PathMaker Neurosystem Inc, Boston, announces in a media release that its MyoRegulator PM-2200 system has received Expedited Access Pathway (EAP) designation from the US Food and Drug Administration (FDA).
The MyoRegulator system, the company’s first product, is being developed by the company for the treatment of muscle spasticity found in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, and numerous other neurological conditions.
The device is based on PathMaker’s proprietary DoubleStim technology, which provides simultaneous noninvasive stimulation at spinal and peripheral location. It is receiving the EAP designation because it is intended to treat an irreversibly debilitating condition and because it offers significant, clinically meaningful advantages over existing legally marketed alternatives, the release explains.
“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,” says Sheila Hemeon-Heyer, JD, vice president of Regulatory and Clinical Affairs at PathMaker Neurosystems, in the release.
“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,” says Nader Yaghoubi, MD, PhD, president and CEO of PathMaker, per the release.
According to the release, PathMaker Neurosystem Inc is a clinical-stage neuromodulation company founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation for patients with neuromotor disorders.
[Source(s): PathMaker Neurosystems Inc, Business Wire]