Ontario Neurotech Company Epineuron Receives FDA 510(k) Clearance for Evala® Nerve Stimulator

14 mai 2026

An OBI portfolio company advances the frontier of intraoperative peripheral nerve care

The Ontario Brain Institute (OBI) congratulates Epineuron Technologies Inc. on receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for its Evala® Nerve Stimulator. The clearance marks a significant regulatory milestone for the Mississauga-based bioelectronic medicine company and a proud moment for Ontario's neurotechnology ecosystem.

The Evala® is a handheld, intraoperative electrical stimulation device engineered to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, large and small. It expands Epineuron's commercial portfolio alongside its existing PeriPulse® device, further building out the company's bioelectronic platform for nerve health.

Dr. Jana Dengler, a peripheral nerve surgeon at Sunnybrook Health Sciences Centre in Toronto, was among the first clinicians to use the device, highlighting its versatility across complex surgical scenarios including scarred revision surgeries and nerve transfers.

"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," said Sergio Aguirre, CEO of Epineuron. "Whether it's protecting nerves in real-time or boosting their regenerative capacity afterward, our technology integrates seamlessly into the surgical workflow."

Ontario Grown Neurotech Innovation

Epineuron's path to FDA clearance reflects what Ontario's neurotech sector can produce. The company joined OBI's portfolio in 2017 through the Ontrepreneur program, an early-stage neurotech support initiative that has since evolved into NERVE (Neurotech Entrepreneurship to Validate Emerging Innovations) — Canada's largest neurotech award program. Through NERVE, OBI continues to identify and accelerate promising companies developing solutions for neurological conditions, providing funding, mentorship, and access to a world-class research and clinical network.

Epineuron's growth from an early-stage Ontario startup to a commercially active medical device company is the translational impact NERVE is designed to enable.

For more information about Epineuron, visit www.epineurontech.com.

More about the OBI's NERVE Program