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New Muscle Spasticity Therapy Placed on FDA’s Fast Track

November 2, 2015

PathMaker Neurosystems Inc., a neuromodulation company focused on non-invasive therapies for neuromotor disorders, announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator PM-2200 system the Expedited Access Pathway designation and priority processing status.

The MyoRegulator is the first product of PathMaker and its being developed for the treatment of muscle spasticity, which is a condition often associated with multiple sclerosis. The EAP is a newer program implemented by the FDA, with the goal being to allow patients access to important new devices or therapies by accelerating their development.

“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 in a company news release. “We are excited to be working with FDA through the EAP program to rapidly bring to patients this important new technology for treating spasticity.”

The MyoRegulator was developed using the company’s “DoubleStim” technology as a base, which provides simultaneous non-invasive stimulation at both the spinal and peripheral locations. The DoubleStim technology has so far yielded promising results as a therapy for plasticity. The company is planning to conduct human clinical trials soon to assess the clinical value of the MyoRegulator system.