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].

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 neuro ...

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]

Core Insights - Helius Medical Technologies, Inc. has established a wholly-owned subsidiary, Revelation Neuro, Inc., to develop non-implantable AI-powered brain-computer interface (BCI) technology aimed at enhancing neurorehabilitation [1][2][3] - The new technology will utilize Helius' existing intellectual property (IP) and a dataset of over 5 years of clinical evidence from more than 400 subjects to optimize therapeutic responses through translingual stimulation [3] - Helius plans to present at the 37th Annual Roth Conference on March 17, 2025, to discuss its advancements and future plans [4] Company Overview - Helius Medical Technologies focuses on neurologic deficits and aims to improve the lives of individuals with neurologic diseases through its innovative neuromodulation technology [5] - The company's first commercial product is the Portable Neuromodulation Stimulator (PoNS®), which enhances the brain's ability to engage compensatory mechanisms and promote neuroplasticity [5] Revelation Neuro's Objectives - Revelation Neuro aims to create a new standard of care for personalized neurorehabilitation by combining newly developed IP with Helius' existing IP [2] - The subsidiary will focus on maximizing the effects of neuromodulation by applying AI to tailor individual responses to treatment [3] - Future applications may extend to addressing neurological conditions such as cognitive deficits and mood disorders [3] Financial Strategy - Helius has invested over $70 million in developing its neuromodulation technology and data collection, which will support the rapid development of Revelation Neuro's AI-powered BCI [3] - The company does not plan to invest significant additional capital into Revelation Neuro but expects it to be financed through third-party sources [3]

Core Insights - Helius Medical Technologies, Inc. has established a wholly-owned subsidiary, Revelation Neuro, Inc., to develop non-implantable AI-powered brain-computer interface (BCI) technology aimed at improving neurorehabilitation [1][2][3] - The new technology will utilize Helius' existing intellectual property (IP) and a dataset of over 5 years of clinical evidence from more than 400 subjects to optimize therapeutic responses [3] - Helius plans to present at the 37th Annual Roth Conference on March 17, 2025, to discuss its advancements and future plans [4] 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) [5] - The company has invested over $70 million in developing its proprietary neuromodulation mechanism and data gathering, which will support the rapid development of Revelation Neuro's AI-powered BCI [3] Technology Development - Revelation Neuro aims to create a new standard of care for personalized neurorehabilitation by combining newly developed IP with Helius' existing IP, utilizing translingual stimulation to modulate brain processes without the need for implantation [2][3] - The focus will initially be on functional rehabilitation, with future potential applications in addressing cognitive deficits and mood disorders [3]

Core Insights - Helius Medical Technologies, Inc. has received its first reimbursement payment for the PoNS Device from Anthem Blue Cross Blue Shield, marking a significant milestone for the company and multiple sclerosis (MS) patients [1][2] - The reimbursement payment of $15,420 for the PoNS controller and mouthpiece is based on an out-of-network adjusted list price, which is typically 30 to 40% lower than in-network contracted rates, establishing a benchmark for future negotiations with commercial insurance carriers [2] Company Overview - Helius Medical Technologies is a neurotech company focused on addressing neurologic deficits through its Portable Neuromodulation Stimulator (PoNS), which enhances the brain's ability to engage compensatory mechanisms and promote neuroplasticity [3] - The PoNS Device is a non-implantable therapy that delivers neurostimulation via a mouthpiece, primarily used at home alongside physical rehabilitation exercises to improve balance and gait in patients aged 22 and over with MS [4] Product Efficacy - The PoNS Device has demonstrated effectiveness in treating gait and balance deficits, significantly reducing the risk of falls in stroke patients, and is authorized for use in Canada and Australia for various indications related to stroke and traumatic brain injury [5]

Core Insights - The PoNS Therapeutic Experience Program (PoNSTEP) study shows long-term beneficial effects of PoNS Therapy on gait deficits in individuals with Multiple Sclerosis (MS) [1][2][5] - Statistically significant improvements in the Dynamic Gait Index (DGI) were observed, with a total mean improvement of 5.00 (from 4.1 to 5.9, p<0.001) at week 14 among participants who completed the treatment [1][6] Study Overview - The study involved 43 patients with mild-to-moderate MS, focusing on gait deficits, and included 14 weeks of rehabilitation with PoNS Therapy [3][9] - The treatment protocol consisted of 2 weeks in a clinical setting (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month observation period (Phase 3) [3][7] Results and Findings - Of the 41 patients who started the study, 38 completed it, and 29 were evaluated at the 6-month mark [3][6] - The average adherence to therapy was 71% in Phase 2, with a linear association between adherence and gait improvement (r=0.345; p=0.034) [6] - In Phase 1, adherence was 89.5%, but it did not correlate with improvement [6] - Participants with ≥85% adherence in Phase 2 showed a mean improvement of 3.7 points in DGI, while those with <85% adherence improved by 2.0 points, with a statistically significant difference (p=0.008) [6] Long-term Effects - At the 6-month follow-up, only 1 out of 28 participants showed a decline of ≥30% in DGI [6] - The mean decline in DGI was -4.1%, with a 95% confidence interval indicating that the true mean decline was no more than -9.4% (p=0.12) [6] Implications for Therapy - The study reinforces the efficacy of PoNS Therapy in improving gait deficits due to MS and highlights the importance of treatment compliance for achieving lasting therapeutic benefits [2][5] - The findings contribute to understanding the role of neuromodulation and neuroplasticity in rehabilitation for gait function [2][5]