PathMaker Neurosystems Inc. Receives Expedited Access Pathway Designation From FDA For MyoRegulator

Boston -- (BUSINESS WIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neuromodulation company developing non-invasive neurotherapy systems for the treatment of patients with neuromotor disorders, announced today that its MyoRegulator PM-2200 system has received Expedited Access Pathway (EAP) designation and priority processing status from the U.S. Food and Drug Administration (FDA). MyoRegulator is PathMaker’s first product, and is being developed for the treatment of muscle spasticity found in patients with stroke, cerebral palsy (CP), multiple sclerosis (MS), spinal cord injury (SCI), traumatic brain injury (TBI) and numerous other neurological conditions.

Management of spasticity and muscle tone disorders is currently a difficult and often insurmountable challenge, and there is tremendous unmet medical need. Pharmacological, surgical, and physical treatments to manage spasticity have, at best, short-term efficacy, and are confounded by adverse effects. MyoRegulator is based on PathMaker’s proprietary DoubleStim™ technology, providing simultaneous non-invasive stimulation at spinal and peripheral locations.

The Expedited Access Pathway is a new FDA program established April 2015 to facilitate patients gaining more rapid access to critical medical devices by expediting their development, assessment and review. The FDA has designated MyoRegulator as an Expedited Access Pathway device because it is intended to treat an irreversibly debilitating condition and because it offers significant, clinically meaningful advantages over existing legally marketed alternatives.

“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,” said Sheila Hemeon-Heyer, J.D., Vice President of Regulatory and Clinical Affairs at PathMaker Neurosystems. “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,” said Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker. “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.”

About PathMaker Neurosystems Inc.

PathMaker Neurosystems 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 (tsDCS) for patients with neuromotor disorders. More than 27 million patients in the US and Europe suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. The breakthrough non-invasive systems that PathMaker is developing are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions.