17 December 2025

PathMaker Neurosystems, a clinical-stage neurotechnology company developing a breakthrough non-invasive approach for treating ALS, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for use of the MyoRegulator^® device as a non-invasive, neuromodulatory intervention for slowing the progression of functional symptoms in people with ALS.

FDA Breakthrough Device Designation accelerates the development, assessment, and review of medical devices that may provide an effective treatment or diagnosis alternative for life-threatening or debilitating diseases, and provides companies selected for Breakthrough Designation with prioritized review and expedited opportunities to interact with FDA experts throughout the review period.

The MyoRegulator^® device uses PathMaker’s proprietary multi-site direct current stimulation (Multi-Site DCS) technology to provide non-invasive treatment that is designed to suppress motor neuron hyperexcitability and activate protein degradation pathways. “We are very pleased and honored to see Breakthrough Device Designation on the MyoRegulator^® device for ALS. This designation further validates our pioneering approach to ALS, as well as the tremendous unmet medical needs of people and families living with ALS,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and Chief Executive Officer of PathMaker Neurosystems. “The Breakthrough Device Designation represents a significant de-risking and accelerates our path to market for this treatment.”

The MyoRegulator^® device is currently under investigation as a non-invasive treatment for ALS in its second clinical trial, the CALM (Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability) study (NCT06649955). Funded by the U.S. Department of War ALSRP program, this state-of-the-art trial represents an important step forward in advancing this novel therapeutic modality into clinical practice.

Source: PathMaker Neurosystems Inc.