Bioelectronic medicine firm PathMaker Neurosystems has secured a cooperative agreement with the National Institutes of Health (NIH) to develop its MyoRegulator device for the treatment of spasticity caused due to stroke.
The approximately $5m, four-year grant has been awarded under the CREATE Devices programme, which enables collaboration with the National Institute of Neurological Disorders and Stroke (NINDS).
Based on the firm’s DoubleStim technology, MyoRegulator is a neuromodulation device designed to deliver simultaneous, non-invasive stimulation at both spinal and peripheral sites to significantly minimise muscle spasticity.
PathMaker Neurosystems president and CEO Nader Yaghoubi said: “We are truly honoured and delighted to receive this support from NINDS to advance our breakthrough non-invasive neuromodulation technology that can benefit many patients in desperate need of treatment options.
“This collaborative partnership and funding will support product engineering, multi-centre US pivotal trials and regulatory submission for MyoRegulator.”
According to statistics, more than 30% of stroke survivors develop spasticity that can lead to impairments in functional movement and limited motor control.
It is expected that a non-invasive solution would work as an alternative for botulinum neurotoxin injections, which could result in serious adverse effects such as intramuscular pain due to the repeated administration and high costs.
Approved by the US Food and Drug Administration (FDA) for expedited review, MyoRegulator is currently being investigated in clinical trials in the country.
Northwell Health and the Feinstein Institute for Medical Research are responsible for these trials through a sub-award.