TORONTO--(BUSINESS WIRE)--Epineuron is excited to announce Health Canada approval of its innovative nerve regeneration system, the PeriPulse™. Building on the success of its multi-center first in-human clinical trial, surgeons in Canada now have access to the only therapeutic solution designed to enhance nerve regeneration, providing best-in-class care for patients with severe nerve injuries and chronic neurological conditions.
“Our team is incredibly proud to reach this pivotal moment,” said Sergio Aguirre, CEO and co-founder of Epineuron. “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, PhD, 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.
For additional information about Epineuron visit www.epineurontech.com.
About Epineuron
Epineuron, a nerve care company, is dedicated to advancing bioelectronic solutions for the repair and treatment of damaged nerves. Its flagship technology, the PeriPulse™, uses electrical stimulation to harness the regenerative potential of peripheral nerves and accelerate their recovery after injury. The Health Canada approved and FDA designated breakthrough device offers surgeons a seamless clinical workflow by enabling perioperative nerve stimulation in the recovery room.
