PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator™ PM-2200 system the Expedited Access Pathway (EAP) designation and priority processing status.
The MyoRegulator is the first product of PathMaker and it is being developed for the treatment of muscle spasticity, a muscle control disorder characterized by muscle stiffness or tightness that causes an inability to control the affected muscles. Muscle spasticity is a condition associated with several neurological disorders including multiple sclerosis.
The management of spasticity can be a challenge and it currently represents an unmet medical need. Surgical, physical and pharmacological treatments for spasticity have short-term efficacy, at best, and can cause some adverse effects.
The MyoRegulator was developed based on the company’s proprietary DoubleStim™ technology, a system that 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.
“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 EAP is a new program from the FDA, established in April 2015, with the purpose of helping patients obtain rapid access to important new medical devices by accelerating their development, assessment, and review. The MyoRegulator received the EAP designation based on its intent to treat a debilitating condition and due to the fact that it offers clinically significant benefits in comparison to other existing alternatives.
“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,” concluded Dr. Nader Yaghoubi, 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.”
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