Latest news with #Helius'
Yahoo
12-06-2025
- Health
- Yahoo
Positive PoNSTEP Study Results Presented at Consortium of Multiple Sclerosis Centers Annual Meeting
-PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy® on gait deficit improvement in people with Multiple Sclerosis- -Presentation of full PoNSTEP study results expanded upon top line data previously reported- NEWTOWN, Pa., June 12, 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, today announced that Deborah Backus, PT, Ph.D., FACRM- Vice President of Research and Innovation at Atlanta's Shepard Center presented the positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting on May 29 in Pheonix, Arizona. Dr. Backus' presentation highlighted the importance of treatment adherence as a key requirement for achieving a clinically meaningful improvement in gait disability over 14 weeks of therapy and its sustained therapeutic effect well into 6 months after the end of treatment. The study results confirm controlled and real-world clinical evidence of PoNS Therapy's long-term benefits already reported in people with balance deficit due to traumatic brain injury (TBI). 'The results from this study were received with great interest as they provide the first clinical trial evidence of the long-term therapeutic benefits of PoNS Therapy for functional rehabilitation in the MS population,' stated Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. 'We were excited to engage with both US healthcare professionals and Canadian MS specialists and offer additional insights on the body of clinical and mechanistic evidence of PoNS Therapy's effect in MS. We are encouraged by the growing recognition of the importance of PoNS' direct effect on the central nervous system and its targeted mechanism of action as well as how it correlates with a lasting and sustained effect on gait rehabilitation, especially when comparing PoNS Therapy to other interventions limited to peripheral neuromuscular or transcutaneous stimulation.' CMSC attendees were encouraged at Helius' recent successes in obtaining initial reimbursement from federal and private payers and appreciated the Company's relentless effort to engage with health insurance providers, viewing it as a much-needed endeavor to expand access to PoNS Therapy to all people with MS. 'We are excited by the positive conversations had at CMSC regarding both the therapeutic impact of the data presented and the recent announcement of reimbursement from the VA and out of network commercial payers for PoNS,' stated Dane Andreeff, Helius' President and Chief Executive Officer. 'We anticipate that the increase in reimbursement coverage will significantly lower the barrier to prescribe PoNS and allow for greater access to this important therapy.' About PoNS Therapeutic Experience Program (PoNSTEP) The PoNS Therapeutic Experience Program ('PoNSTEP') 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, the availability of commercial reimbursement 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 Error in retrieving data Error in retrieving data Error in retrieving data
Hamilton Spectator
12-06-2025
- Health
- Hamilton Spectator
Positive PoNSTEP Study Results Presented at Consortium of Multiple Sclerosis Centers Annual Meeting
-PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy® on gait deficit improvement in people with Multiple Sclerosis- -Presentation of full PoNSTEP study results expanded upon top line data previously reported- NEWTOWN, Pa., June 12, 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, today announced that Deborah Backus, PT, Ph.D., FACRM- Vice President of Research and Innovation at Atlanta's Shepard Center presented the positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting on May 29 in Pheonix, Arizona. Dr. Backus' presentation highlighted the importance of treatment adherence as a key requirement for achieving a clinically meaningful improvement in gait disability over 14 weeks of therapy and its sustained therapeutic effect well into 6 months after the end of treatment. The study results confirm controlled and real-world clinical evidence of PoNS Therapy's long-term benefits already reported in people with balance deficit due to traumatic brain injury (TBI). 'The results from this study were received with great interest as they provide the first clinical trial evidence of the long-term therapeutic benefits of PoNS Therapy for functional rehabilitation in the MS population,' stated Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. 'We were excited to engage with both US healthcare professionals and Canadian MS specialists and offer additional insights on the body of clinical and mechanistic evidence of PoNS Therapy's effect in MS. We are encouraged by the growing recognition of the importance of PoNS' direct effect on the central nervous system and its targeted mechanism of action as well as how it correlates with a lasting and sustained effect on gait rehabilitation, especially when comparing PoNS Therapy to other interventions limited to peripheral neuromuscular or transcutaneous stimulation.' CMSC attendees were encouraged at Helius' recent successes in obtaining initial reimbursement from federal and private payers and appreciated the Company's relentless effort to engage with health insurance providers, viewing it as a much-needed endeavor to expand access to PoNS Therapy to all people with MS. 'We are excited by the positive conversations had at CMSC regarding both the therapeutic impact of the data presented and the recent announcement of reimbursement from the VA and out of network commercial payers for PoNS,' stated Dane Andreeff, Helius' President and Chief Executive Officer. 'We anticipate that the increase in reimbursement coverage will significantly lower the barrier to prescribe PoNS and allow for greater access to this important therapy.' About PoNS Therapeutic Experience Program (PoNSTEP) The PoNS Therapeutic Experience Program ('PoNSTEP') 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, the availability of commercial reimbursement 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 Group investorrelations@
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
Cision Canada
09-05-2025
- Business
- Cision Canada
Helius' Transaction with Colossus on Serra Pelada Project Receives Colossus Shareholder Approval
VANCOUVER BC, May 9, 2025 /CNW/ - Helius Minerals Limited (" Helius" or the " Company") (TSXV: HHH) is pleased to announce that the shareholders of Colossus Minerals Inc. (" Colossus") at the special meeting of Colossus' shareholders held on May 2, 2025 passed a special resolution approving the sale to Helius of all of the shares (the " Target Companies' Shares") of Colossus Mineracao Ltda. (" Colossus Brazil") and Mineracao Fazenda Monte Belo Ltda. (" MFM", and together with Colossus Brazil, the " Target Companies"), representing all or substantially all of the property of Colossus, and thereby a 75% beneficial interest in the partnership called Serra Pelada – Companhia de Desenvolvimento Mineral (" SPCDM"), which partnership holds a 100% interest in the Serra Pelada gold-platinum-palladium mining project in Brazil (the " Serra Pelada Project"). Colossus became insolvent in 2014 after dewatering measures at the Serra Pelada Project proved inadequate in controlling water ingress. This created liquidity issues immediately before metal production was to commence, which led to Colossus' bankruptcy. The Serra Pelada Project was thereafter put on a care and maintenance program and Colossus halted all exploration, construction and development activities to conserve cash. As announced in Helius' news releases of March 4, 2025 and March 25, 2025, Helius entered into a definitive Exclusivity, Share Option and Acquisition Agreement dated March 3, 2025 (the " Definitive Agreement") with Colossus which provides Helius with a twelve-month exclusivity period to conduct financing (the " Financing") to undertake: (a) a review and development of a plan to ensure compliance with relevant mining laws and other regulatory requirements; (b) the formulation of a comprehensive strategy to address outstanding debts, including those related to ongoing litigation, of the Target Companies; and (c) the development of a detailed plan to rehabilitate the Serra Pelada Project, the Target Companies and SPCDM (collectively, the " Organizational Period Requirements"), to allow Helius to address certain regulatory and compliance matters to allow the Serra Pelada Project to move forward. As announced in Helius' news release dated April 11, 2025, Helius completed the Financing on April 10, 2025 by closing a non-brokered private placement of 4,300,000 common shares of the Company at a price of Cdn$0.50 per share to raise gross proceeds of $2,150,000. Upon Helius' satisfaction of the Organizational Period Requirements, and upon receipt of conditional approval from the TSX Venture Exchange, Helius could elect, in its sole discretion, to deliver notice (the " Option Notice") to Colossus of its decision to proceed with an irrevocable option (the " Option") to purchase: (a) all of the shares of the Target Companies' Shares; and (b) all of the intercorporate loans and all interest accrued thereunder (the " Intercompany Debt") owed by the Target Companies to Colossus, if any. Upon Helius' exercise of the Option within six months of the date of delivery of the Option Notice, the parties would proceed with closing of Helius' purchase of the Target Companies' Shares and any Intercompany Debt. Helius is also pleased to announce that it has received approval from the holders of the existing senior secured convertible notes issued by Colossus (the " Existing Notes") in an aggregate principal amount of US$4 million (the " Existing Debt") to exchange said Existing Notes for amended senior secured convertible notes that Helius would issue to said noteholders in exchange for the Existing Debt. In addition, Helius is also pleased to announce that Christian Grainger, Evan Jones, Brian Cole and Samuel Clarke were elected to its board of directors at its annual general meeting of shareholders held April 29, 2025. Samuel Clarke is a new director and his appointment is subject to TSX Venture approval. Mr. Clarke has 20 years of mining executive experience, including roles as Finance Director or Chief Financial Officer at various public mining companies, and he is a Chartered Accountant. Helius' focus will now shift to completing certain due diligence on the Serra Pelada Project to satisfy the Organizational Period Requirements with a view to potentially exercising the Option to acquire the Target Companies' Shares and any Intercompany Debt. About Helius Minerals Limited Helius is a mineral exploration company focused on the identification and exploration of high-quality mineral assets across the Americas, with an emphasis on South American jurisdictions. On Behalf of the Board of Directors of Helius Minerals Limited Neither TSX Venture Exchange nor its Regulation Services Provider (as that term in defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS: This news release may contain forward-looking information within the meaning of applicable securities laws ("forward-looking statements"). Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," 'projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur. Forward-looking statements in this news release include, without limitation, statements regarding the acquisition in connection with Serra Pelada Project and Target Companies and the future satisfaction of the Organizational Period Requirements . These forward-looking statements are subject to a variety of risks and uncertainties which could cause actual events or results to differ materially from those reflected in the forward-looking statements, including, without limitation: the uncertainties inherent to current and future legal challenges that face the Serra Pelada Project and the Target Companies; controls, regulations, and political or economic developments in Brazil; changes in national and local government legislation in Canada and Brazil; the lack of certainty with respect to foreign legal systems, which may not be immune from the influence of political pressure, corruption or other factors that are inconsistent with the rule of law; the speculative nature of mineral exploration and development, including the risks of obtaining and maintaining the validity and enforceability of the necessary licenses and permits and complying with the permitting requirements of Brazil; fluctuations in the international currency markets and in the rates of exchange of the currencies of Canada, the United States and Brazil; significant capital requirements; risks related to fluctuations in metal prices; uncertainties related to raising sufficient financing to fund exploration work in a timely manner and on acceptable terms; changes in planned work resulting from weather, logistical, technical or other factors; the possibility that results of work will not fulfill expectations and realize the perceived potential of the Serra Pelada Project; risk of accidents, equipment breakdowns and labour disputes or other unanticipated difficulties or interruptions; the possibility of cost overruns or unanticipated expenses in conducting work programs; the risk of environmental contamination or damage resulting from Helius' operations and other risks and uncertainties. Any forward-looking statement speaks only as of the date it is made and, except as may be required by applicable securities laws, the Company disclaims any intent or obligation to update any forward-looking statement, whether as a result of new information, future events or results or otherwise.
