Epineuron's PeriPulse System Receives Health Canada Approval for Nerve Regeneration
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Epineuron (search) has received Health Canada approval for its PeriPulse (search)™ system, designed to enhance nerve regeneration (search) in patients with severe nerve injuries (search) and chronic neurological conditions (search).
The PeriPulse (search)™ system features an advanced shapeable electrode and a patient-wearable component, facilitating quick deployment and electrical stimulation therapy in the recovery room.
Clinical data supporting the approval comes from a multi-center first-in-human trial, with further data expected from ongoing REGAIN™ and SELECT™ trials focused on nerve lacerations (search) and compression injuries (search).
Epineuron (search) has announced that its PeriPulse (search)™ system has been approved by Health Canada for nerve regeneration (search). This approval allows Canadian surgeons to access a therapeutic solution aimed at improving nerve regeneration for patients suffering from severe nerve injuries (search) and chronic neurological conditions (search).
The PeriPulse (search)™ system is designed to deliver electrical stimulation therapy to damaged nerves. The system includes a shapeable electrode that can be quickly deployed during surgery and a wearable component for patient use. This setup allows for the delivery of one-hour electrical stimulation therapy in the recovery room, significantly reducing the time spent in the operating room—reportedly by about 95%.
According to Sergio Aguirre, CEO and co-founder of Epineuron (search), this approval marks a pivotal moment for the company and represents a major technological breakthrough with the potential to dramatically improve patients' lives. Dr. Tessa Gordon, a neuroscientist and Professor Emeritus at the Universities of Alberta and Toronto, added that this product has the possibility to fit the broadest set of surgical applications in peripheral nerve.
Epineuron (search) is currently expanding its clinical data through two ongoing trials: REGAIN™, which focuses on nerve lacerations (search), and SELECT™, which is investigating compression injuries (search). The company is now scaling up its manufacturing, sales, and marketing operations to support the commercial launch of the PeriPulse (search)™ system.