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Tell us about your company, the problem you’re solving, and who benefits from your work. Why is it important?
PathMaker Neurosystems is a clinical-stage neuromodulation company developing non-invasive devices designed to calm overactive nerve cells and help clear harmful protein buildup associated with neurodegenerative diseases.
The company’s lead program focuses on Amyotrophic Lateral Sclerosis (ALS), a rapidly progressive disease with limited treatment options, with the goal of delivering a non-invasive, at-home therapy for people living with ALS.
What milestones have you recently completed?
Over the past year, we completed our first-in-human ALS Early Feasibility Study, confirming the safety of the MyoRegulator® device, advanced into our second clinical trial, the CALM Study, and received FDA Breakthrough Device Designation. Our first-in-human clinical trial showed that treatment with PathMaker’s MyoRegulator® device was safe, tolerable, and feasible in people with ALS, with no unexpected detrimental changes in clinical endpoints.
During this period, we expanded into Rhode Island by opening an office at CIC Providence and hiring our first Rhode Island-based team member, Sydney Bartman, Ph.D., a neuroscience graduate from the University of Rhode Island (URI). RILSH funding supported this expansion and a collaboration with Rhode Island-based CDMO Veranex to advance development of this next-generation device.
Why Rhode Island?
RILSH funding enabled our Rhode Island expansion, key hiring, and our product development partnership with Veranex. Being part of Rhode Island’s closely connected life sciences community, including collaboration with leaders at Brown University, has accelerated both our clinical and technology progress. These milestones move us closer to delivering a meaningful new treatment option for people living with ALS.
What’s next for PathMaker Neurosystems?
Over the next 6–12 months, we expect to complete our second ALS clinical trial, present new data at major scientific conferences, and prepare for a multi-center pivotal study, while continuing development of our next-generation, at-home MyoRegulator® device.
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