Helius to Survey MS Users of Emilyn App in US With Gait Problems for PoNS Device

Helius Medical Technologies partnered with Breakthrough Health on a project focused on understanding how people with multiple sclerosis (MS) in the U.S. evaluate the therapies at their disposal in terms of how well they help their ability to walk.

The collaboration will take advantage of an MS companion application, called Emilyn and developed by Breakthrough, to gather patient information. Some 30,000 MS patients worldwide are currently using Breakthrough’s app, including more than 10,000 in the U.S., Helius stated in a press release.

App users in the U.S. who agree to provide their data anonymously through a survey will be included in this collaborative project. The survey will be carried out either by email or through an app notification.

“This is a really exciting partnership for Breakthrough and the MS community. 80% of the people with MS that we queried indicated they wanted to have the opportunity to take part in research,” said Bazil Azmil, CEO of Breakthrough.

“To be able to work with Helius, and to bring people with MS into the heart of a pioneering therapy’s development is something we’re really proud of,” Azmil added. 

Survey findings will be used by Helius, which specializes in noninvasive platform technologies, to further inform the development of its portable neuromodulation stimulator (PoNS) device, and to help with how it is launched upon approved by regulatory authorities.

The PoNS device works by sending mild electrical impulses from nerves connecting the tongue to the brainstem, with a goal of increasing the brain’s neuroplasticity or ability to adapt to preserve function following damage. The device is meant to be used in combination with other physical therapy programs to promote rehabilitation in MS patients who have difficulties walking.

PoNS is approved in Canada as a short-term (14 weeks) treatment for gait deficits in people with mild to moderate MS. It is under regulatory review for clearance in the U.S. and Australia, Helius reported, but is not yet approved for use in either country or in Europe.

“This partnership with Breakthrough is an important step on the path forward for our Company, as we align in meaningful ways to potentially help MS patients with our PoNS Treatment,” said Dane Andreeff, interim president and CEO of Helius.

An estimated 50% to 80% of MS patients experience problems with gait and balance, the company reported.

The U.S. Food and Drug Administration recently designated PoNS a breakthrough device, supporting its development and helping to speed its approval review.