FDA Grants Breakthrough Device Designation to Helius’ PoNS Device

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients.

The device, which is meant to be used in combination with therapeutic exercise programs, works by sending mild electrical signals that travel through nerves that connect the tongue — where the device is placed — to the brainstem. The brainstem is a region at the base of the brain that regulates vital functions (e.g., heart rate, respiration), as well as sensory perception and movement.

This mild electrical stimulation is thought to increase the brain’s neuroplasticity — the brain’s ability to adapt or rewire itself to preserve function following damage. The stimulation is expected to promote patients’ physical rehabilitation.

“We are extremely pleased to receive this designation for our PoNS device,” Philippe Deschamps, CEO of Helius, said in a press release.

“We look forward to working with FDA to process our application, with the ultimate goal of bringing our innovative technology to the aid of patients suffering with gait deficit due to MS-related symptoms, by providing them with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk,” Deschamps said.

The device was aapproved recently by Health Canada to treat walking/gait deficits in patients with mild-to-moderate MS when used in combination with physical therapy for a short-term basis (14-week treatment).

But in the U.S., European Union, and Australia, PoNS is still considered an investigational medical device and is not yet available commercially. In Australia, the device is under review for clearance by the Therapeutic Goods Administration (TGA).

Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment that provides significant advantages over currently available options.

It is intended to accelerate the development, review, and approval of devices that have been designed to treat or diagnose irreversibly debilitating or life-threatening conditions, so that patients and healthcare professionals may have access to these devices sooner.

The designation also comes with a series of benefits to the device’s manufacturer, including the ability to interact and receive early feedback from the FDA, and gaining eligibility for priority review.