PathMaker Neurosystems Wins France’s Top Prize for Innovation for Spasticity Treatment

The developer of an innovative, first-in-class, noninvasive device for the treatment of spasticity in multiple sclerosis (MS) and other conditions has won the 2019 CCI France International Trophy for Innovation.

PathMaker Neurosystems was selected from a list of eight finalist companies, which were distinguished among 150 nominees from 40 countries and across all technology sectors, for its development of MyoRegulator PM-2200, a direct-nerve stimulation treatment.

This prize aims to recognize companies that produce breakthrough technology that encourages economic ties between France and French companies with the rest of the world. Award criteria include significant investments in research and development, use of new technologies, high growth potential, originality, and revolutionary projects and ideas.

The award was presented by CCI France International, a worldwide trade and development organization, at this year’s Trophees CCI France International event, held recently in Paris.

“We are incredibly honored to have been named the recipient of this award, and would like to express our sincere appreciation to the CCI France International committee for this kind recognition of PathMaker’s progress in developing MyoRegulator, our first-in-class, non-invasive device for the treatment of patients suffering from spasticity,” Nader Yaghoubi, MD, PhD, president and CEO of PathMaker, said in a press release.

“Building on the momentum we received last year from the French-American Business (FAB) Award for Startup of the Year from FACCNE [French-American Chamber of Commerce of New England], the 2019 CCI France International Trophy for Innovation is a testament to the work done by our team and collaborators in bringing this breakthrough device to patients,” he added.

Boston-based PathMaker, which has offices in Paris, is a clinical-stage bioelectronic drug company created to commercialize advances in the development of noninvasive systems for treating neuromotor disorders, including MS and cerebral palsy. In addition to spasticity, Pathmakers’ new device was designed to treat muscle weakness and paralysis.

The company’s first product, MyoRegulator is based on PathMaker’s proprietary DoubleStim technology, and uses electrical stimulus to regulate nerve cell activity. It suppresses the overreaction that causes spasticity. The technology uses two pairs of disposable skin-surface electrodes to deliver simultaneous stimulation to two sites along the central nervous system (neural axis) — at the spinal outflow and at the peripheral nerve controlling the affected muscle.

The beneficial effect of this direct-nerve stimulation treatment approach was described in a preclinical study, published in January in The Journal of Physiology. The study demonstrated that treatment with MyoRegulator could effectively ease spasticity in mice with spinal cord injury after seven straight days of 20-minute therapy sessions. Compared to those that weren’t treated, these mice also showed marked and sustained improvements in moving from one place to another.

In collaboration with Northwell Health and the Feinstein Institute for Medical Research, PathMaker launched an Institutional Review Board-approved clinical trial (NCT03080454) to assess the effects of MyoRegulator in patients with hand spasticity after stroke. Trial results showed that participants experienced significant muscle function improvements following five straight sessions of MyoRegulator-mediated stimulation.

On its website, PathMaker calls treatments for spasticity an unmet need. “Pharmacological, surgical and physical treatments to manage spasticity have, at best, short-term efficacy, are compounded by adverse affects, and are often unpleasant for the patient,” the company says.

One of the most common MS symptoms, spasticity causes muscles to feel stiff and heavy, making movement difficult. It affects between 60 and 90% of MS patients at some point during disease progression. Spasticity may or may not occur frequently, and can differ in its effects not only from person to person, but within the same patient. It can affect walking, balance and occasionally speech, and may result in uncontrollable spasms. Spasticity is caused by damage to nerve pathways that control movement.

To date, the two most common treatments for spasticity are muscle relaxers Lioresal (baclofen) and Zanaflex (tizanidine). Valium (diazepam) is often used to relieve spasms that interfere with sleep. Some patients in the U.S. and other countries use botulinum toxin — also known as Botox — for spasticity. However, this compound, according to Pathmaker, has been linked to conditions including muscle weakness, hypersensitivity and pain, as well as increased mortality.

In an exclusive global distribution arrangement, excluding the U.S. and Japan, PathMaker and WeHealth by Servier early this year established a partnership to develop and commercialize MyoRegulator.