Latest news with #DaneAndreeff
Business Insider
12-06-2025
- Business
- Business Insider
Why Is Helius Medical Tech Stock (HSDT) Up 100% Today?
Helius Medical Technologies (HSDT) stock surged on Wednesday after the neurotech company announced an authorized claim for payment for its Portable Neuromodulation Stimulator (PoNS) from CVS Health (CVS) -owned Aetna Healthcare. This is the third time a major healthcare provider has offered to cover PoNS for a patient. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Dane Andreeff, President and CEO of Helius Medical Tech, said, '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.' PoNS is an orally applied therapy that delivers neurostimulation via a non-implantable mouthpiece. HSDT stock rocketed 98.82% during pre-market trading on Wednesday. That's a welcome change from its 91.50% drop year-to-date and 94.88% fall over the past 12 months. Is Helius Medical Technologies Stock a Buy, Sell, or Hold? Wall Street's coverage of Helius Medical Technologies is thin, but TipRanks' AI analyst Spark fills that gap. Spark rates HSDT stock an Underperform (38) with a $1 price target. The AI analyst cites 'significant financial and operational challenges' as reasons for this rating and price.
Yahoo
11-06-2025
- Business
- Yahoo
Helius Medical Technologies, Inc. Announces Authorized Claim for Payment by Major Healthcare Payer for its Portable Neuromodulation Stimulator (PoNS®) Device
-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 3rd 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 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 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 or 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 TaylorGilmartin Groupinvestorrelations@
Yahoo
11-06-2025
- Business
- Yahoo
Helius Medical Technologies, Inc. Announces Authorized Claim for Payment by Major Healthcare Payer for its Portable Neuromodulation Stimulator (PoNS®) Device
-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 3rd 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 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 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 or 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 TaylorGilmartin Groupinvestorrelations@ in retrieving data Sign in to access your portfolio Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
Helius Medical Technologies, Inc. Announces Reimbursement by Major Healthcare Provider for its Portable Neuromodulation Stimulator (PoNS®) Device
United Healthcare approves claim for PoNS Device at out-of-network adjusted list price, becoming the second payer to join Anthem in providing PoNS reimbursement NEWTOWN, Pa., May 12, 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 improving balance and gait deficits and reducing the risk of falling, today announced a reimbursement approval for the PoNS Device from a second major healthcare provider, United Healthcare. '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. We believe this pricing should support further constructive conversations with payors,' said Dane Andreeff, Helius President and Chief Executive Officer. 'We continue to pursue commercial payor coverage and broad third-party reimbursement as part of our growth strategy to increase patient access to PoNS. We are pleased with this progress in our efforts to support more MS patients.' The total lump sum approved reimbursement amount, including patient co-payment, was $18,100. This rate represents the approximate list price adjusted for the out-of-network status. 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 (PoNS®). For more information about PoNS or Helius Medical Technologies, visit 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 while 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 multiple sclerosis ('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 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 potential to expand commercial payor coverage and broad third-party reimbursement as part of the Company's growth strategy to increase patient access to PoNS. 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, market conditions and availability of funds from third parties to finance Revelation Neuro, Inc., 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 adequate 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, 2024, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at or 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 TaylorGilmartin Groupinvestorrelations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-03-2025
- Business
- Yahoo
Helius joins BCI landscape with new subsidiary
Helius Medical Technologies is muscling in on the promising brain computer interface (BCI) field with the launch of a new business focused on developing the tech. The business, called Revelation Neuro, will be a wholly owned private subsidiary focused on developing non-implantable versions of BCIs. Shares in the Nasdaq-listed company opened unchanged following the announcement. Helius Medical develops its own portable neuromodulation stimulator platform to help with movement and balance. The US company stated it will combine newly developed intellectual property (IP) with existing technology – the latter will be licensed to Revelation Neuro. While it has amassed over $70m in funding to date, Helius does not plan to pump additional capital into the subsidiary, instead opting to rely on financing through third-party sources. BCIs are chips implanted in brain tissue that take brain signals and translate them into commands. The measured signals, which can be described as 'thoughts', are relayed to a secondary, external device which then carries out a specific function. Through Revelation Neuro, Helius is opting to go down the non-implantable route. Whilst it did not reveal specifics of its planned BCI technology, a clue can be found in Helius' neuromodulation platform that uses the stimulation on the tongue to elicit brain activity. This method of modulation is known as translingual stimulation and does not require implantation. Helius' CEO Dane Andreeff said: 'We believe Revelation Neuro's BCI technology will be a unique and less invasive therapeutic option.' Revelation Neuro will also apply artificial intelligence (AI) to optimise response to the translingual stimulation, using datasets from Helius' experience in the movement dysfunction field. The algorithms will enable a precise and personalised approach to motor function rehabilitation. 'BCI-enabled improvement in functional rehabilitation is the initial focus of Revelation Neuro's efforts, with the potential in the future to address neurological conditions including cognitive deficit, mood and behaviour disorders,' Andreeff added. The BCI landscape has received plenty of public attention, primarily in part due to Elon Musk-owned Neuralink. The company has implanted two paralysed patients with its chips, helping them play video games and chess, amongst other activities. Other companies like Synchron, BrainGate, and Clinatec, are more advanced in their clinical journey but it is hard to predict when the first BCIs will reach market, although some experts reckon approvals will be seen within the decade. The US Food and Drug Administration (FDA) has already singled BCIs out due to their unique nature, issuing guidance in 2021 on their research and development. The agency shared its thoughts on a range of topics to help guide companies that are clinically testing devices but has so far remained tight-lipped on regulatory stipulates. "Helius joins BCI landscape with new subsidiary" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
