PathMaker and Feinstein Inst launch MyoRegulator spasticity trial

PathMaker Neurosystems said today it paired with the Feinstein Institute and Northwell Health to launch an IRB-approved clinical trial of its MyoRegulator device designed to treat muscle 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.

“Initiating our company’s 1st formal human clinical trial represents a significant milestone in our strategy to rapidly and efficiently bring to market an entirely new, non-invasive approach to treating spasticity. We are delighted to be working with Northwell Health and The Feinstein Institute for Medical Research, leaders in the emerging field of bioelectronic medicine,” PathMaker CEO Dr. Nader Yaghoubi said in prepared remarks.

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.

“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. 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,” study lead investigator Dr. Bruce Volpe of the Feinstein Institute said in a prepared statement.

The company said the MyoRegulator was one of the 1st products given an Expedited Access Pathway designation from the FDA, which it won last October.

In June PathMaker inked a deal with Proven Process to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. The MyoRegulator device aims to treat muscle spasticity in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological conditions, the company said.

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