PathMaker’s MyoRegulator device works by suppressing motor neuron hyperexcitability via pads on the skin. Credit: Kateryna Kon via Shutterstock.

Neuromodulation company PathMaker Neurosystems has secured $2.16m from the US Department of Defense (DoD) to fund a clinical trial using its MyoRegulator investigational device to treat people with amyotrophic lateral sclerosis (ALS). 

The funding comes from the congressionally directed medical research programme (CDMRP) at the DoD US Army Medical Research and Development Command (USAMRDC), as part of its FY 2023 ALS research programme (ALSRP) pilot clinical trial award. It will be used to fund PathMaker’s expanded pilot CALM study, set to begin later this year at the Spaulding Rehabilitation Hospital (SRH) and Beth Israel Deaconess Medical Center (BIDMC) in Boston, US. 

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PathMaker’s MyoRegulator device works by suppressing motor neuron hyperexcitability via pads on the skin. These are placed at spinal and peripheral sites which then simultaneously modulate the spinal circuits.  

The France-based company has already tested the device in two studies, including one for post-stroke spasticity, and a first-in-human early feasibility study for ALS. The single-centre, open-label ALS trial (NCT06165172) enrolled five patients who received treatment using the MyoRegulator device three times a week. This trial was supported with funding from US charity Muscular Dystrophy Association (MDA).  

Although it’s not known exactly what drives motor neuron dysfunction in ALS, one process that is thought to play a role in motor neuron hyperexcitability. There are limited treatment options for the disease, most of which are pharmaceutical. According to GlobalData epidemiologists, there will be 80,483 cases of ALS in the eight major markets (US, UK, France, Spain, Italy, Germany, Japan, and Canada) by 2029.  

Innovation in the neuromodulation space is increasing, with devices being tested for migraine, depression, and other neurological and psychiatric disorders. In January 2024, SpineX announced positive results from a first-in-human study evaluating the use of its electrical neuromodulation device in a patient with cerebral palsy. US-based Neuronoff is investigating its implantable neuromodulation device Injectrode in a first-in-human study for chronic pain management. 

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PathMaker’s co-founder and CEO Nader Yaghoubi said: “We are very pleased to have DoD’s support as we launch our second clinical trial for our non-invasive ALS neuromodulation platform. We’ve had a team of noted and world-class co-investigators come together to help design and run this state-of-the-art ALS trial, and we look forward to getting enrolments underway in the coming months to expand our evidence base.”