Sam Brusco, Associate Editor09.14.23
PathMaker Neurosystems, a neuromodulation company developing non-invasive systems to treat serious neurological disorders, began a first-in-human clinical trial to evaluate its MyoRegulator device to treat amyotrophic lateral sclerosis (ALS).
The early feasibility study will evaluate MyoRegulator’s safety and efficacy in treating ALS patients. It’s being carried out in partnership with Spaulding Rehabilitation Hospital in Charlestown, Mass.
“We are tremendously excited to launch this first-in-human trial of MyoRegulator in ALS,” Nader Yaghoubi, MD, Ph.D., co-founder and CEO of PathMaker, told the press. “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.”
The company’s proprietary platform tech for motor neuron hyperexcitability suppression delivers simultaneous, non-invasive stimulation at spinal and peripheral sites to modulate spinal circuits. PathMaker said MyoRegulator, based on this technology, has been used safely and successfully in two completed clinical trials for post-stroke spasticity.
MyoRegulator has been designated by the U.S. Food and Drug Administration (FDA) as a breakthrough device.
The early feasibility study will evaluate MyoRegulator’s safety and efficacy in treating ALS patients. It’s being carried out in partnership with Spaulding Rehabilitation Hospital in Charlestown, Mass.
“We are tremendously excited to launch this first-in-human trial of MyoRegulator in ALS,” Nader Yaghoubi, MD, Ph.D., co-founder and CEO of PathMaker, told the press. “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.”
The company’s proprietary platform tech for motor neuron hyperexcitability suppression delivers simultaneous, non-invasive stimulation at spinal and peripheral sites to modulate spinal circuits. PathMaker said MyoRegulator, based on this technology, has been used safely and successfully in two completed clinical trials for post-stroke spasticity.
MyoRegulator has been designated by the U.S. Food and Drug Administration (FDA) as a breakthrough device.