Empirical Spine closed a Series B financing of $10 million. Funds will advance the commercialization of the LimiFlex Paraspinous Tension Band, including completion of the ongoing pivotal trial and submitting all components of a premarket approval filing to FDA.
LimiFlex was developed to offer a minimally invasive means to stabilize the spine yet preserve motion.
The prospective, multicenter, controlled clinical trial is comparing LimiFlex Paraspinous Tension to transforaminal lumbar interbody fusion in the treatment of degenerative spondylolisthesis and lumbar spinal stenosis.
LimiFlex received approval under the CE Mark in 2009 and has been implanted in over 2,000 European patients.
"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."