PathMaker's non-invasive stimulation device gets FDA Breakthrough designation for ALS
MyoRegulator uses multi-site direct current stimulation aimed at slowing the loss of function in ALS.
PathMaker Neurosystems has received FDA Breakthrough Device designation for MyoRegulator in ALS. The non-invasive device delivers direct current stimulation at several sites. It is designed to calm overexcited motor neurons and, the company says, activate pathways that clear damaged proteins, with the goal of slowing functional decline. In January 2026 the company reported completing an early feasibility study.
Breakthrough designation speeds FDA interaction but isn’t approval, and efficacy in ALS still has to be shown.
Learn more: ALS · Breakthrough Device designation