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NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a medical device company with a market capitalization of $0.45 million, announced Wednesday that Aetna Healthcare has authorized a claim for the company’s Portable Neuromodulation Stimulator (PoNS) device at an out-of-network negotiated price of $18,350. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it faces challenges with rapid cash burn.
This makes Aetna the third major healthcare provider to reimburse for the PoNS device, following similar decisions by Anthem and United Healthcare, according to the company’s press release statement. This development comes as InvestingPro analysis shows the company’s revenue declined by 35% in the last twelve months, with analysts forecasting further sales decline in the current year.
The PoNS device is a non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece to improve balance and gait. It is FDA-authorized as a short-term treatment for gait deficit due to mild-to-moderate multiple sclerosis symptoms in patients 22 years and older, when used with a supervised therapeutic exercise program.
Dane Andreeff, President and CEO of Helius, said the company is pursuing broader in-network coverage for PoNS at list price while continuing to negotiate reimbursement on a case-by-case basis.
The out-of-network price of $18,350 is typically 30-40% below in-network contracted payment rates, according to the company. Helius noted that depending on the individual’s deductible and out-of-pocket costs, this claim may not result in an immediate device sale.
Helius stated it is working to align commercial payments with the $26,228 rate currently offered by the VA/DoD while also seeking to secure reimbursement from the Centers for Medicare & Medicaid Services (CMS).
The PoNS device has also received authorization for sale in Canada for treatment of gait deficit due to stroke and multiple sclerosis, as well as chronic balance deficit due to mild-to-moderate traumatic brain injury. It is also authorized in Australia as an adjunct to therapeutic exercise programs to improve balance and gait. Despite these market opportunities, InvestingPro reports weak gross profit margins and significant stock volatility. For deeper insights into HSDT’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, which provides detailed analysis of the company’s performance metrics and future outlook.
In other recent news, Helius Medical Technologies announced that United Healthcare has approved reimbursement for its Portable Neuromodulation Stimulator (PoNS) device for multiple sclerosis patients, joining Anthem as a major healthcare provider offering coverage. The reimbursement is set at an out-of-network adjusted list price of $18,100, including patient co-payment. Additionally, Helius Medical revealed a 1-for-15 reverse stock split of its Class A common stock, effective May 1, 2025, to maintain compliance with Nasdaq’s listing standards. The reverse stock split will consolidate every 15 shares into one, reducing the total number of outstanding shares from approximately 7.9 million to about 0.5 million.
Furthermore, Helius secured $1.3 million in a private placement deal through a securities purchase agreement involving unsecured promissory notes and common stock shares. The company plans to use the proceeds for working capital and general corporate purposes. In another development, Helius launched a private subsidiary, Revelation Neuro, Inc., focusing on AI-powered brain-computer interface technology to enhance neurorehabilitation. This subsidiary aims to improve functional rehabilitation outcomes and will be financed through external sources. Lastly, Helius achieved compliance with Nasdaq’s minimum bid price requirement but must demonstrate compliance with the Nasdaq’s Equity Rule by June 30, 2025, to maintain its listing.
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