Empirical Spine Advances LimiFlex™ as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
2021 Brought Breakthrough Device Designation and PMA Process Initiation
San Carlos, Calif. (February 1, 2022) – 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. The company also recently initiated several key pre-commercial/market readiness projects.
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. The FDA's Breakthrough Devices Program accelerates the development of medical devices with the potential to effectively treat or diagnose life-threatening or irreversibly debilitating diseases. 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 2022 PFS are now 32.11, a 14% increase from the previous total RVUs of 28.28. The initiative for the update was led by the International Society for the Advancement of Spine Surgery (ISASS), with support and participation from other spine surgery societies and Empirical Spine.
LimiFlex Study Data Presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum. In November, 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 we made in 2021 and enter the final run up leading to market.”
Currently, an estimated 140,000 patients receive lumbar fusion annually for degenerative spondylolisthesis in the US alone. Despite reported results superior to standalone decompression, instrumented fusion remains an invasive surgical option not appropriate or desirable for many patients due to its longer recovery time and postoperative complications. Post-fusion rates of adjacent segment degeneration, just one important sequela that can lead to additional fusion surgery, range from 30-50% in the literature.
LimiFlex received the CE mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including 10-years' experience with the device in Europe, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution for this large patient population.
About LimiFlex
The LimiFlex™ is the first-in-class Dynamic Sagittal Tether (DST) and is designed to maintain motion and stability after an open spinal decompression, without contributing to adjacent level issues for grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. By augmenting the posterior band, LimiFlex creates elastic resistance to flexion and maintains lordosis. For the first time, patients and surgeons will have a minimally invasive option that relieves compressive pain without compromising segmental motion. LimiFlex can be performed in an outpatient setting, typically in less than 20 minutes. LimiFlex does not involve any screws or bone grafts, which can cause issues by eliminating the natural motion between spine segments.
About Empirical Spine
Empirical Spine, Inc., founded in 2015, is a privately held company creating a new standard in spine surgery that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life. The company is currently running a pivotal IDE trial in the US on its breakthrough LimiFlex Dynamic Sagittal Tether. LimiFlex is a minimally invasive implant designed to stabilize the spine after open decompression, while preserving motion.
Caution: The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.