The pioneering PoNS device, which uses breakthrough technology to help patients with Multiple Sclerosis (MS) correct their gait deficit, has now been rolled out into the United States as its global expansion continues.
The Portable Neuromodulation Stimulator (PoNS®) is now available to patients in the US on prescription, with its impact having been shown in Canada since 2019 in supporting with gait deficit and helping MS patients to walk.
Research shows that gait deficit is a central cause of mobility, disability and quality of life issues for the 70 per cent of the one million patients with MS in the US.
And through the introduction of the PoNS – which has received FDA authorisation for its use in short-term treatment of gait deficit due to mild to moderate symptoms of MS – a new solution is now available to improve patients’ lives, redefining traditional rehab potential and opportunity.
Helius Medical Technologies, the creator of the PoNS, is also looking to introduce its device for the treatment of dynamic gait and balance deficits as a result of stroke, having secured FDA Breakthrough Designation for the PoNS.
PoNS is a portable, non-implantable device that delivers mild electrical stimulation to the surface of the patient’s tongue. The device consists of a controller and a mouthpiece that contains gold-plated electrodes. The controller goes around the neck and the mouthpiece rests on the front of the tongue with the electrodes facing the tongue.
Electrodes send mild electrical impulses to the tongue which stimulate two cranial nerves that have direct connections into the brain through the brainstem.
When combining the PoNS device with physical activity, PoNS therapy provides a neuromodulatory effect and sets off a cascade of activity in the brain that result in consolidated neuroplastic changes and therapeutic functional outcomes, improving gait deficit in MS patients.
“We believe that we are unlocking the full potential of neuromodulation and neuroplasticity to help MS patients walk more steadily and safely,” said Dr Antonella Favit-Van Pelt, Helius’s chief medical officer.
“Approximately 40 per cent of individuals with MS will need walking assistance within 15 years of the onset of the disease. PoNS therapy provides a unique opportunity for these patients to improve gait functionality and mobility.”
The roll-out in the US is the latest milestone in the development of PoNS and its ability to support patients with MS in increasing locations around the world.
“We are extremely excited that the first patients in the United States have purchased the PoNS device on a cash pay basis to begin treatment,” says Dane Andreeff, president and CEO of Helius.
“Production of the first run of the US commercial version of PoNS systems completed earlier this month and we’ve already received 19 prescriptions.
“Two patients have received their PoNS devices to start therapy and we expect to be fulfilling additional prescriptions in the coming days and weeks.
“This is a tremendous milestone for the company as well as the nearly one million people in the US suffering from MS, and we look forward to bringing this important treatment to patients who need it.
“As previously disclosed, we expect prescriptions in the U.S. to remain on a cash pay basis for the foreseeable future as we pursue reimbursement from third-party payers and CMS. We are pleased with the reception we are receiving during the launch.”
