Overview of PathMaker Neurosystems Inc.

The MyoRegulator® is a non-invasive device that delivers PathMaker’s proprietary multi-site direct current stimulation (multi-site DCS) to the spinal cord and associated nerves. It is the first disease-modifying therapeutic device of its kind designed to target the underlying drivers of ALS neurodegeneration — motor neuron hyperexcitability and toxic protein aggregation.

The device applies low-level direct current simultaneously to multiple spinal and peripheral sites through surface electrodes placed on the skin. This multi-site approach is grounded in over a decade of research by PathMaker’s scientific team, and has been shown in gold-standard preclinical ALS models (SOD1-G93A and TDP-43) to reduce motor neuron degeneration, suppress pathological protein aggregation, improve motor function, and extend survival.

The MyoRegulator® device is designed for use in both the at-home and clinical treatment settings. The device received FDA Breakthrough Device Designation for the treatment of ALS in December 2025, is on the De Novo regulatory pathway, and is protected by over 43 issued patents in US and other major countries. The MyoRegulator® device represents an entirely new treatment modality for ALS — non-pharmacological, non-invasive, and designed from the ground up for accessibility and scalability in a home-based care model.

Over the past several years, PathMaker has been heavily focused on advancing our clinical development efforts as well as our scientific studies in gold-standard ALS models. PathMaker successfully completed its ALS Early Feasibility Study, a first-in-human trial funded by the Muscular Dystrophy Association (MDA), which confirmed the safety and feasibility of the MyoRegulator® device in people with ALS. Top-line clinical findings were presented at the recent MDA Scientific/Clinical Conference in March 2026, and a manuscript has been submitted for publication. With our clinical collaborators at Beth Israel Deaconess Medical Center (Boston, MA), we are now in the midst of the CALM trial, a state-of-the-art ALS clinical trial funded by the U.S. Department of Defense (DoD) which is further evaluating the device’s safety and efficacy in treating people with ALS. In 2025, we published the first pre-clinical findings demonstrating the efficacy of multi-site DCS in the SOD1-G93A mouse model of ALS. In 2026, we completed even more exciting pre-clinical studies in the TDP-43 model and have a follow-up TDP-43 paper submitted for publication.

PathMaker’s technology and commercial potential have been recognized and validated by a number of prestigious awards, prizes and grants from numerous organizations in the US and Europe:
• In December 2025, PathMaker received “Breakthrough Device Designation” from the U.S Food & Drug Administration (FDA) for the MyoRegulator® device for treatment of ALS, a landmark step toward regulatory approval.
• In May 2025, we received $500,000 in funding from the Rhode Island Life Science Hub (RILSH) to begin design work on our next-generation MyoRegulator ALS system.
• In June 2024, we were selected for a highly competitive $2,200,00 grant from the U.S. Department of Defense’s ALSRP program to enable us to launch our second ALS clinical trial, the CALM trial.
• In January 2023, PathMaker received an investment of $600,000 from the Muscular Dystrophy Association (MDA) to support our ALS Early Feasibility Study.
• In 2023 and 2022, we were awarded $300,000 in funding from MassVentures to support translational work on our MyoRegulator® device for ALS.
• In February 2022, we were named as recipient of the $250,000 CERF Prize in ALS for Medical Electronics by the Cullen Education and Research Fund, a UK philanthropy focused on ALS.
• In 2019, we received a NIH Phase I STTR grant of $372,000 to carry out pre-clinical studies in the SOD1-G93A model of ALS, which have now been published
• In June 2019, PathMaker was awarded the prestigious Innovation Trophy by CCI France International, France’s top award for innovation across all technology sectors.
• In May 2018, PathMaker was named recipient of the Startup of the Year Award by the French-American Chamber of Commerce of New England (FACCNE).
• In February 2018, PathMaker was awarded a $4,700,000 NIH grant to support the development of our MyoRegulator® device, which is now being used in ALS clinical trials.

Together, these achievements represent careful vetting of our company and technology, and have well positioned PathMaker to now bring the MyoRegulator® device to market and deliver an important new treatment modality for people living with ALS.

ALS affects approximately 6,000 newly diagnosed individuals each year in the United States, with roughly 34,000 people currently living with the disease. This disease destroys motor neurons in the spinal cord and brain, leading to muscle weakness, paralysis, spasticity, respiratory failure, and death, typically within 2-5 years following diagnosis. Hallmarks of the disease include motor neuron hyperexcitability and abnormal protein aggregation within motor neurons.

Despite the severity and rapid progression of ALS, only three FDA-approved therapies currently exist, and they offer limited benefit. This stark gap between clinical need and available options underscores the urgent demand for novel, effective, and accessible treatment strategies, particularly those that can be brought to market efficiently and administered outside of a clinical setting.

To address this unmet need, PathMaker has developed its proprietary Multi-Site DCS technology, delivered using the MyoRegulator® device, which is grounded in extensive preclinical and clinical research. PathMaker is advancing its MyoRegulator® device with the goal of providing people living with ALS access to a convenient, home-based treatment option capable of slowing disease progression.

As PathMaker advances the MyoRegulator® device toward commercial launch, we welcome collaboration and engagement with partners who share our vision of rapidly making ALS a livable disease, including:

1. Medtech investors with interests in neurotechnology and neurodegenerative disease, whose capital and strategic support will be instrumental in completing our pivotal RCT, achieving FDA De Novo clearance and commercial launch.
2. Strategic partners with interests in ALS who are interested in exploring long-term collaboration, investment, or co-promotion.
3. Payers and advocacy organizations interested in expanding access to this first-in-class treatment modality for ALS

PathMaker is currently seeking a modest $300,000-500,000 in bridge funding. This capital will be utilized to enable PathMaker to:

1. Complete the ongoing ALS CALM study at Beth Israel Deaconess Medical Center (Boston, MA), and position our team to analyze, present and publish the clinical findings at leading ALS conferences in late 2026 and early 2027.
2. Complete the clinical study design for our forthcoming pivotal trial, which will investigate the use of the MyoRegulator® device for ALS in an at-home treating setting, a critical step toward broad accessibility. We need to work with leading ALS clinicians, clinical trial experts and biostatisticians to comprehensively design this pivotal trial
3. Initiate FDA dialogue, leveraging our recent FDA Breakthrough Device Designation to engage in a series of pre-submissions, prepared by our regulatory consultants, that will pave the path to FDA De Novo clearance of the MyoRegulator® device and market launch for treatment of ALS.
4. Build additional MyoRegulator® devices, positioning us to be able to respond to the growing requests from ALS clinicians and patients for compassionate use treatments, as well as provide the devices necessary for the forthcoming pivotal trial.
5. File additional patent filings that will protect our innovations across the world.

This funding will take PathMaker to a major value inflection point (presentation of CALM study final results), and position the company for a subsequent institutional financing round intended for FDA regulatory clearance and the start of product sales.