Latest news with #HeliusMedicalTechnologies
Yahoo
4 days ago
- Business
- Yahoo
Helius Medical Technologies, Inc. Compliant with Nasdaq Bid Price Rule Listing Criteria
Company previously granted extension until June 30, 2025 to regain compliance with Nasdaq's Equity Rule requirement NEWTOWN, Pa., June 04, 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 that on June 3, 2025, Helius received formal notice from the Nasdaq Hearings Panel of The Nasdaq Stock Market LLC (the 'Panel') indicating that Helius has evidenced full compliance with the minimum bid price requirement set forth Listing Rules 5550(a)(2) (the 'Bid Price Rule'). The Panel further reminded the Company that it is also required to regain compliance with the equity requirement in Listing Rule 5550(b)(1) (the 'Equity Rule') by June 30, 2025 under the extension previously granted by the Panel. Accordingly, the Nasdaq Listing Qualifications hearing process will remain open until the Company has demonstrated compliance with all of The Nasdaq Stock Market's continued listing requirements. 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 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, but are not limited to, statements regarding the Company's ability to achieve and maintain compliance with the Nasdaq listing rules. 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
20-05-2025
- Health
- Yahoo
Helius to Spotlight Study Confirming Improved Long-Term Outcomes from Adherence to PoNS Therapy® at CMSC Annual Meeting
Shepherd Center's Dr. Deborah Backus to Showcase Final Results of PoNSTEP Study, Providing New Insight into Maximizing Impact of Neuromodulation to Improve Gait in People with MS NEWTOWN, Pa., May 20, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced it will highlight the results of a new study confirming the therapeutic regimen and sustained efficacy of its Portable Neuromodulation Stimulator (PoNS®) device for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The event runs from May 28-31 at the Phoenix Convention Center in Phoenix. Deborah Backus, PT, Ph.D., FACRM – Vice President of Research and Innovation at Atlanta's Shepherd Center, one of six sites that conducted the PoNS Therapeutic Experience Program (PoNSTEP) study – will present the full study results for the first time at a platform presentation session on Thursday, May 29, from 3:20-3:40 p.m. Attendees can learn more about PoNSTEP from Helius Chief Medical Officer Antonella Favit-Van Pelt, M.D., Ph.D., who will meet attendees at booth 600 to answer questions and discuss the study outcomes in more detail. 'Those of us familiar with PoNS have seen how it enables some people with MS to walk better. But PoNSTEP data provide the first clinical evidence that there's a statistically significant relationship between adherence to PoNS Therapy and the degree of improvement – and that the improvement can be sustained,' Dr. Backus said. 'These results affirm the potential of PoNS Therapy to drive real, measurable gain in better mobility for people with MS. For a population that has long faced limited treatment options for gait deficits, this represents an important step forward.' PoNSTEP was a three-phase, real-world therapeutic experience study designed to assess the impact of adherence on gait deficit and long-term outcomes. Participants began with two weeks of supervised in-clinic therapy, followed by 12 weeks of combined clinic and at-home use, and concluded with a six-month follow-up period to evaluate the durability of their improvements. PoNSTEP's key finding is that stronger adherence to PoNS Therapyä, which combines non-invasive cranial nerve translingual neuro-stimulation (TLNS) with specific physical exercises, results in better therapeutic outcomes. The most-adherent participants maintained superior gait improvement from the end of the study's supervised therapy phase through its unsupervised therapy phase, achieving a gain of over 6 points in their Dynamic Gait Index (DGI) scores – a key clinical measurement of walking function and balance – over the first 14 weeks of the trial. PoNSTEP data also show gait improvement levels are durable, sustained at 6 months post-treatment. Highly adherent patients—using the device for at least 85% of the recommended 100–120 minutes per day during Phase 2—improved their Dynamic Gait Index (DGI) scores by more than 6 points. Those with moderate adherence (around 70%) showed a smaller, yet meaningful, improvement of 5 points total. These results demonstrate a linear relationship between adherence and gait improvement outcomes. In addition, more than 95% of participants who were evaluated 6 months later maintained their level of improvement. 'PoNSTEP is the latest in a series of important milestones for PoNS and I'm delighted to join Dr. Backus in sharing PoNSTEP full study results with the broader MS community,' said Dr. Favit-Van Pelt. The study provides further evidence of the power of neuromodulation and neuroplasticity in rehabilitating the neural network and confirms the benefit of 14 weeks of PoNS therapy as a meaningful therapeutic option for people with MS and gait deficit. Access to PoNS therapy is provided by insurance through the U.S. Department of Veterans Affairs and U.S. Department of Defense, with several commercial healthcare providers already starting to reimburse the device out of network. About PoNS Therapeutic Experience Program (PoNSTEP) The Therapeutic Experience Program ('TEP') is a Helius-sponsored, open-label, observational, interventional multi-center outcome research study designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis ('MS') in a real-world clinical setting. The study aims to understand better the relationship between adherence to on label (100-120 minute per day) PoNS Therapy, which combines the PoNS device with physical therapy, and the therapeutic outcome on gait deficit improvement over 14 weeks of study treatment, as measured by changes in the Dynamic Gait Index (DGI) scores. PoNS therapy is applied in a supervised clinical setting for the first two weeks (Phase 1) and, independently, at home for the remaining 12 weeks (Phase 2). The study also includes a six-month no-treatment follow-up phase aimed at establishing the durability of the therapeutic effect (Phase 3). The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject's adherence to PoNS therapy. The secondary endpoints are, among others, maintenance of improvement of gait and balance deficit over a 6-month timeframe and clinical global impression of change. The study was performed at six Centers of Excellence across the United States, including Neurology Center of New England in Foxboro (MA), the Shepherd Center in Atlanta (GA), Montefiore Medical Center ('Montefiore') in NY (NY), Oregon Health & Science University ('OHSU') in Portland (OR), MGH Institute of Health Professions in Boston (MA), NYU Langone Health in NY (NY), and recruited 43 MS participants with gait deficit. 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 future presentation and uses of the PoNSTEP study results 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 Taylor Gilmartin Groupinvestorrelations@
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
Associated Press
11-03-2025
- Business
- Associated Press
Helius Medical Technologies, Inc. Announces First Reimbursement by A Major Healthcare Provider for its Portable Neuromodulation Stimulator (PoNS®) Device
--Anthem Blue Cross Blue Shield approves claim for PoNS Device at out-of-network adjusted list price-- --Provides further validation of PoNS pricing-- NEWTOWN, Pa., March 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 its first reimbursement payment from a major healthcare provider, Anthem Blue Cross Blue Shield, for its PoNS Device. 'The first reimbursement from a commercial healthcare provider is a significant achievement for Helius and MS patients. The payment at out-of-network adjusted list price further validates the therapeutic benefit of PoNS and its economic value for payers,' said Dane Andreeff, Helius President and Chief Executive Officer. 'This is an important milestone in the pursuit of third-party reimbursement and coverage and as we appeal the current CMS payment rates. We will remain steadfast in prioritizing increased patient access to support more MS patients and drive growth of the business.' 'Importantly, this was an out-of-network total lump sum reimbursement payment, which typically is 30 to 40% below in-network contracted payment rates. Therefore, we believe this reimbursement payment, including patient co-payment, of $15,420 for the PoNS controller and mouthpiece establishes an important benchmark as we approach major commercial insurance carriers to negotiate reimbursement payment rates for PoNS,' concluded Andreeff. 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 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 the appeal of CMS payment rates; the pursuit of third party reimbursement and coverage; . 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 Taylor
