PathMaker Neurosystems said today it will work with France’s Brain and Spine Institute to launch a human clinical trail of its MyoRegulator neromodulation system designed to treat patients with neuromotor spasticity.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.
“We are very pleased to be broadening our relationship with ICM. 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,” PathMaker CEO & prez Dr. Nader Yaghoubi said in a press release.
PathMaker Neurosystems said it plans to initiate clinical trials in France later this year, and that data from the trials would be used to support CE Mark clearance in the European Union for the system.
Last April, PathMaker Neurosystems said it paired with the Feinstein Institute and Northwell Health to launch an IRB-approved clinical trial testing its MyoRegulator device’s ability to treat muscle spasticity.
PathMaker said it received confirmation from the FDA that clinical trials of the MyoRegulator constitute non-significant risk device studies, which allows the studies to proceed without an Investigational Device Exemption application. Such trials are assessed by the FDA and not considered to present a potential for serious risk to the health, safety or the welfare of subjects.