New Muscle Spasticity Therapy Under Priority Review by FDA

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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.”

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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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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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  1. Liz says:

    Where can I find out more information on when this might be available? I need to try something soon I can not wait much longer for all these study’s!! Just get this out to people before too much time goes by and people get worse! I will try anything to get my life back! My spacticity is so bad that I can no longer leave the house and can barely get around in the house with crutches. I have been through all the current spacticity medications and none work. My legs go from not being able to bend some days to not being able to straighten out on others! Very frustrating and so painful!

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