News PathMaker, French Institute to Team on MyoRegulator Neuro-stimulation Clinical Trials PathMaker, French Institute to Team on MyoRegulator Neuro-stimulation Clinical Trials by Patricia Silva, PhD | January 25, 2017 Share this article: Share article via email Copy article link PathMaker Neurosystems and the Brain and Spine InstituteĀ (ICM) in Paris will collaborate on human clinical trials to secure CE Mark clearance for PathMakerās MyoRegulatorĀ PM-2200, a noninvasiveĀ neurotherapy technology to treatĀ conditions linked toĀ neural pathway disruption, including multiple sclerosis (MS). CE Mark āĀ whichĀ stands for “ConformitĆ© EuropĆ©enne,” or European Conformity āĀ isĀ a mandatory marking for certain products sold within the European Economic Area (EEA). It certifies that a product has met EU health, safety, and environmental requirements. āWe are very pleased to be broadening our relationship with ICM,ā Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker, said in a press release. āWith the agreements that we have recently put in place, we will be working with ICM [Institut du Cerveau et de la Moelle EpiniĆØre, it’s French name] to carry out European clinical trials for our breakthrough neuromodulation technology. This important collaboration establishes a significant cornerstone of our Companyās trans-Atlantic strategy ā gaining access to ICMās leading specialists and researchers in neuroscience, access to the specialized Clinical Investigation Centre at ICM, and obtaining exclusive rights to technology emerging in our field from ICM.ā Clinical trials are expected to begin this year in France, pending approval by the FrenchĀ National Institute of Health and Medical Research (Institut National de la SantĆ© et de la Recherche MĆ©dicale, orĀ INSERM). MyoRegulatorĀ is a non-invasive treatment for muscle spasticity (feelings of stiffness and a wide range of involuntary muscle spasms). It isĀ based on the companyās proprietary DoubleStim technology, which provides simultaneous stimulation at spinal andĀ peripheral sites. The U.S. Food and Drug Administration (FDA)Ā granted MyoRegulator Institutional Review Board (IRB)-approval for humanĀ clinical trials, and confirmed thatĀ MyoRegulator clinical trialsĀ constitute non-significant risk (NSR) device studies. The device received the FDA’s Expedited Access Pathway (EAP) designation in 2015. The designation is intendedĀ to speedĀ theĀ development, assessment, and reviewĀ of potentialĀ breakthrough products in areas of medical need. The companyās second product,Ā MyoAmplifierĀ PM-3300, based on TripleStim technology, is intended to provide simultaneous and noninvasive stimulation to cortical (motor cortex), spinal and peripheral muscle sites. It was designed to treat patients with paralysis and muscle weakness. In animal and preclinical human studies, it was shownĀ to stimulate disrupted motor pathways and enable delivery of stronger cortical signals, driving a stronger muscle response. According to the American Association of Neurological Surgeons, about 80% of people with MS have varying degrees of spasticity. The condition also affects peopleĀ withĀ cerebral palsy, spinal cord injury, brain injury, and those who have had a stroke or have other neurological disorders. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags clinical trials, France, muscle spasticity, MyoRegulator, PathMaker Neurosystems
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