Epineuron’s PeriPulse System Shows Promise in Nerve Regeneration Trial

A groundbreaking first-in-human trial has revealed the potential of Epineuron’s PeriPulse Nerve Stimulation System in regenerating acutely injured peripheral nerves.

In a study published in Bioelectronic Medicine, results showed a significant and sustained improvement in sensation, with 87.5% of treated patients demonstrating clinically meaningful gains six months after injury compared to pre-surgery. The results highlight electrical stimulation therapy’s potential to drive substantial functional recovery.

Treating peripheral nerve injuries remains challenging, particularly in acute trauma scenarios. Surgery, the current standard of care, often results in slow and incomplete recovery, creating substantial burdens for patients and healthcare systems. Epineuron’s novel PeriPulse system provides a simple workflow to improve patient outcomes without prolonging operating room time. “This publication is an important milestone for Epineuron and a testament to our vision for the future of improving nerve regeneration. The utility of our efficient approach to deploying therapy was validated and we look forward to helping patients recover following nerve surgery,” Epineuron Co-Founder/Chief Technology Officer Mike Willand, Ph.D., said.

Epineuron’s wearable temporary nerve stimulator demonstrated a high degree of patient tolerance and safety, underscoring its potential for widespread adoption. The findings offer new hope for patients and provides surgeons the prospect of delivering needed treatment. The study results have paved the way for REGAIN, the largest multinational medical device trial for nerve regeneration, currently underway across Canada and the United States, which is designed to support the company’s bid for U.S. Food and Drug Administration (FDA) approval.

“Better nerve regeneration is game changing for patients,” said Dr. James Bain, M.D., professor of Plastic Surgery, McMaster University, and corresponding study author. “The system provides a simple and effective way to deliver electrical stimulation therapy that does not impact my workflow and prolong my surgeries. This system and approach have the potential to significantly improve outcomes for patients with peripheral nerve injuries.”

Epineuron is a nerve care company advancing bioelectronic solutions for repairing and treating damaged nerves. Its flagship technology, PeriPulse, is Health Canada approved and designated an FDA Breakthrough Device. It uses electrical stimulation to accelerate the recovery of injured peripheral nerves with a seamless perioperative workflow.