Epineuron Reveals Topline Pilot Study Results in Bioelectronic Medicine, Highlighting PeriPulse® System’s Potential to Accelerate Nerve Regeneration

A pivotal first-in-human trial has demonstrated the efficacy of the PeriPulse® Nerve Stimulation System, a novel wearable temporary nerve stimulator designed to enhance electrical stimulation therapy for the regeneration of acutely injured peripheral nerves. Featured in the journal Bioelectronic Medicine, the study revealed that 87.5% of the patients who received treatment exhibited significant and lasting improvements in sensation six months post-injury compared to their condition before surgery, indicating the potential of this technology to facilitate substantial functional recovery.

Addressing peripheral nerve injuries remains a formidable challenge, especially in acute trauma situations where surgery is typically the standard treatment. However, surgical procedures often lead to slow and incomplete recoveries, placing a heavy burden on both patients and healthcare systems. The PeriPulse® system, developed by Epineuron, offers an innovative approach that streamlines the treatment process and can enhance patient outcomes without extending operating room times. Dr. Mike Willand, the Co-Founder and CTO of Epineuron, emphasized the significance of this study, which not only validates their vision for advancing nerve regeneration but also indicates a promising shift in how nerve injuries may be treated in the future.

The trial further illustrated the system's safety and high patient tolerance, bolstering its potential for widespread use in clinical settings. It offers renewed hope for patients suffering from nerve injuries and provides surgeons with an effective tool to deliver necessary treatments. Currently, the findings are paving the way for the REGAIN™ trial, which stands as the largest multinational medical device study focused on nerve regeneration, spanning Canada and the U.S. This trial aims to support Epineuron's application for FDA approval of the PeriPulse® device.

Dr. James Bain, a Professor of Plastic Surgery at McMaster University and the study's corresponding author, expressed that improved nerve regeneration is transformative for patients. He noted that the PeriPulse® system allows for efficient delivery of electrical stimulation therapy without disrupting the surgical workflow, providing promising prospects for significantly enhancing outcomes for those with peripheral nerve injuries.

Epineuron is dedicated to progressing bioelectronic solutions for nerve damage repair and treatment. The PeriPulse® technology, already approved by Health Canada and designated as an FDA Breakthrough Device, employs electrical stimulation to hasten the recovery process of injured peripheral nerves, integrating seamlessly into the perioperative workflow.

In summary, the findings from this groundbreaking trial not only highlight the potential benefits of the PeriPulse® system in treating peripheral nerve injuries but also signal a transformative approach to nerve regeneration, offering hope for improved patient recovery and surgical efficiency. The ongoing REGAIN™ trial further reinforces the commitment to validating this innovative solution in clinical settings.