Helius Medical Technologies, Inc. Announces Authorized Claim for Payment by Major Healthcare Payer for its Portable Neuromodulation Stimulator (PoNS®) Device

Rhea-AI Summary

Helius Medical Technologies (NASDAQ: HSDT) has secured authorization for payment from Aetna Healthcare for its PoNS Device at an out-of-network negotiated price of $18,350. This makes Aetna the third major healthcare payer to provide PoNS reimbursement, joining Anthem and United. The PoNS Device, designed for balance and gait deficits, is currently reimbursed by VA/DoD at $26,228. CEO Dane Andreeff emphasized that out-of-network reimbursement is just the first step, as the company actively pursues broader in-network coverage at list price and continues negotiating case-by-case reimbursements. The company is also working towards securing Medicare coverage for MS patients. The negotiated out-of-network price represents a 30-40% reduction from typical in-network contracted payment rates.

Positive

• Third major healthcare payer (Aetna) joins in providing PoNS reimbursement coverage
• Secured authorization for payment at $18,350, showing growing insurance acceptance
• Current VA/DoD reimbursement rate of $26,228 demonstrates higher potential for in-network pricing
• Company actively pursuing broader in-network coverage with major commercial payers

Negative

• Out-of-network price is 30-40% below in-network contracted payment rates
• Authorized claim may not result in immediate device sale due to individual deductibles and out-of-pocket costs
• Medicare coverage still pending, limiting access for MS patients on Medicare
• Case-by-case negotiation still required for many reimbursements

Insights

Healthcare Reimbursement Expert

Aetna's PoNS reimbursement approval marks important progress for Helius, though out-of-network status limits immediate revenue impact.

The authorization of a $18,350 out-of-network payment by Aetna for Helius Medical's PoNS device represents a significant milestone in the company's reimbursement strategy. With Aetna joining Anthem and United Healthcare, Helius has now secured coverage decisions from three of the largest commercial insurers in the US market.

This out-of-network authorization is particularly noteworthy in the medical device reimbursement landscape. The $18,350 negotiated price—typically 30-40% below potential in-network rates—establishes a crucial pricing benchmark. While lower than the $26,228 rate secured from VA/DoD, gaining commercial payer recognition is often more challenging and represents essential progress in market access development.

The company's candid acknowledgment that this specific claim may not translate to an immediate sale reveals the complexity of the reimbursement landscape. Patient-specific factors like deductibles and out-of-pocket maximums will ultimately determine if and when authorized claims convert to actual revenue. This transparency suggests realistic expectations about near-term financial impact.

Securing these initial out-of-network approvals typically serves as the foundation for subsequent negotiations for more favorable in-network coverage. The progressive accumulation of commercial payer decisions also strengthens Helius's position in pursuing Medicare coverage—a critical channel for MS patients who disproportionately rely on government insurance programs.

Medical Device Market Analyst

Third major payer approval establishes PoNS commercial viability, creating pathway to broader coverage despite out-of-network limitations.

Helius's announcement of Aetna's payment authorization for their PoNS neuromodulation device marks a crucial transition point in the product's commercialization journey. Securing reimbursement from a third major commercial payer demonstrates growing recognition of the device's value proposition in treating balance and gait deficits in multiple sclerosis patients.

For novel neurotechnology devices, establishing initial reimbursement precedents is often the most challenging commercialization hurdle. Each additional payer approval creates momentum, as insurers frequently reference peer decisions when evaluating coverage policies. This "domino effect" pattern is evident as Helius has now secured authorizations from Anthem, United, and Aetna in relatively quick succession.

The price point differential between the $18,350 out-of-network negotiated rate and the $26,228 VA/DoD benchmark provides important insight into Helius's pricing strategy. The company appears to be willing to accept lower initial rates to establish reimbursement precedents, while simultaneously working toward the higher benchmark for long-term commercial contracts.

The company's pursuit of in-network coverage will be crucial for volume growth. Out-of-network arrangements often come with higher patient cost-sharing requirements that can limit accessibility and adoption, particularly for devices with five-figure price tags. The systematic approach of securing multiple out-of-network approvals before pursuing in-network status follows standard medical device commercialization protocols for innovative technologies.

-Aetna authorizes claim for PoNS Device at out-of-network negotiated price of $18,350, becoming the third payer to join Anthem and United in providing PoNS reimbursement-

-Out of Network reimbursement is only the first step towards expanding third-party paid access to PoNS-

NEWTOWN, Pa., June 11, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced an authorized claim for payment for the PoNS Device from a third major healthcare provider, Aetna Healthcare.

“The recent reimbursement approvals from two major commercial healthcare payers, with a third underway, mark significant milestones for Helius and the MS community,” said Dane Andreeff, Helius’ President and Chief Executive Officer. “We are actively pursuing broader in-network coverage for PoNS at list price from major commercial payers, while continuing to negotiate reimbursement on a case-by-case basis. We expect to continue our efforts in expanding patient access and ensuring consistent reimbursement as we work to align commercial payments with the rates currently offered by the VA/DoD at $26,228. At the same time, we remain firmly committed to supporting individuals with MS who rely on Medicare for PoNS treatment and believe this, along with other 3^rd party payer reimbursement decisions will benefit our continued efforts to secure fair and adequate reimbursement by CMS for the PoNS system.”

The out-of-network price, which typically is 30 to 40% below in-network contracted payment rates of $18,350, was negotiated and accepted by Aetna Healthcare to fulfill the prescription of the PoNS Device for an individual with multiple sclerosis. Depending on the individual’s deductible and out-of-pocket costs, this claim may not result in an immediate PoNS Device sale.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS^® or Helius Medical Technologies, visit www.heliusmedical.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding commercial reimbursement of the PoNS Device and the uses and effectiveness of PoNS and PoNS Therapy.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact 

Philip Trip Taylor
Gilmartin Group
investorrelations@heliusmedical.com

FAQ

What is the reimbursement price approved by Aetna for the HSDT PoNS Device?

Aetna approved an out-of-network negotiated price of $18,350 for the PoNS Device.

How many major healthcare payers now cover Helius Medical's PoNS Device?

Three major healthcare payers now cover the PoNS Device: Aetna, Anthem, and United.

What is the VA/DoD reimbursement rate for HSDT's PoNS Device?

The VA/DoD currently reimburses the PoNS Device at $26,228.

Does Medicare currently cover Helius Medical's PoNS Device?

No, Medicare coverage is not yet secured, but the company is working to obtain CMS reimbursement for the PoNS system.

What is the difference between in-network and out-of-network pricing for the HSDT PoNS Device?

The out-of-network price is typically 30-40% below in-network contracted payment rates.