PathMaker Neurosystems will team up with the Brain and Spine Institute in Paris on clinical trials of a device to help those with neuromotor spasticity, including cerebral palsy (CP) patients, manage their shaking and other symptoms.
PathMaker’s goal is to obtain European Union approval of the company’s MyoRegulator, the first neuromodulation device designed to treat neuromotor spasticity.
The MyoRegulator stimulates the spine and other locations to suppress hyper-excitable spinal impulses that trigger spasticity. Early trials indicate it could be an effective treatment for shaking and other cerebral-palsy symptoms.
“We are very pleased to be broadening our relationship with ICM [the French acronym for the Brain and Spine Institute],” Nader Yaghoubi, MD, PhD, the 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.”
ICM’s full French name is Institut du Cerveau et de la Moelle Epinière. It is part of the Pitiè-Salpêtrière Hospital in Paris.
In addition to the MyoRegulator, PathMaker is developing a product to treat the paralysis and muscle weakness that are also common in CP. The MyoAmplifier system amplifies the descending cortical signals to create stronger muscle responses that can reverse paralysis and restore muscle function and mobility.
Clinical trials of the MyoAmplifier are expected to begin in France this year. The French National Institute of Health and Medical Research (INSERM) must sign off on them before they can begin.
Surveillance of Cerebral Palsy in Europe (SCPE) says CP is Europe’s most common cause of physical disability in early childhood, affecting two to three newborns out of 1,000.
PathMaker is a member of the iPEPS-ICM bioincubator, a network established to accelerate the transformation of breakthrough ideas into innovative products by providing a research environment that promotes the development and commercialization of novel technologies.