PathMaker Neurosystems has started an early feasibility study investigating its non-invasive neuromodulation device in patients with amyotrophic lateral sclerosis (ALS).
The first-in-human trial will evaluate the company’s MyoRegulator device which works by suppressing motor neuron hyperexcitability via pads on the skin. These are placed at spinal and peripheral sites which then simultaneously modulates spinal circuits.
The device, which has US Food and Drug Administration (FDA) breakthrough device designation, has already proved successful in reducing muscle spasticity in stroke patients.
The French company’s early feasibility study in ALS patients is being carried out in partnership with the Spaulding Rehabilitation Hospital, in Massachusetts, US. The single-centre, open-label trial is being supported with funding from US charity Muscular Dystrophy Association (MDA). The National Institutes of Health (NIH) is also amongst additional supporters.
ALS is a progressive neurodegenerative disease that affects motor neurons needed for voluntary muscle contraction. There are limited treatment options for the disease, most of which are pharmaceutical. PatherMaker says this study could open a path for a non-pharmaceutical, non-invasive option.
A market forecast by GlobalData predicts the global neuromodulation market will be worth $14.3bn by 2033. Spinal cord stimulators make up the largest market segment.
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Whilst neuromodulation has treatment potential in neurodegenerative diseases such as ALS and Parkinson’s Disease, the therapy is also being trialled for treating migraines and cluster headaches. Abbott, a market leader in neuromodulation devices, is also using the technology to treat depression.
PathMaker’s co-founder and CEO Nader Yaghoubi said: “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.”