WeHealth, PathMaker Collaborating to Develop MyoRegulator as Noninvasive Treatment for Spasticity

WeHealth by Servier and PathMaker Neurosystems have established a new partnership to develop and commercialize the first neuromodulation technology for noninvasive treatment of spasticity, the companies announced.

The agreement establishes an exclusive worldwide distribution arrangement, except for the U.S. and Japan, for PathMaker’s MyoRegulator.

The MyoRegulator uses two pairs of disposable skin-surface electrodes that deliver synchronized stimulation into two sites along the neural axis, at the spinal outflow and peripheral nerve controlling the affected muscle.

This stimulatory approach is expected to modulate neural activity and suppress the excessive activity of spinal neurons that induce spasticity (uncontrolled muscle contraction), which is commonly seen in patients with neurological disorders such as multiple sclerosis (MS) and cerebral palsy.

“We are excited by WeHealth’s commitment to advancing next-generation treatments for chronic neuromotor conditions,” Nader Yaghoubi, MD, PhD, president and CEO of PathMaker, said in a press release. “This significant partnership will provide a large number of patients with access to this breakthrough non-invasive treatment through WeHealth’s international presence in more than 100 countries worldwide.”

“We look forward to the positive impact this partnership will have on the patients waiting for meaningful and safe treatment, and on the development of our company,” Yaghoubi added.

Current pharmacological, surgical, and physical treatments available to manage spasticity can only achieve short-term positive results. But these strategies can be very uncomfortable for the patients, and are also associated with unpleasant adverse reactions.

Intramuscular injections of botulinum toxin, sold under the brand names Botox and Dysport, have been approved for the treatment of spasticity in the U.S. and other countries. However, according to PathMaker, this compound has been linked to muscular weakness, breathing difficulties, pneumonia, hypersensitivity, pain, and increased mortality.

Working in collaboration with Northwell Health and the Feinstein Institute for Medical Research, based in New York, PathMaker launched a clinical trial to test MyoRegulator in patients with hand spasticity after stroke (NCT03080454).

Results of the trial, recently presented at the Society for Neuroscience meeting, revealed that patients experienced significant muscle function improvements upon five consecutive sessions of MyoRegulator-mediated stimulation. Optimal results were observed after two to three weeks of treatment on this regimen.

“The MyoRegulator device has clear and groundbreaking benefits for patients with serious neurological conditions,” said David Guez, MD, general director of WeHealth by Servier, the e-health department of Servier Group. “Our partnership with PathMaker represents an opportunity for WeHealth to contribute to the advancement of a truly novel technology that is moving the field of bioelectronic medicine forward.”

As part of the agreement, WeHealth will support an ongoing clinical trial underway at the Institut du Cerveau et de la Moelle Epinière in France. The company will also fund a larger European clinical trial intended to support reimbursement coverage.