Overview of Enabling Compassionate Use Treatment of ALS using the MyoRegulator Device
PathMaker Neurosystems is a clinical-stage neurotechnology company developing a novel, non-invasive treatment for ALS (amyotrophic lateral sclerosis). We are advancing our proprietary non-invasive technology, multi-site direct current stimulation (multi-site DCS), which uses electrical fields to suppress neuronal hyperexcitability and reduce TDP-43 and SOD1 protein aggregation, core drivers of the large majority of ALS cases. Our flagship product, the MyoRegulator® device, delivers this breakthrough technology as a first-in-class treatment modality designed for use in the at-home and clinical treatment settings. The device has undergone pre-clinical validation, has been taken through 2 ALS clinical trials, and recently received FDA Breakthrough Device Designation for the treatment of ALS. Top-line results from our U.S. Department of Defense (DoD)-funded CALM trial are being presented at major ALS conferences in late 2026.
Our Ask
After nearly a decade of engineering, pre-clinical research and clinical trials, PathMaker has pioneered an entirely new and non-invasive approach to the treatment of ALS. As clinical evidence for the MyoRegulator® device continues to build, we are receiving a growing number of requests from people with ALS (pALS) and their families for compassionate use treatment. Our ability to accommodate compassionate use treatment requires the manufacture of MyoRegulator® devices and disposable electrodes sets that are used for the delivery of compassionate use treatment. We are seeking support to fund the PathMaker Compassionate Use Program (EAP), which will enable a limited number of people living with ALS to receive MyoRegulator® treatments in the at-home treatment setting, at no cost to them or their family. Specifically, funding is needed to cover device fabrication, electrode set manufacturing and supplies for each compassionate use request. Our ask is approximately $100,000 in initial non-dilutive or charitable funding, directed through the disAbled Life Foundation, to support an initial number of compassionate use requests. We also welcome introductions to ALS foundations and charitable organizations, mission-aligned philanthropists, and clinical partners at ALS centers of excellence who can help expand access to this first-in-class, non-invasive treatment for pALS who prefer or need to seek compassionate use treatment now.
Institution & Principal Investigator
Institution/Organization Name: PathMaker Neurosystems Inc.
Principal Investigator: Nader Yaghoubi, M.D., Ph.D. – Co-Founder and Chief Executive Officer, PathMaker Neurosystems
Research Capital Needs & Timeline
Amount of Capital Required: $100K in initial non-dilutive funding.
Budget Priorities:
1. Manufacture of disposable electrode sets for compassionate use treatment
2. Manufacture of additional MyoRegulator devices for compassionate use treatment
3. Provision of necessary supplies and equipment for compassionate use treatment at-home
Timeline: Funding is being sought for Q3 2026
Research Status & Prior Funding
Over the past several years, PathMaker has been heavily focused on advancing our clinical development efforts as well as our scientific studies in ALS models. In 2025, we published our 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 in peer-review for publication. Clinically, 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. With our clinical collaborators at Beth Israel Deaconess Medical Center (Boston, MA), we are now nearing completion on the CALM trial, a state-of-the-art ALS clinical trial funded by the U.S. Department of Defense (DoD) CDMRP ALSRP which is further evaluating the device’s safety and efficacy in treating people with ALS. To achieve this work, we have received 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.
Research Team & Collaboration
The PathMaker leadership team has been working together for many years, building a foundation of operational trust and shared vision. This is precisely the right team to advance PathMaker’s mission; collectively, the founders and senior leaders bring over 120 years of combined experience spanning medical device engineering, regulatory and clinical affairs, IP commercialization, bioelectronic medicine research, life science company formation, and neurodegeneration.
Nader Yaghoubi, M.D., Ph.D. serves as PathMaker’s full-time Co-Founder and CEO and as Principal Investigator on this Research Project. He has over 25 years of experience in the creation, operations, and financing of life science companies. He has served as Principal Investigator on funded grants from the National Institutes of Health (NIH), Muscular Dystrophy Association (MDA) and U.S. Department of Defense (DoD). Dr. Yaghoubi received an M.D. and Ph.D. in Molecular Pharmacology from the combined degree program at Boston University School of Medicine, and did his undergraduate studies in Biochemistry at the University of Arizona. His doctorate work on the development of high-throughput automated electrophysiological systems resulted in five issued US patents, received one of the University’s highest awards for dissertational research, and was the basis of a venture-backed biotechnology company focused on neuroscience.
Jerry Jennings, B.S.E.E. serves as PathMaker’s Chief Technology Officer, where he leads the PathMaker engineering team and brings over twenty-five years of experience in engineering and R&D leadership of medical device development teams.
Jake Maslow, J.D. serves as PathMaker’s full-time Executive Vice President and CIPO and has 30 years of experience in various aspects of entrepreneurialism and IP commercialization, including recognition of innovation and commercial opportunity in new technologies, assisting startups and business formation, managing team formation and strategic growth, fund raising, strategic partnering, high-tech new product development and marketing, university licensing, and corporate and IP law.
Michail Pankratov, M.D., Ph.D. serves as PathMaker’s part-time VP of Regulatory and Clinical Affairs and brings over 30 years of expertise in clinical and regulatory affairs across a broad range of medical device fields. Dr. Pankratov currently serves as Founder and Principal of Med-Device Clinical & Regulatory Consulting, where he provides expert clinical and regulatory consulting services to the medical device industry.
Zaghloul Ahmed, Ph.D. serves as PathMaker’s Scientific Founder, Consultant, and Scientific Advisory Board Member, where he is currently Chairman of the Department of Physical Therapy and Associate Professor in Neuroscience and Motor Control at CUNY/College of Staten Island. Dr. Ahmed is best known for his research in bioelectronic medicine, which has had significant practical implications, and focuses on the innovative application of therapeutic strategies based on electrical and magnetic stimulation.
Sydney Bartman, Ph.D. serves as PathMaker’s full-time Research Operations Manager, where she leads the company’s operational infrastructure and has more than seven years of specialized expertise in neurodegenerative disorders.
PathMaker will also work in collaboration with multiple partner sites such as ALS multi-disciplinary clinics, ALS foundations, and other charitable organizations.