MISSISSAUGA, Ontario--(BUSINESS WIRE)--Epineuron, a clinical-stage nerve care company, announced it has successfully enrolled the first patient in the company’s pivotal trial, REGAIN™. The multicenter, randomized, sham-controlled, double-blinded study is evaluating the safety and effectiveness of PeriPulse™, an investigational technology designated an FDA Breakthrough Device for the treatment of injured peripheral nerves. The study aims to enroll up to 110 patients across Canada and the United States of America, making it the largest medical device study for nerve regeneration.
PeriPulse™ is a direct clinical translation of the pioneering research led by Drs. Tessa Gordon and Ming Chan from the University of Alberta spanning basic science to early clinical studies investigating the effects of bioelectronic therapy combined with standard nerve interventions. The proprietary system has been engineered to enhance usability and minimize disruption to regular surgical workflows by affording surgeons the ability to apply stimulation after the procedure, in the recovery room.
The first patient enrolled in REGAIN™ was treated by Dr. Adil Ladak, a former Master’s student of Tessa’s from the University of Alberta, creating a remarkable full-circle moment in the journey towards advancing the commercialization of the first therapeutic solution to improve recovery of peripheral nerve injuries.
Dr. Ming Chan, MD, commented, “The first patient enrollment is an exciting milestone for Epineuron and witnessing the translation of scientific advancement from bench to bedside is truly remarkable. Our study team is eager to see the progress of the trial as it unfolds.”
“We are thrilled to see the REGAIN™ study come to fruition with the dedication of our entire team. We are committed to forging the path for a better standard of care-for the treatment of injured peripheral nerves,” said Sergio Aguirre, CEO, and cofounder of Epineuron.
Epineuron is a clinical-stage nerve care company developing a novel class of bioelectronic therapy that offers a transformative approach to aid in the treatment of injured peripheral nerves. With innovation and collaboration their team strives to redefine the standard of care for peripheral nerve treatment and improve patient outcomes. For more information, visit www.epineurontech.com.
REGAIN™ is a multicenter pivotal trial designed to evaluate the safety and effectiveness of PeriPulse™ in treating traumatic injuries. The study is prospective, double-blinded, randomized, and sham-controlled.