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PathMaker Neurosystems Announces Initiation of First-in-Human Trial in ALS for Non-Invasive Neuromodulation Device

Boston, MA and Paris, France – September 14, 2023 – PathMaker Neurosystems Inc. (“PathMaker”), a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announced today the initiation of a first-in-human clinical trial evaluating its MyoRegulator® device for the treatment of amyotrophic lateral sclerosis (ALS). This single-center, single-arm, open-label Early Feasibility Study (EFS) is designed to assess the safety and feasibility of the MyoRegulator® device in treating people with ALS, and is being carried out in conjunction with Spaulding Rehabilitation Hospital (Charlestown, MA).

“We are tremendously excited to launch this first-in-human trial of MyoRegulator® in ALS,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and CEO of PathMaker. “ALS is a devastating disease with tremendous unmet needs for effective treatment options. Our non-invasive approach seeks to suppress spinal motor neuron hyperexcitability, which is a key characteristic of the ALS disease process that has been found in both sporadic and familial variants of ALS. Initiating clinical evaluation of our technology in ALS is not only a significant milestone for our company, but a step towards meeting the medical needs of people living with this disease.”

PathMaker is collaborating with Leon Morales-Quezada, M.D., Ph.D., MPH, Director of the Integrative Rehabilitation Lab and Research Associate Director of the Spaulding Neuromodulation Center at Spaulding Rehabilitation Hospital, and Sabrina Paganoni, M.D., Ph.D., Associate Professor of Physical Medicine and Rehabilitation at Spaulding Rehabilitation Hospital and faculty at the Healey & AMG Center for ALS at Massachusetts General Hospital.  This first-in-human ALS trial is supported by funding from the Muscular Dystrophy Association (MDA), a leading US foundation for people living with muscular dystrophy, ALS and related neuromuscular diseases, with additional support from the Cullen Education and Research Fund (CERF), a UK philanthropy focused on ALS, and the National Institutes of Health (NIH) for PathMaker’s efforts to rapidly bring our pioneering neurotechnology to ALS.

PathMaker’s approach is based on the company’s proprietary platform technology for motor neuron hyperexcitability suppression, which provides simultaneous non-invasive stimulation at spinal and peripheral sites to modulate spinal circuits.  The MyoRegulator® device based on this technology has been used successfully and safely in two completed clinical trials for post-stroke spasticity.

More information about this ALS trial is available for prospective participants at its MassGeneralBrigham Rally page.

About PathMaker Neurosystems Inc.

PathMaker Neurosystems is a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of people with serious neurological disorders such as amyotrophic lateral sclerosis (ALS) and stroke. With offices in Boston (U.S.) and Paris (France), PathMaker is collaborating with world-class institutions on rapidly bringing to market disruptive products for treating brain and other neurological disorders with high unmet medical need. More than 48 million people in the U.S., Europe and Asia suffer profound disabilities due to ALS, stroke, spinal cord injury, multiple sclerosis, traumatic brain injury, cerebral palsy and other related neurological disorders. The MyoRegulator® platform is based on PathMaker’s proprietary technology for suppression of hyperexcitable spinal motor neurons, and is built on pioneering work by Prof. Zaghloul Ahmed, Chairman and Professor in the Department of Physical Therapy and Program in Neuroscience, City University of New York (CUNY)/College of Staten Island (CSI).  MyoRegulator® has been designated by the US Food and Drug Administration (FDA) as a “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 www.pmneuro.com.