PathMaker Neurosystems Launches European Clinical Trial

PathMaker Neurosystems, a clinical stage company in the bioelectronic medicine space, is seeking to change the treatment paradigm of patients suffering from spasticity secondary to stroke with the MyoRegulator device. The company, which has a presence in both Boston and Paris, has initiated the first patient in its European clinical trial for the MyoRegulator. In addition, MyoRegulator is in clinical trials in the U.S. “We expect to have our first regulatory clearance in less than two years,” Dr. Nader Yaghoubi, president and CEO of PathMaker Neurosystems, told MD+DI. “We’re working to shorten that as much as we really can. Although we haven’t fully disclosed our strategy here, I will say that we will have CE mark clearance before we have FDA clearance.” The company has received significant support from FDA. In 2017, the agency selected the MyoRegulator as one of the first “breakthrough” medical devices selected for the Expedited Access Pathway (EAP) program. At the root of the MyoRegulator device is PathMaker Neurosystems’ DoubleStim technology. The company said DoubleStim uses a combination of simultaneous non-invasive spinal and peripheral stimulations. Stimulation from the device is directed to suppression of hyperexcitable spinal cord circuits that are involved in spasticity. “We really have pi...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Digital Health Source Type: news