDD for LimiFlex, determining it holds the potential to offer significant advantages over existing approved or cleared treatment alternatives.
Key potential benefits cited in the BDD application include less invasive and shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospital stay, and improved quality of life, including motion-preservation at the affected spinal level. Empirical Spine already has seen benefits of this status in expedited review timelines and increased communication with the FDA.
- Premarket Approval (PMA) Module 1 (Pre-Clinical Testing) Submitted. LimiFlex’s three-part Modular PMA process with the FDA commenced in 2021. Module 1 was submitted and received encouraging feedback. The remaining modules are being completed and will be submitted in the coming months.
- Increased Physician Reimbursement. As part of the 2022 Medicare Physician Fee Schedule (PFS), Centers for Medicare & Medicaid Services (CMS) reviewed and revised the value for Insertion of Spinal Stabilization devices (CPT 22867). CMS increased the Relative Value Units (RVUs) assigned to CPT 22867 from the previous work RVU of 13.50 to 15.00. The total RVUs for 22867 under the PFS are now 32.11, a 14% increase from the previous total RVUs of 28.28.
- LimiFlex Study Data Presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum. In November, the outcomes from the IDE study of the company’s LimiFlex Dynamic Sagittal Tether were presented at SMISS by Hyun Bae, MD, Professor of Surgery, Dept. of Surgery, Cedars-Sinai Medical Center, Los Angeles, and LimiFlex Study Investigator. The data presented included 246 subjects with a 12-month follow up. Dr. Bae presented study conclusions showing the investigational LimiFlex group demonstrated similar improvement in disability yet 9 weeks faster mean time to return to work (when applicable) and activities of daily living (ADL) compared to the control TLIF group.
“The milestones we achieved last year are advancing Empirical Spine’s mission to improve the quality of life of patients receiving spine surgery, with our first-in-class Dynamic Sagittal Tether,” said Richard Treadwell, President and CEO of Empirical Spine. “LimiFlex has the potential to change the spinal surgery standard for the many patients who fall within our indication by enhancing the natural function of the body. Moreover, LimiFlex offers the potential for significant cost savings compared to inpatient fusion surgery. I expect 2022 to be an exciting year for the company as we leverage the progress made in 2021 and enter the final run up leading to market.”
