NEWTOWN, Pa., July 09, 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 July 7, 2025, Helius received formal notice from the Nasdaq Hearings Panel of the Nasdaq Stock Market LLC (the “Panel”) indicating that Helius has evidenced compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) f ...

U.S. stock futures were mixed this morning, with the Dow futures falling around 0.1% on Tuesday.Shares of Helius Medical Technologies, Inc. HSDT fell sharply in today's pre-market trading.Helius Medical Technologies filed prospectus for $25 million share offering.Helius Medical Technologies shares dipped 10.9% to $8.42 in the pre-market trading session.Here are some other stocks moving lower in pre-market trading.Blue Gold Limited BGL shares tumbled 15.6% to $63.00 in pre-market trading after dipping 30% on ...

Core Insights - The PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates long-term benefits of PoNS Therapy for gait deficits in individuals with Multiple Sclerosis (MS) [1][2] - The study results were presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, highlighting the importance of treatment adherence for achieving clinically meaningful improvements [2][3] Study Details - The PoNSTEP study is an open-label, observational, interventional multi-center research study assessing adherence to PoNS Therapy for gait deficits in MS patients [5] - The study involved 43 MS participants and was conducted at six Centers of Excellence across the United States [5] - The primary endpoint is the maintenance of gait improvement from the end of supervised therapy to the end of unsupervised therapy, with secondary endpoints including maintenance of improvement over six months [5] Treatment and Mechanism - PoNS Therapy combines the Portable Neuromodulation Stimulator (PoNS) device with physical therapy, applied for 100-120 minutes per day [5][7] - The PoNS device delivers mild electrical impulses to the tongue and is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms [7][8] Clinical Impact and Recognition - The study provides the first clinical trial evidence of PoNS Therapy's long-term benefits for functional rehabilitation in the MS population [3] - There is growing recognition of PoNS Therapy's direct effect on the central nervous system and its targeted mechanism of action compared to other interventions [3] Reimbursement and Access - Helius Medical Technologies has successfully obtained initial reimbursement from federal and private payers, which is expected to lower barriers to prescribing PoNS Therapy [4] - The company is actively engaging with health insurance providers to expand access to PoNS Therapy for all individuals with MS [3][4]

-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 def ...

Core Viewpoint - Helius Medical Technologies, Inc. has announced a public offering of 2,768,600 shares of Class A common stock and accompanying warrants, priced at $3.27 per share, aiming to raise approximately $9.1 million in gross proceeds before expenses [1][3]. Group 1: Offering Details - The public offering includes 2,768,600 shares of Class A common stock and warrants to purchase an equal number of shares at a combined price of $3.27 per share [1]. - Each warrant will expire in 2.5 years from issuance, is immediately exercisable at an initial price of $7.3575 per share, and can be exchanged for 2.0 common shares under a zero cash exercise option [2]. - The offering is expected to close on June 6, 2025, subject to customary closing conditions [3]. Group 2: Regulatory and Contact Information - A registration statement on Form S-1 was filed with the SEC and declared effective on June 4, 2025, with a final prospectus to be available on the SEC's website [4]. - Electronic copies of the prospectus can be obtained from Maxim Group LLC, the sole placement agent for the offering [4][7].

Core Points - Helius Medical Technologies has demonstrated full compliance with Nasdaq's minimum bid price requirement as of June 3, 2025 [1] - The company is required to regain compliance with the equity requirement by June 30, 2025, as per the extension granted by the Nasdaq Hearings Panel [2] - Helius Medical Technologies focuses on neurologic deficits through its Portable Neuromodulation Stimulator (PoNS) product [3]

Core Insights - Helius Medical Technologies, Inc. will present the final results of the PoNSTEP study, which confirms the efficacy of the Portable Neuromodulation Stimulator (PoNS) device for improving gait in individuals with multiple sclerosis (MS) [1][2] - The study highlights a statistically significant relationship between adherence to PoNS therapy and improvement in gait, indicating that consistent use leads to sustained benefits [3][4] Study Overview - The PoNSTEP study was a three-phase, real-world therapeutic experience designed to evaluate the impact of adherence on gait deficits and long-term outcomes in MS patients [3][8] - Participants underwent two weeks of supervised therapy, followed by 12 weeks of combined clinic and at-home use, concluding with a six-month follow-up to assess the durability of improvements [3][9] Key Findings - Stronger adherence to PoNS therapy resulted in better therapeutic outcomes, with highly adherent participants achieving over 6 points improvement in their Dynamic Gait Index (DGI) scores during the first 14 weeks [4][5] - More than 95% of participants maintained their level of improvement six months post-treatment, demonstrating the durability of the therapy's effects [5][7] Clinical Implications - The study provides evidence of the effectiveness of neuromodulation and neuroplasticity in rehabilitating gait deficits in MS patients, marking a significant advancement in treatment options for this population [7][10] - PoNS therapy is now accessible through insurance via the U.S. Department of Veterans Affairs and Department of Defense, with some commercial healthcare providers beginning to reimburse the device [7][12] About PoNS Device - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable device that delivers neurostimulation through a mouthpiece, used in conjunction with physical rehabilitation exercises to improve balance and gait in MS patients [12][14] - The device is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms and is prescribed for patients aged 22 and older [12][13]

Financial Performance - Total product sales decreased to $38 thousand in Q1 2025 from $124 thousand in Q1 2024, a decline of approximately 69%[96] - Gross loss for Q1 2025 was $72 thousand compared to a gross profit of $12 thousand in Q1 2024, reflecting a year-over-year variance of $84 thousand[99] - Selling, general and administrative expenses increased by $361 thousand to $2,994 thousand in Q1 2025 compared to Q1 2024[100] - Research and development expenses rose by $157 thousand to $945 thousand in Q1 2025, driven by increased product development costs[101] - The Company reported a net loss of $3.8 million for Q1 2025, compared to a net loss of $2.5 million in Q1 2024, indicating a year-over-year increase of 52%[96] - Cash and cash equivalents as of March 31, 2025, were $1,109 thousand, a slight increase from $1,088 thousand at the end of 2024[107] - The Company generated $3.4 million in net proceeds from warrant inducement offers during Q1 2025[116] Compliance and Regulatory Issues - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, with a closing bid price below $1.00 per share for 30 consecutive business days[72] - The company received a letter from Nasdaq indicating continued non-compliance with the minimum stockholders' equity requirement, as reported equity fell below $2.5 million[75] Product Development and Partnerships - The company announced its first reimbursement payment from Anthem Blue Cross Blue Shield for the PoNS Device on March 11, 2025[78] - The final payment rate for the PoNS Mouthpiece was set at $2,963.30 effective January 1, 2025, while the PoNS Controller was capped at $532.27[84] - The company partnered with Lovell Government Services to make the PoNS device available to federal healthcare systems, with prices set at $23,843.72 for the PoNS device and $7,344.97 for the mouthpiece[87] - The company established Revelation Neuro, Inc. to develop a new AI-powered brain-computer interface for personalized neurorehabilitation[86] - The company anticipates it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers following the effective date of HCPCS codes[85] - The company has established sales representative agreements to sell PoNS devices to Veterans Affairs facilities across various states[88] - The Company has been seeking a business partner to commercialize and distribute PoNS in Australia, where it is authorized for sale as a Class IIa medical device[69] - The Company enrolled 128 participants in its stroke registrational program by December 31, 2024, exceeding the initial target of 90[91] Strategic Initiatives - The Company plans to seek additional funding to support ongoing operations and clinical trials, indicating potential liquidity challenges[118] - The Company has initiated a process to explore strategic alternatives to maximize stockholder value, engaging B. Riley Securities as a financial advisor[92]

Core Viewpoint - Helius Medical Technologies, Inc. announced a 1-for-15 reverse stock split of its Class A common stock, effective May 1, 2025, to comply with Nasdaq listing requirements [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every 15 shares of common stock into one share, maintaining the par value at $0.001 and the authorized number of shares at 150 million [2][4]. - Following the reverse split, the number of outstanding shares will decrease from approximately 7.9 million to about 0.5 million [4]. - The reverse stock split will proportionately reduce the number of shares issuable upon conversion of stock options and warrants, increasing their conversion and exercise prices accordingly [3]. Group 2: Trading Information - The common stock will continue to trade on The Nasdaq Capital Market under the symbol "HSDT" with a new CUSIP number of 42328V 884 after the split [4]. - Any fractional shares resulting from the reverse split will be rounded down to the nearest whole share, with stockholders receiving cash for the market value of the fractional share [3]. Group 3: Company Overview - Helius Medical Technologies focuses on neurologic deficits through a novel therapeutic neuromodulation approach, with its first commercial product being the Portable Neuromodulation Stimulator (PoNS) [6].

Financial Performance - Total revenue decreased by $124,000, from $644,000 in 2023 to $520,000 in 2024, representing a decline of approximately 19.3%[374] - Net product sales in the U.S. dropped by $143,000, from $324,000 in 2023 to $181,000 in 2024, a decrease of about 44.1%[374] - Gross loss for 2024 was $62,000 compared to a gross profit of $61,000 in 2023, indicating a year-over-year variance of $123,000[378] - Total operating expenses increased by $1,352,000, from $12,489,000 in 2023 to $13,841,000 in 2024, an increase of approximately 10.8%[374] - Net loss for 2024 was $11,742,000, compared to a net loss of $8,850,000 in 2023, reflecting an increase in loss of $2,892,000[374] - Cash and cash equivalents decreased from $5,182,000 in 2023 to $1,088,000 in 2024, a decline of approximately 79.0%[388] - Net cash used in operating activities increased by $625,000, from $10,416,000 in 2023 to $11,041,000 in 2024[390] - The company expects to continue incurring significant expenses and operating losses for the foreseeable future, indicating substantial doubt about its ability to continue as a going concern[395] - The company does not currently have sufficient resources to achieve profitability and anticipates needing additional financing[408] - There is uncertainty regarding the availability of funding to meet required expenditures[408] Capital Raising and Financial Resources - The company generated gross proceeds of $3.7 million from warrant exercise inducement offer letters on January 21, 2025[351] - The company received net proceeds of approximately $5.5 million from a registered public offering of its Common Stock and warrants in May 2024[359] - The company raised $5.5 million in net proceeds from a public offering completed in May 2024[388] - The company plans to use available capital resources primarily to expand U.S. commercialization efforts and fund clinical trials[396] Product Development and Commercialization - The final payment rate for the PoNS Mouthpiece was set at $2,963.30 effective January 1, 2025, while the PoNS Controller was preliminarily priced at $532.27[357] - The company established Revelation Neuro on March 11, 2025, to develop a new AI-powered brain-computer interface for personalized neurorehabilitation[350] - The company completed enrollment of 128 participants for its stroke registrational program by December 31, 2024, exceeding the initial target of 90[366] - The company began commercial sales of the PoNS device in the U.S. in April 2022, following the acceptance of prescriptions in March 2022[346] - The company partnered with Lovell Government Services to make the PoNS device available to federal healthcare systems, with pricing set at $23,843.72 for the PoNS device[358] - The company anticipates it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers from the effective date of HCPCS codes[368] - The company is pursuing commercial insurance coverage for PoNS within the Durable Medical Equipment benefit category, with CMS assigning HCPCS Level II codes effective April 1, 2024[353] Compliance and Regulatory Matters - The company received a Notification Letter from Nasdaq on August 9, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share for 30 consecutive business days[348]