FDA authorises Helius’ neuromodulation stimulator for gait improvement 

29 March 2021 (Last Updated March 29th, 2021 12:18)

The US Food and Drug Administration (FDA) has authorised the marketing of Helius Medical’s Portable Neuromodulation Stimulator (PoNS) as a short-term treatment for adults with gait deficit from mild to moderate multiple sclerosis (MS). 

FDA authorises Helius’ neuromodulation stimulator for gait improvement 
Photomicrograph of a demyelinating MS-Lesion. Credit: Marvin 101 on Wikipedia.

The US Food and Drug Administration (FDA) has authorised the marketing of Helius Medical’s Portable Neuromodulation Stimulator (PoNS) as a short-term treatment for adults with gait deficit from mild to moderate multiple sclerosis (MS).

A neuromuscular tongue stimulator, the device has a non-implantable apparatus to produce electrical pulses for stimulation of the trigeminal and facial nerves through the tongue to treat motor deficits.

The prescription-only device is for use as an adjunct to supervised therapeutic exercise programmes by MS patients aged 22 years and above.

FDA office of neurological and physical medicine devices acting director Christopher Loftus said: “MS is one of the most common neurological diseases in young adults.

“Today’s authorisation offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis.”

The portable, non-implantable PoNS device can provide mild neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue.

It has a controller and a mouthpiece connected by a cord. During a patient’s visit to a therapist, the mouthpiece is held in place by the lips and teeth while the control unit is worn around the neck.

Signals are sent by the controller to the mouthpiece placed on the tongue, and receptors on the tongue send millions of neural impulses through natural pathways to the brain.

Furthermore, a therapist can connect the control unit to a computer for viewing usage data via software developed for the PoNS device.

The usage data provides information on ways to enhance a patient’s execution of therapy by detecting possible areas of missed or shortened sessions.

The safety and effectiveness of the device was assessed in two clinical studies and a retrospective analysis of real-world data (RWD).

A chronic, inflammatory, autoimmune disease of the central nervous system, MS interrupts communications between the brain and other body parts.