Pathmaker Neurosystems Announces IRB Approval For Dod-Funded Clinical Trial Of The Myoregulator Device In ALS

BOSTON, Feb. 04, 2025 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neuromodulation company developing a breakthrough non-invasive approach to the treatment of ALS, announced today that it has received Institutional Review Board (IRB) approval to begin enrollments in the U.S. Department of Defense-funded CALM study,“Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability”. This clinical trial of PathMaker's MyoRegulator^® investigational device in individuals with ALS will be conducted at Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA, where it is being led by Seward Rutkove, M.D., Chair, Department of Neurology at Beth Israel Deaconess Medical Center and Nancy Lurie Marks Professor of Neurology at Harvard Medical School; and Courtney McIlduff, M.D., MMSc, Assistant Professor of Neurology at Harvard Medical School and Director of the Multi-Disciplinary ALS Clinic at Beth Israel Deaconess Medical Center. The CALM study (NCT06649955) is a single-site, open-label trial to further evaluate the feasibility and safety of MyoRegulator^® treatment in individuals with ALS and to provide initial evidence of efficacy through state-of-the-art clinical, neurophysiological and biochemical endpoints.

PathMaker's approach is based on the company's proprietary multi-site direct current stimulation (Multi-Site DCS) platform, which modulates neurons and circuits associated with ALS through the suppression of motor neuron hyperexcitability and activation of protein degradation pathways. The MyoRegulator^® device has already been investigated in one early feasibility trial for ALS and three clinical trials for post-stroke spasticity.

Nader Yaghoubi, M.D., Ph.D., PathMaker's Co-Founder and CEO, stated,“We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms by which our technology work, we believe our non-invasive platform represents a new treatment modality that will be broadly applicable to ALS.”

This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Amyotrophic Lateral Sclerosis Research Program under Award No. HT94252410407. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

About PathMaker Neurosystems Inc.

PathMaker Neurosystems is a clinical-stage neuromodulation company developing a breakthrough non-invasive approach to the treatment of amyotrophic lateral sclerosis (ALS). From its headquarters in Boston, 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. More than 30,000 people in the U.S. suffer from ALS, with an additional 6,000 new ALS diagnoses each year in the U.S.

The MyoRegulator^® platform is based on PathMaker's proprietary technology for multi-site direct current stimulation (Multi-Site DCS). MyoRegulator® has been previously designated by the US Food and Drug Administration (FDA) as a“FDA Breakthrough Device.” 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 .

Source: PathMaker Neurosystems Inc.
Media contact: PathMaker PR
(617) 535-7696
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