WeHealth, an e-health department of Servier Group, said it is in a partnership with Pathmaker Neurosystems, a pioneering clinical-stage bioelectronic medicine company. The two companies revealed plans to develop and commercialize the first neuromodulation technology designed to treat muscle spasticity non-invasively. The new technology will be known as the MyoRegulator device.
The new MyoRegulator PM-200 provides a non-invasive treatment option for patients suffering from muscle spasticity, a common condition found in many patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury, and traumatic brain injury. The condition results in certain muscles continuously contracting, resulting in an interference with normal movement, speech, and gait.
Nader Yaghoubi, president and CEO of Pathmaker, says that the new technology was one of the first devices selected under the Expedited Access Pathway (EAP) program from FDA, a program intended for breakthrough medical devices.
“The device is based on Pathmaker’s proprietary DoubleStim technology, which provides non-invasive stimulation simultaneously at spinal and peripheral sites associated with the targeted muscle,” he says. “This results in suppression of hyperexcitable spinal circuits found in patients with spasticity. The device is intended to be administered by a medical professional in a clinical setting, and treatments last 20 minutes. They will also be followed by periodic maintenance therapy.”
Current treatments for spasticity include botulinum neurotoxin injections, oral medications such as baclofen, and implantable baclofen pumps. Each of these treatment options come with their own associated adverse effects. Baclofen injections in particular can result in generalized muscular weakness, breathing difficulties, dysphagia, pneumonia, hypersensitivity, anaphylaxis, pain, and a higher mortality rate.
“Our MyoRegulator device represents the first neuromodulation approach to treating spasticity, is fully non-invasive, safe, and painless,” Yaghoubi says. “We are pleased to partner with Servier’s WeHealth organization. As part of the agreement, WeHealth will fund our ongoing European clinical trial evaluating MyoRegulator for the treatment of spasticity being conducted at France’s Brain and Spine institute at Pitié-Salpêtrière Hospital in Paris. WeHealth will also fund a larger European trial that will support reimbursement coverage.”
Recently, PathMaker presented final clinical trial results from a U.S. trial evaluating the device for the treatment of upper extremity spasticity in stroke patients at the Society for Neuroscience meeting in November of last year. The results from the trial showed that five consecutive days of MyoRegulator treatment resulted in reduction of spasticity that persists for at least five weeks.
As the company moves forward with the technology, they expect that it will receive CE mark in 2020 and be available in Europe short thereafter. In the U.S., the company expects, approval within one-to-two years of CE mark approval.
“In 2019, we are initiating a multi-center pivotal U.S. trial that is fully funded by the National Institute of Health,” Yaghoubi says. “Last year PathMaker received $5 million in funding through a program in partnership with the NIH’s National Institute of Neurological Disorders and Stroke — to support product engineering and multi-center U.S. pivotal trials and regulatory submission for the device. We believe this partnership will provide a large number of patients with access to this breakthrough, non-invasive treatment, and we look forward to the positive impact this partnership will have on patients waiting for meaningful and safe treatment.”