Program Bringing PoNS Device to MS Patients at Lower Cost Extended

Access plan for adults in US with impaired gait will run through June

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Helius Medical Technologies has extended by six months a program that allows multiple sclerosis (MS) patients in the U.S. to access its Portable Neuromodulation Stimulator (PoNS) device at a reduced cost.

The Patient Therapy Access Program (PTAP) partly subsidizes the cost of using PoNS — an approved device designed to improve walking ability in patients with impaired gait — for eligible individuals with a prescription and a letter of medical necessity.

Launched in June, the program was set to expire at the end of 2022. It now will stay active until June 30, reflecting the “high interest” across the MS community, the company stated.

“Helius’s passion is helping people with MS maximize their ability to walk, and we’re excited to make cutting-edge neurotech like PoNS available to more people, more often,” Dane Andreeff, Helius’ president and CEO, said in a company press release.

“PTAP brings PoNS to people who otherwise wouldn’t be able to experience its benefits,” Andreeff added.

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PoNS works to “rewire” the brain by stimulating nerves in the tongue

PoNS is a non-invasive medical device consisting of a mouthpiece, connected via a cord to a controller worn around the neck. When placed on the tongue, the mouthpiece delivers mild electrical signals to the brain via two major cranial nerves that run through the tongue.

These electrical impulses are believed to promote neuroplasticity, or the brain’s ability to “rewire” itself in response to new experiences. It’s thought that increasing neuroplasticity could enhance the benefits of physical rehabilitation for people with MS and mild-to-moderate walking difficulties.

The PoNS device is approved in the U.S. for people, age 22 and older, with mild to moderate MS symptoms, and it is to be used in conjunction with supervised exercise programs. It’s similarly approved in Canada and Australia as a short-term treatment for MS walking difficulties in adults.

Trained physical therapists work with PoNS users for the first two weeks of the device’s program, leading them through specific exercise plans. Those weeks typically are followed by about three months of at-home use under a therapist’s guidance.

Approvals were based on findings from two clinical trials (NCT04498039 and NCT04496531) showing that PoNS, combined with a supervised exercise program, was safe and led to gait improvements, compared with exercise alone, when used for 14 weeks.

Real-world data similarly demonstrated substantial gait improvements in patients using PoNS for 14 weeks.

The PTAP extension comes on the heels of Helius’ recent announcement that eligible patients can order a PoNS device for direct shipment to their home via an e-commerce site developed in collaboration with telehealth company UpScript.

Through the platform, patients complete a brief medical questionnaire, followed by a telehealth appointment. If the patient is approved for the device, it will be shipped directly to their home.

The PTAP extension and the new digital platform are both intended to facilitate patient access to PoNS.

“Our goal is to remove as many barriers to this technology as possible,” Andreeff said. “We hope that people with MS and their caregivers consider whether PoNS is for them and if they qualify for the assistance that PTAP provides. When someone’s gait is impaired the stakes are often too high not to explore every opportunity for improvement.”

Healthcare providers can also make use of Helius’ Therapeutic Experience Program, launched last year, to gain expertise in the use of PoNS. An online training program is also open to these therapists.

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