PathMaker Neurosystems Inc. has announced the establishment of a relationship with the Brain and Spine Institute, or Institut du Cerveau et de la Moelle Epinière, to conduct clinical trials needed to obtain CE mark clearance for PathMaker’s MyoRegulator, a device intended to treat of neuromotor spasticity.
“We are pleased to be broadening our relationship with [Institut du Cerveau et de la Moelle Epinière] 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 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.”
According to the release, PathMaker is developing noninvasive systems to treat patients with neural pathway disruptions caused by stroke, spinal cord injury, cerebral palsy, multiple sclerosis and traumatic brain injury. The MyoRegulator is being tested in IRB-approved human clinical trials. The device is considered an investigational device.
According to the release, PathMaker expects formal clinical trials to begin in France in 2017, pending approval from the Institut National de la Santé et de la Recherche Médicale.