Epineuron Technologies, a Canada-based clinical-stage nerve care company developing a bioelectronic therapy for the treatment of injured peripheral nerves, announced on May 12 that it has received 510(k) clearance of its Evala® Nerve Stimulator from the U.S. Food and Drug Administration (FDA).
The Evala device is a handheld, single-use intraoperative electrical stimulator designed to help surgeons locate nerves and evaluate their function. According to Epineuron’s website, the device’s ability to evaluate both large and small nerves in real time provides versatility, allowing a single device to be used across multiple surgical applications.
Paired with Epineuron’s PeriPulse® nerve stimulation system, which was approved by Health Canada in September 2024 and designated as a Breakthrough Device by the U.S. FDA, Epineuron aims to support clinicians across the surgical continuum, from intraoperative nerve protection to post-operative regeneration.
The PeriPulse nerve stimulation system is a temporary wearable system with a shapeable electrode that delivers proprietary bioelectronic therapy for nerve regeneration and is currently approved for investigational use in the U.S. The REGAIN™ clinical trial for the PeriPulse nerve stimulation system is ongoing in various locations across the US and Canada, with an estimated completion date of September 2026.
Epineuron’s CEO, Sergio Aguirre, stated in the press release for the 510(k) clearance: “At Epineuron, we’ve listened closely to surgeons that expressed a significant need for more than just nerve stimulation hardware, they needed a cohesive ecosystem for nerve care.”
Tags
510(k) Clearance, Epineuron, FDA Clearance, Health Canada, Medtech, Neurostimulators, REGAIN
