Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

SAN CARLOS, Calif., February 25, 2021 (Newswire.com) - ​Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery.

The trial previously exceeded its target of 135 LimiFlex patients enrolled into the investigational arm and 160 patients enrolled into the control arm of the trial.

"With trial enrollment fully achieved in 2020, our regulatory effort is now accelerating into the PMAsubmission phase," explained Richard Treadwell, Empirical Spine's CEO. "The FDA's acceptance of the PMA Shell is an important step towards submitting all three PMA modules, which we expect to accomplish by the end of 2021."

Co-principal investigator Rick Sasso, MD, of the Indiana Spine Group commented, "My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilize the spine yet preserve motion. LimiFlex also represents a new alternative as an outpatient procedure, with 2/3 of LimiFlex patients discharged the same day and almost half treated in ASC settings." William Welch, MD of the University of Pennsylvania and co-principal investigator of the LimiFlexIDE study added, "I am encouraged by the clinical outcomes and results we have seen so far in the study. LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant savings for payors, and more surgical offerings for spine surgeons."

The LimiFlex IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the LimiFlex Paraspinous Tension Band compared to TLIF in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis. The study endpoint is the rate of overall clinical success at 24 months. Currently, over 200 patients have reached 12 months follow-up and more than 100 patients have achieved the 24-month primary endpoint. The goal is to show that patients can achieve fusion-equivalent results - without the fusion.

The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients.

About LimiFlex

The LimiFlex Paraspinous Tension Band is a new, investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. Unlike the standard of care, lumbar spinal fusion, LimiFlex does not involve any screws or bone grafts, which disrupt the natural motion between spine segments.

Instead, LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion. The device works by supporting and enhancing the spine's natural biomechanics with stabilizing yet flexible elements. The LimiFlex device is placed following a standard decompression surgery, typically in less than 20 minutes. The less invasive nature of the procedure also offers promise as an outpatient or ambulatory surgery, providing significant flexibility to patients and their surgeons, as well as the potential for significant cost savings compared to inpatient fusion surgery.

About Empirical Spine

Empirical Spine, Inc. is a privately held company developing advanced solutions for the surgical treatment of spinal disorders. The company is currently running a pivotal IDE trial in the US on its motion-preserving Paraspinous Tension Band, LimiFlex. LimiFlex is a minimally invasive implant that is designed to stabilize the spine after decompression surgery yet preserve motion.

Caution: The LimiFlex Paraspinous Tension Band is an investigational device in the United States and is limited by law to investigational use.

Contact: Empirical Spine | PO Box 885 San Carlos, CA 94070 | 650-585-6307