PathMaker Launches Clinical Trial of MyoRegulator to Treat Spasticity, Common in MS

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MS clinical trial

PathMaker Neurosystems, Inc., recently announced the launch of an Institutional Review Board (IRB)-approved clinical trial, in partnership 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, one of the most common symptoms in multiple sclerosis (MS).

Spasticity refers to a muscle control disorder characterized by feelings of stiffness and occurrence of involuntary muscle spasms, such as sustained muscle contraction and sudden movements. There are several drug therapies for the management of spasticity, but such medicines cannot cure the condition or improve muscle coordination or strength.

The MyoRegulator is PathMaker’s first product, and consists of a non-invasive treatment for muscle spasticity based on the company’s proprietary DoubleStim technology, which provides simultaneous non-invasive stimulation at spinal and peripheral sites. According to a press release, the stimulation has been shown in animal studies to lead to the suppression of hyperexcitable spinal circuits and reduced spasticity.

MyoRegulator is an investigational device. But the company also announced that the U.S. Food and Drug Administration (FDA) has given positive confirmation that clinical trials for MyoRegulator constitute non-significant risk (NSR) device studies, and an Investigational Device Application is not necessary for the trial to proceed. Moreover, MyoRegulator was one of the first products designated for FDA’s Expedited Access Pathway (EAP), which is given for breakthrough products to facilitate development, review, and quick access to patients in need of such medical devices.

“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 the study’s lead investigator, Bruce T. Volpe, MD, investigator of the Laboratory of Biomedical Science at the Feinstein Institute. “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, which is focused on the development of neurotherapy systems, participated in the 11th Annual Neurotech Investing and Partnering Conference, held April 6–7 in Boston, Massachusetts, as part of the meeting’s Emerging Company Showcase.

According to the American Association of Neurological Surgeons, about 80 percent of people with MS have varying degrees of spasticity. The condition also affects people with cerebral palsy, spinal cord injury, brain injury, and those who have had a stroke or have other neurological disorders.

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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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    • Shasha says:

      Mg citrate may help relax muscles. Gluten/hidden gluten may hurt minerals absorbed. I need no gluten/dairy/soy/sugar/GMO..take vitamins/good oils/minerals…probiotic…LDN..detoxing. Best wishes.

    • Shasha says:

      HI, Ankle/knee swelling/inflammation/weakness maybe due to gluten/dairy/soy/sugar/GMO. Gluten is wheat/barley/rye…oats/corn. Some eat no Paleo. I eat no gluten and take LDN which helps block hidden gluten which is hard to get rid of since it can even be in the air or any food with a label including certified gluten free and nuts not sold in the shell/meat basting/some spices etc. No gluten/GMO/antibiotics etc and taking LDN may help heal the gut lining so Mg absorbs and other minerals that help the brain/body work right and it helps the immune system work right. When I ate corn it hurt knee/leg and it took two months after I stopped eating it for my leg to be ok again. Popcorn also hurt me and heated oils/saturated fat which clogs my blood vessels. Each person can figure out what food helps/hurts them with a food journal. Fish oil may lower inflammation and help brain/body. Vit C may lower allergies and help circulation. Osteoprocare taken at night relaxes my muscles in addition to more Mg taken twice in the day. I raised my MS due to recently getting Lyme which lowers Mg. Celiac/Lyme/antibiotics may lower Mg absorbed. Best wishes.

  1. Judy Leiken says:

    I have had an intrathecal Baclofen pump to control my spasticity since 1996. It helps considerably, but not enough, and when I have my dosage increased I get too dopey, confused, and tired to function. So I would very much to try the MyoRegulat

  2. Nancy Zell says:

    I have tried and used Walkaide in the past, but because of price was unable to contibue. Would love to try this !

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