BOSTON, MA and MANHASSET, NY – PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neurotechnology company developing non-invasive neurotherapy systems for the treatment of patients with neuromotor disorders, announced today 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.
“Initiating our Company’s first formal human clinical trial represents a significant milestone in our strategy to rapidly and efficiently bring to market an entirely new, non-invasive approach to treating spasticity,” said Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker. “We are delighted to be working with Northwell Health and The Feinstein Institute for Medical Research, leaders in the emerging field of bioelectronic medicine.”
“We are thrilled to partner with PathMaker and begin studying a new treatment that could provide relief for patients who suffer from spasticity – a serious condition that can often inhibit patients from participating in everyday activities,” said Bruce T. Volpe, MD, lead investigator of the study and professor of the department of molecular medicine at Hofstra Northwell School of Medicine. “I see patients who can no longer open doors or feed themselves as a result of suffering from spasticity. It is my hope that at the conclusion of this trial, we will see that MyoRegulator is a safe and effective treatment option.”
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 DoubleStimTM 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 DoubleStimTM technology has been shown in published animal studies to 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 was presented at the 11th Annual Neurotech Investing and Partnering Conference, held in Boston, MA on April 6-7, 2016, in the Emerging Company Showcase.
About PathMaker Neurosystems Inc.
PathMaker Neurosystems Inc. is a clinical-stage neurotechnology company founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation (tsDCS) to patients with neuromotor disorders. With offices in Boston (US) and Paris (France), PathMaker is moving forward a trans-Atlantic strategy to rapidly bring to market entirely novel, breakthrough approaches to non-invasively treating neuromotor disorders. More than 48 million patients in the US, Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. Visit the company website at www.pmneuro.com.