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

Evolution in intraoperative nerve identification and evaluation.

MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Epineuron, a medical device company pioneering bioelectronic medicine, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala® Nerve Stimulator. This handheld, intraoperative electrical stimulation device is engineered to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, large and small. This milestone marks a significant expansion of the company’s portfolio and commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.

Dr. Jana Dengler, MD, MASc, MHSc, a peripheral nerve surgeon at the renowned Sunnybrook Health Sciences Centre in Toronto, ON, was among the early users of Evala®. “I am impressed with the versatility of the product allowing me to evaluate nerves in scarred revision surgeries, nerve transfers, under extended tourniquet time, and in conjunction with PeriPulse,” said Dr. Dengler.

"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. "We’ve broadened our technology by complementing PeriPulse® with Evala® to support surgeons during the most demanding aspects of a procedure. Whether it’s protecting nerves in real-time or boosting their regenerative capacity afterward, our technology integrates seamlessly into the surgical workflow to enhance efficiency and offer patients the best path to recovery. "

The expansion of Epineuron’s portfolio reflects its dedication to delivering transformative bioelectronic advancements to the field of peripheral nerve care, highlighting the company’s enduring promise to clinicians and the patients they serve.

For more information, visit www.epineurontech.com.

About Epineuron

Epineuron Technologies Inc. is a commercial-stage medical device company dedicated to restoring function through our proprietary bioelectronic solutions for nerve evaluation and regeneration. Headquartered in Mississauga, ON, our mission is to empower clinicians and improve patient quality of life by providing simple, intuitive, and effective bioelectronic solutions that streamline decision-making and unlock the therapeutic potential of the peripheral nervous system.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260513096941/en/

Dr. Mike Willand, PhD, PEng
[email protected]

Source: Epineuron Technologies Inc.

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