OEM News, Regulatory

Health Canada Approval Granted to Epineuron’s PeriPulse System

PeriPulse uses an advanced shapeable electrode and a patient wearable, allowing for quick deployment at the end of surgery.

By: Michael Barbella

Managing Editor

Epineuron has won Health Canada approval for PeriPulse, a nerve regeneration system.

Building on the success of its multi-center first in-human clinical trial, Canadian surgeons now have access to the only therapeutic solution designed to enhance nerve regeneration for patients with severe nerve injuries and chronic neurological conditions.
 
“Our team is incredibly proud to reach this moment,” Epineuron Co-Founder/CEO Sergio Aguirre said. “The approval is a testament to the hard work and dedication of our researchers, clinicians, and partners. This device not only represents a major technological breakthrough but also holds the promise of dramatically improving the lives of patients.”
 
The PeriPulse nerve stimulation system uses an advanced shapeable electrode and a patient wearable, allowing for quick deployment at the end of surgery. This enables delivery of the well-established one hour electrical stimulation therapy in the recovery room, cutting time spent in the operating room by about 95%.
 
“I am delighted to see the translation of my pioneering work on regenerative electrical stimulation into a product that has the possibility to fit the broadest set of surgical applications in peripheral nerve,” said Dr. Tessa Gordon, Ph.D., a neuroscientist and Professor Emeritus at the Universities of Alberta and of Toronto.
 
Epineuron continues to expand its clinical data through two ongoing trials, REGAIN and SELECT, focused on nerve lacerations and compression injuries, respectively. With the regulatory approval secured, the company is expanding its operations to boost manufacturing, sales, and marketing, to support commercialization.
 
A nerve care company, Epineuron advances bioelectronic solutions to repair and treat damaged nerves. Its flagship technology, the PeriPulse, uses electrical stimulation to harness the regenerative potential of peripheral nerves and accelerate their recovery after injury. 

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