PathMaker Neurosystems Inc., a clinical-stage neurotechnology company developing non-invasive neurotherapy systems for the treatment of patients with neuromotor disorders, recently announced that it has launched an Institutional Review Board (IRB)-approved human clinical trial in conjunction with Northwell Health (formerly North Shore-LIJ Health System) and The Feinstein Institute for Medical Research to evaluate the safety and efficacy of MyoRegulator for the treatment of spasticity, a muscle control disorder that is characterized by tight or stiff muscles and an inability to control those muscles.
PathMaker also announced that it has received positive confirmation from the U.S. Food and Drug Administration (FDA) that clinical trials for MyoRegulator constitute non-significant risk (NSR) device studies. NSR designation by the FDA allows clinical trials to proceed in the U.S. without the need to submit for approval an Investigational Device Exemption (IDE) application, because the trials, as assessed by FDA, are not considered to present a potential for serious risk to the health, safety or welfare of a subject. PathMaker’s MyoRegulator was also one of the first products designated for FDA’s Expedited Access Pathway (EAP), a new FDA pathway intended for breakthrough products to facilitate patients gaining more rapid access to critical medical devices by expediting their development, assessment and review.
MyoRegulator is a first-in-class, non-invasive device for treating patients with spasticity using our proprietary DoubleStim technology for multi-site neurostimulation. Spasticity is a common and disabling condition found in many patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, brain injury and other neurological conditions, and there are over 15 million patients worldwide affected by spasticity. Patients with spasticity have damaged neural pathways that give rise to hyperexcitable spinal circuits, and our DoubleStim technology has been shown in published animal studies to be able to suppress the hyperexcitability, thereby leading to reduced muscle spasticity. MyoRegulator is an investigational device and is limited by United States law to investigational use only.
PathMaker will be presenting at the 11th Annual Neurotech Investing and Partnering Conference, being held in Boston, MA on April 6-7, 2016, in the Emerging Company Showcase.
PathMaker Neurosystems Inc.