What’s the best way to stimulate the brain? For Helius Medical Technologies, it’s through the tongue. Electrical stimulation of the brain to treat muscles that are weakened or dysfunctional can work, but the approach presents some challenges. Deep brain stimulation and implantable devices are invasive ways to deliver jolts.
Helius developed a device that sends electrical stimulation to the tongue. In addition to being non-invasive, this technology is also portable. The FDA recently granted marketing clearance to the Helius device as a treatment for multiple sclerosis patients who have trouble walking. It’s the first product the Newtown, Pennsylvania-based company has steered to the market and perhaps not the last. Helius says this type of neurostimulation could also find use in other areas of neurological rehabilitation.
According to the FDA, the most common walking problem associated with MS is ataxia—unsteady and uncoordinated movements that stem from damage to the part of the brain that coordinates muscle balance. When ataxia is severe, patients typically use a cane, walker, or other device to help them walk. Patients may also pursue physical therapy.
The Helius device, called Portable Neuromodulation Stimulator (PoNs), consists of a mouthpiece that is connected by a cord to a controller worn around the patient’s neck. During treatment, the controller sends signals to the mouthpiece, which sits on top of the tongue. The tongue is well suited for electric stimulation, providing a consistently moist and conductive surface area that has a high density of receptors, Helius explains in its securities filings. Those receptors send neural impulses to the brain, stimulating the trigeminal and facial nerves.
FDA authorization for PoNs clears the device as a short-term treatment for the walking problems caused by mild-to-moderate symptoms in MS patients 22 and older. The prescription product must be used in addition to a supervised therapeutic exercise program.
The FDA reviewed the results of two small clinical trials. The first was a double-blind study enrolling 20 patients, half of which received treatment with the device and the other half that were given a sham device that provided no stimulation. The main goal was to show improvement on a scale used to assess balance and walking. Patients were tested at two, six, 10, and 14 weeks. The FDA said the results showed that those in the treatment group had average scores of 7.95 according to the scale, which was a statistically significant improvement.
In the second clinical study, the effect of PoNS was tested in the cognitive and physical rehabilitation of 14 MS patients. As with the first study, participants were randomly assigned to use of the Helius device or a sham control. In the treatment group, patients showed a statistically significant improvement in sensory organization task scores at 14 weeks compared to baseline. But patients in this study did not show significant improvement in the walking assessment.
The Helius device received its first marketing authorization in Canada. Regulators there cleared the device in 2018 for treating balance problems due to mild-to-moderate traumatic brain injury. Last year, Canadian authorities granted PoNS additional authorization for treating walking problems in MS patients.
The clinical trial results were not enough for the FDA. In 2019, the U.S. agency denied Helius’s application in TBI. In securities filings, Helius said the FDA told the company that while the device’s safety profile was acceptable, the data did not provide enough information for the regulator to discern how much of the patient improvement came from PoNS and how much came from physical therapy. The FDA suggested the company resubmit its application with more data from another clinical study.
Helius designed a new clinical trial that would enroll more than 100 participants in the U.S. and Canada who have balance problems due to mild-to-moderate TBI. The company had planned to begin that study last spring until the pandemic halted clinical trials throughout the drug and medical device industries.
Helius put its own clinical trial plans on hold, but that didn’t stop the case for the device from building. Last May, the FDA granted PoNS “breakthrough designation,” a status reserved for medical devices that treat or diagnose conditions that are life-threatening or irreversibility debilitating. The designation doesn’t alter any regulatory requirements, but it does speed up the FDA’s review once an application is submitted.
The PoNS application was resubmitted last August, this time seeking FDA clearance as a treatment for MS patients. The case for the medical device was further supported by a study detailing the earlier clinical data, published last September in the peer-reviewed journal EMJ Radiology.
In addition to the two earlier clinical trials, a third set of data factored into the FDA’s evaluation. Helius included in its submission a retrospective analysis of real-world data in which PoNS was used to treat MS patients in clinical rehabilitation settings. In that analysis, as well as the two clinical trials, no serious safety problems were reported. Helius also has more than one year of real-world data from Canada which showing MS and TBI patients demonstrate improvement in balance and gait within the first two weeks of treatment and continued improvement over the next 12 weeks, according to the annual report.
“We believe the existing published data and real-world evidence with use of the PoNS for the treatment of gait disorder in patients with MS are sufficient to demonstrate a favorable risk/benefit profile, as required for de novo classification and clearance to enable U.S. marketability,” Helius said in its 2020 annual report. “Novel treatments for MS are highlighted as a specific target of the FDA as a high unmet medical need disease.”
The FDA announced the marketing authorization for PoNS on March 26. In Helius’s own announcement of the authorization, interim CEO Dane Andreef said that the company expects to U.S. sales of the device will begin in the first quarter of next year. In the near term, the company is working with the Centers for Medicare and Medicaid Services to obtain reimbursement coverage. Helius is also looking at other indications for the device including stroke, cerebral palsy, and Parkinson’s disease, according to the annual report.