PathMaker Neurosystems

PathMaker Neurosystems is a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders such as stroke and amyotrophic lateral sclerosis (ALS). The company's key product, MyoRegulator, is a non-invasive neuromodulation device that aims to suppress hyperexcitable spinal motor neurons, a characteristic of conditions like spasticity and ALS. It is based on PathMaker's proprietary DoubleStim technology, which utilizes a combination of simultaneous non-invasive spinal and peripheral stimulations.

In June 2016, PathMaker announced that the US Patent and Trademark Office had granted a fundamental patent covering the DoubleStim technology, the basis of the MyoRegulator system. MyoRegulator was one of the first products accepted into the US Food and Drug Administration's Expedited Access Pathway for breakthrough devices and has been designated as a "breakthrough medical device" by the FDA.

MyoRegulator has shown promising results in treating muscle spasticity in patients with conditions like stroke, cerebral palsy, multiple sclerosis, spinal cord injury, and traumatic brain injury. A 2019 study demonstrated significant reductions in spasticity measures and improvements in motor function after treatment with the device.

Recently, in September 2023, PathMaker initiated the first-in-human clinical trial to evaluate MyoRegulator for the treatment of ALS. Supported by funding from organizations like the Muscular Dystrophy Association and the National Institutes of Health, this single-center, single-arm early feasibility study aims to collect preliminary evidence of the device's beneficial effects in ALS patients. This marks a significant milestone for the company in exploring a non-invasive treatment option for this devastating disease.