LimiFlex Paraspinous Tension Band on track for PMA Submission
San Carlos, Calif. – May 27, 2021 – Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. SHD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members. The funds will be used to advance the product on its path to market, including completing the ongoing pivotal trial and submitting all components of the PMA filing to the FDA.
“We are gratified by the confidence investors are showing in the LimiFlex device,” said Empirical Spine CEO Richard Treadwell. “As study data accumulates, we have more and more evidence that LimiFlex is on track to meet or exceed the clinical results we hoped for. The new funds will enable us to develop and submit a very strong PMA filing in the coming months.”
Dr. Reginald Davis of BioSpine Institute commented, “Results from the LimiFlex trial suggest the LimiFlex device may offer a motion-preserving, minimally invasive treatment option suitable for use in outpatient settings, such as the ambulatory surgery center (ASC). In my practice, I have seen increased interest in these benefits from both patients and physicians.”
Traditional means of stabilizing the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together. The LimiFlex was developed to offer a minimally invasive way to stabilize the spine yet preserve motion. The device aims to restore the spine’s natural biomechanics, with respect to parameters such as stiffness, lordosis, and facet engagement.
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 transforaminal lumbar interbody fusion (TLIF) in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis. The study primary endpoint is a comparison of success of a composite endpoint, including improvement in pain and function and absence of adverse sequelae, at 24 months. The objective of the study is to demonstrate that patients can achieve the benefits of spinal stabilization, without the complications related to fusion of vertebrae.
The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients.
The LimiFlex Paraspinous Tension Band is a new, investigational device designed to be an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. LimiFlex does not involve any screws or bone grafts, which eliminate 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.
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.
SOURCE: Empirical Spine