Thursday, August 31, 2023
Epineuron, a clinical-stage company specializing in nerve care, has made an exciting announcement regarding its REGAIN™ program. The company has achieved a significant milestone by successfully enrolling the inaugural participant in a pivotal trial that bears the same name. This trial, characterized by its multicenter, randomized, sham-controlled, and double-blinded design, aims to assess the safety and efficacy of an investigational technology known as PeriPulse™. Notably, PeriPulse™ has received FDA Breakthrough Device designation and is intended for treating peripheral nerve injuries.
The trial is set to be conducted across medical centers in both Canada and the United States, with an ambitious goal of enrolling up to 110 patients. If successful, this trial will mark one of the largest explorations of nerve regeneration utilizing a medical device. What sets this technology apart is its thoughtful engineering, which emphasizes user-friendliness and minimal disruption to established surgical procedures. Surgeons will have the unique ability to apply stimulation post-surgery, even in the recovery room, a crucial advancement in the journey toward introducing the first therapeutic solution for enhancing recovery from peripheral nerve injuries to the market.
For Epineuron, enrolling the first patient signifies a significant achievement. Witnessing the translation of cutting-edge scientific advancements from theory to practical patient care is both remarkable and promising. REGAIN™, as a pivotal trial conducted across multiple centers, is poised to advance our knowledge of treating traumatic nerve injuries. With its prospective, double-blinded, randomized, and sham-controlled structure, the trial holds the potential to reshape our approach to nerve injury treatments.
Source: businesswire.com
