PathMaker Neurosystems, French Brain Institute Partner on Neuromodulation Device Trials

PathMaker Neurosystems Inc. has partnered with the Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière—ICM) at the Pitié-Salpêtrière Hospital in Paris, France. PathMaker and ICM will work together to carry out human clinical trials needed to obtain CE Mark clearance for PathMaker’s MyoRegulator system, the first neuromodulation device intended for the treatment of patients suffering from neuromotor spasticity.
 
The Brain and Spine Institute is an international center of excellence in France focused on research into neurological diseases, employing more than 600 physicians and scientific researchers. PathMaker is a member company of the iPEPS-ICM bioincubator, which was established to accelerate the transformation of ideas in the neuroscience field into innovative products by furnishing an environment ideal for the development and commercialization of novel technologies.
 
“We are very pleased to be broadening our relationship with ICM,” said Nader Yaghoubi, M.D., Ph.D., president and CEO of PathMaker. “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 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.”
 
Formal clinical trials are expected to begin in France later this year, pending approval by INSERM.
 
PathMaker Neurosystems is developing non-invasive systems that treat patients suffering from neural pathway disruptions arising from conditions including stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and traumatic brain injury. There are more than 48 million affected patients in the United States, Europe, and China with these conditions. PathMaker’s first product, the MyoRegulator­ system, is intended to provide non-invasive treatment for muscle spasticity and is now being investigated in IRB-approved human clinical trials. The company’s second product, the MyoAmplifier system, is intended to provide an advanced non-invasive platform to treat paralysis and muscle weakness. The MyoRegulator and MyoAmplifier systems are considered investigational devices.
 
PathMaker Neurosystems is a clinical-stage neuromodulation company developing non-invasive systems based on the proprietary PathMaker Coordinated Multi-site Neurostimulation technology. With offices in Boston, Mass., and Paris, PathMaker is attemping to bring to market approaches to non-invasively treating neuromotor disorders. 

The Brain and Spine Institute was cofounded by private benefactors and public institutions such as Inserm, CNRS, APHP and UPMC. It aims to facilitate the rapid development of treatments for diseases of the nervous system so they can be applied to patients as quickly as possible. Its 25 research teams work independently but are associated along thematic lines that encourage the pooling of expertise and the implementation of joint projects.