United Healthcare has approved reimbursement for Helius Medical Technologies' Portable Neuromodulation Stimulator (PoNS) device, marking a significant milestone in the company's efforts to expand access to its innovative neurological treatment. This approval makes United Healthcare the second major healthcare provider, after Anthem, to offer reimbursement for the PoNS device.
The approved reimbursement amount totals $18,100, including patient co-payment, representing the approximate list price adjusted for out-of-network status. This development signals growing recognition of the device's clinical utility in treating gait and balance deficits in patients with multiple sclerosis (MS).
"This additional claim approval and reimbursement from a second major healthcare provider at typical out of network adjusted price further validates the clinical need and benefits of PoNS and reinforces the true value of the device," said Dane Andreeff, President and Chief Executive Officer of Helius Medical Technologies. "We believe this pricing should support further constructive conversations with payors."
How the PoNS Device Works
The PoNS device represents a novel approach to neuromodulation therapy. It is a non-implantable, orally applied device that delivers mild electrical stimulation to the tongue. When used in conjunction with physical rehabilitation exercises, the neurostimulation is designed to amplify the brain's natural ability to engage physiologic compensatory mechanisms and promote neuroplasticity.
Patients typically use the device at home, where a mouthpiece connected to a controller delivers the neurostimulation during prescribed therapeutic exercise programs. This combination therapy aims to improve balance and gait while reducing fall risk in patients with neurological conditions.
Current Indications and Regulatory Status
In the United States, the PoNS device is indicated as a short-term treatment for gait deficit due to mild-to-moderate symptoms from multiple sclerosis. It is prescribed as an adjunct to a supervised therapeutic exercise program for patients 22 years of age and older.
The device has received broader authorization in Canada, where it is approved for three indications:
- Short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke, used in conjunction with physical therapy
- Short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI), used in conjunction with physical therapy
- Short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, used in conjunction with physical therapy
Additionally, the device is authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to therapeutic exercise programs to improve balance and gait.
Clinical Significance and Market Impact
The reimbursement approval from United Healthcare represents more than just financial validation for Helius Medical Technologies. It acknowledges the clinical utility of the PoNS device in addressing significant unmet needs in MS treatment.
Multiple sclerosis affects approximately 2.8 million people worldwide, with gait and balance issues being among the most debilitating symptoms that impact quality of life and independence. Traditional treatments often provide incomplete relief for these symptoms, highlighting the need for innovative approaches like the PoNS device.
"We continue to pursue commercial payor coverage and broad third-party reimbursement as part of our growth strategy to increase patient access to PoNS," Andreeff noted. "We are pleased with this progress in our efforts to support more MS patients."
Future Outlook and Strategic Direction
Helius Medical Technologies (Nasdaq: HSDT) is positioning itself as a leader in the neurotech space, focusing on neurologic deficits through its orally applied technology platform. The company views the United Healthcare reimbursement approval as a stepping stone toward broader insurance coverage and increased patient access.
The company's strategy includes:
- Expanding commercial payor coverage beyond Anthem and United Healthcare
- Pursuing broad third-party reimbursement
- Building internal commercial infrastructure
- Securing state distribution licenses
- Increasing market awareness of the PoNS device
While the company faces challenges typical of innovative medical device manufacturers—including capital requirements, manufacturing and supply chain risks, and ongoing regulatory hurdles—this reimbursement approval strengthens its position in the neuromodulation market.
As more healthcare providers recognize the value of the PoNS device, Helius Medical Technologies aims to transform the treatment landscape for patients with neurological conditions affecting gait and balance, potentially reducing fall risk and improving quality of life for millions of patients worldwide.
