BOSTON, MA and PROVIDENCE, RI, Jan. 12, 2026 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neurotechnology company developing a breakthrough non-invasive approach for treating Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig’s disease), today announced completion of its ALS Early Feasibility Study (EFS) evaluating the MyoRegulator® device as a non-invasive treatment for people with ALS.
ALS is a progressive neurodegenerative disorder that affects motor neurons in the brain and spinal cord, leading to muscle weakness, paralysis, spasticity, and ultimately death, typically within two to five years of diagnosis. The MyoRegulator® device, which recently received FDA “Breakthrough Device Designation” for the treatment of ALS, utilizes PathMaker’s proprietary multi-site direct current stimulation (Multi-Site DCS) technology to deliver non-invasive therapy designed to reduce motor neuron hyperexcitability and activate protein degradation pathways.
The ALS EFS, supported by funding from the Muscular Dystrophy Association’s (MDA) MVP program, successfully enrolled and treated five study participants at Spaulding Rehabilitation Hospital (SRH) in Charlestown, Massachusetts. PathMaker Neurosystems will be presenting top-line results from this study in an invited oral presentation at the 2026 MDA Clinical & Scientific Conference (March 8-11, 2026).
“We are grateful to have had the support of MDA to complete this important first-in-human study of our MyoRegulator® device in people with ALS, and extend our deepest thanks to the study participants, their families and the dedicated team at SRH for making this possible,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and Chief Executive Officer of PathMaker Neurosystems. “The encouraging early findings that we will be presenting soon pave the way for expanded clinical investigations, bringing us closer to delivering a much-needed therapeutic option for the ALS community that can be administered in the home-use setting.”
Currently, the MyoRegulator® device is under investigation as a non-invasive treatment for ALS in a second and larger clinical trial, the CALM (Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability) study (NCT06649955), supported by the U.S. Department of War ALSRP program, and currently enrolling.
About PathMaker Neurosystems Inc.
PathMaker Neurosystems is a clinical-stage neurotechnology company developing a breakthrough non-invasive approach to the treatment of amyotrophic lateral sclerosis (ALS). More than 34,000 people in the U.S. and 350,000 people worldwide are estimated to suffer from ALS. PathMaker is collaborating with world-class institutions to develop and bring to market first-in-class products for treating ALS and other neurological disorders with very high unmet medical need. The MyoRegulator® platform is based on PathMaker’s proprietary technology for multi-site direct current stimulation (Multi-Site DCS). MyoRegulator® has received “FDA Breakthrough Device Designation” for the treatment of ALS from the US Food and Drug Administration (FDA). MyoRegulator® and MyoRegulator® ALS are investigational medical devices and are limited by Federal law to investigational use only. For more information, please visit the company website at www.pmneuro.com.
Source: PathMaker Neurosystems Inc.
Media contact: PathMaker PR
(617) 693-7555
partnering@pmneuro.com
