PathMaker Neurosystems and the Brain and Spine Institute (ICM) in Paris will collaborate on human clinical trials to secure CE Mark clearance for PathMaker’s MyoRegulator PM-2200, a noninvasive neurotherapy technology to treat conditions linked to neural pathway disruption, including multiple sclerosis (MS).
CE Mark — which stands for “Conformité Européenne,” or European Conformity — is 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.
“We are very pleased to be broadening our relationship with ICM,” Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker, said in a press release. “With the agreements that we have recently put in place, we will be working with ICM [Institut du Cerveau et de la Moelle Epinière, it’s French name] to carry out European clinical trials for our breakthrough neuromodulation technology. This important collaboration establishes a significant cornerstone of our Company’s trans-Atlantic strategy — gaining access to ICM’s 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.”
Clinical trials are expected to begin this year in France, pending approval by the French National Institute of Health and Medical Research (Institut National de la Santé et de la Recherche Médicale, or INSERM).
MyoRegulator is a non-invasive treatment for muscle spasticity (feelings of stiffness and a wide range of involuntary muscle spasms). It is based on the company’s proprietary DoubleStim technology, which provides simultaneous stimulation at spinal and peripheral sites.
The U.S. Food and Drug Administration (FDA) granted MyoRegulator Institutional Review Board (IRB)-approval for human clinical trials, and confirmed that MyoRegulator clinical trials constitute non-significant risk (NSR) device studies.
The device received the FDA’s Expedited Access Pathway (EAP) designation in 2015. The designation is intended to speed the development, assessment, and review of potential breakthrough products in areas of medical need.
The company’s second product, MyoAmplifier 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 shown 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 people with cerebral palsy, spinal cord injury, brain injury, and those who have had a stroke or have other neurological disorders.