PathMaker Launches Clinical Trial of MyoRegulator to Treat Spasticity, Common in MS

PathMaker Neurosystems, Inc., recently announced the launch of an Institutional Review Board (IRB)-approved clinical trial, in partnership with Northwell Health (formerly North Shore-LIJ Health System) and The Feinstein Institute for Medical Research, to evaluate the safety and efficacy of MyoRegulator for the treatment of spasticity, one of the most common symptoms in multiple sclerosis (MS).

Spasticity refers to a muscle control disorder characterized by feelings of stiffness and occurrence of involuntary muscle spasms, such as sustained muscle contraction and sudden movements. There are several drug therapies for the management of spasticity, but such medicines cannot cure the condition or improve muscle coordination or strength.

The MyoRegulator is PathMaker’s first product, and consists of a non-invasive treatment for muscle spasticity based on the company’s proprietary DoubleStim technology, which provides simultaneous non-invasive stimulation at spinal and peripheral sites. According to a press release, the stimulation has been shown in animal studies to lead to the suppression of hyperexcitable spinal circuits and reduced spasticity.

MyoRegulator is an investigational device. But the company also announced that the U.S. Food and Drug Administration (FDA) has given positive confirmation that clinical trials for MyoRegulator constitute non-significant risk (NSR) device studies, and an Investigational Device Application is not necessary for the trial to proceed. Moreover, MyoRegulator was one of the first products designated for FDA’s Expedited Access Pathway (EAP), which is given for breakthrough products to facilitate development, review, and quick access to patients in need of such medical devices.

“We are thrilled to partner with PathMaker and begin studying a new treatment that could provide relief for patients who suffer from spasticity — a serious condition that can often inhibit patients from participating in everyday activities,” said the study’s lead investigator, Bruce T. Volpe, MD, investigator of the Laboratory of Biomedical Science at the Feinstein Institute. “I see patients who can no longer open doors or feed themselves as a result of suffering from spasticity. It is my hope that at the conclusion of this trial, we will see that MyoRegulator is a safe and effective treatment option.”

PathMaker, which is focused on the development of neurotherapy systems, participated in the 11^th Annual Neurotech Investing and Partnering Conference, held April 6–7 in Boston, Massachusetts, as part of the meeting’s Emerging Company Showcase.

According to the American Association of Neurological Surgeons, about 80 percent of people with MS have varying degrees of spasticity. The condition also affects people with cerebral palsy, spinal cord injury, brain injury, and those who have had a stroke or have other neurological disorders.