PathMaker Neurosystems said it won expedited access pathway designation from the FDA for its MyoRegulator PM-2200 system, which is designed to treat muscle spasticity.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.
In June PathMaker inked a deal with Proven Process to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. The MyoRegulator device aims to treat muscle spasticity in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological conditions, the company said.
“The EAP designation for MyoRegulator is significant, as FDA reserves this priority review program only for devices with demonstrated potential to fill an unmet medical need and benefit patient health,” PathMaker regulatory & clinical affairs vice president Sheila Hemeon-Heyer said in prepared remarks. “We are excited to be working with FDA through the EAP program to rapidly bring to patients this important new technology for treating spasticity.”
“Through the FDA Expedited Access Pathway program, we will be able to more rapidly bring to market this breakthrough technology for treating muscle tone disorders,” added president & CEO Dr. Nader Yaghoubi. “As one of the first companies selected into this program, we look forward to working with FDA to rapidly make MyoRegulator available to patients and clinical institutions worldwide.”