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]

Transaction Details - Helius Medical Technologies has entered into agreements with certain warrant holders to exercise outstanding warrants for 4,971,110 shares of common stock at a reduced exercise price of $0.751 per share, generating approximately $3.7 million in gross proceeds [1] - The new warrants will be exercisable for up to 6,213,888 shares of common stock, with 3,728,333 warrants exercisable for five years and 2,485,555 warrants exercisable for two years after stockholder approval [3] - Roth Capital Partners is acting as the financial advisor for this transaction [2] PoNS Device and Therapy - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece to improve balance and gait, primarily used at home with physical rehabilitation exercises [5] - PoNS is indicated in the US for short-term treatment of gait deficit due to mild-to-moderate multiple sclerosis symptoms and is used as an adjunct to supervised therapeutic exercise programs for patients aged 22 and over [5] - In Canada, PoNS is authorized for sale in three indications: gait deficit due to stroke, chronic balance deficit due to mild-to-moderate traumatic brain injury, and gait deficit due to multiple sclerosis, all used in conjunction with physical therapy [6] - PoNS is also authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to therapeutic exercise programs to improve balance and gait [6] Company Overview - Helius Medical Technologies is a leading neurotech company focused on neurologic deficits using an orally applied technology platform that amplifies the brain's ability to engage physiologic compensatory mechanisms and promote neuroplasticity [7] - The company's first commercial product is the Portable Neuromodulation Stimulator (PoNS) [8]

--128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants-- --150 maximum participant enrollment projected by end of January-- --The stroke registrational program is intended to demonstrate the safety and effectiveness of the novel Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors-- --On track for FDA submission for stroke authorization in the second quarter of 2025-- NEWTOWN, Pa., Jan. 21, 2025 (GLOBE NEWSWIRE) -- H ...

NEWTOWN, Pa., Dec. 23, 2024 (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 the first PoNS System sale to the VA Healthcare System. The PoNS System sale through our distributor, Lovell Government Services ("Lovell"), was at the contracted price of $23,844, comprised of $16,499 for the PoNS Controller and $7,345 for the PoNS Mou ...

NEWTOWN, Pa., Nov. 18, 2024 (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 provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator (PoNS) device and announced plans to host a business update call today at 9:00am ET.   “We disagree with the proposed pricing for the PoNS Mouthpiece and are ...

Helius Medical Technologies, Inc. to Present at the 2024 ThinkEquity Conference NEWTOWN, Pa., Oct. 18, 2024 – PRISM MediaWire – Helius Medical Technologies, Inc. ("Helius" or the "Company") [Nasdaq: HSDT], a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that it plans to participate in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institutional ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $182,000, a decrease of $74,000 compared to $256,000 in Q2 2023, primarily due to the termination of the Patient Therapy Access Program and temporary cash pay pricing [9] - Revenue increased by 35% compared to Q1 2024, attributed to higher sales in both the US and Canada [9] - Operating loss for Q2 2024 was $3.2 million, consistent with the loss reported in the prior year [9][10] - Net loss for Q2 2024 was $1.6 million, or a loss of $0.64 per share, compared to a net loss of $1.6 million or a loss of $2.92 per share in the prior year [10] Business Line Data and Key Metrics Changes - The company focused on increasing access to PoNS therapy for MS patients, resulting in significant momentum toward greater access [3] - The partnership with Lovell Government Services aimed to make PoNS therapy accessible to veterans, with pricing established for the PoNS device and mouthpiece [4][5] - The company reported the first third-party reimbursement of $23,900 for a PoNS device, indicating progress in reimbursement efforts [4] Market Data and Key Metrics Changes - The VA estimates that between 65,000 and 70,000 veterans in the US live with MS, representing a significant market opportunity for PoNS therapy [4] - The company is actively building a sales representative organization to service VA sites across 13 states, which is critical for expanding sales [6] Company Strategy and Development Direction - The company aims to remove barriers to access and secure reimbursement for PoNS therapy, with a focus on stroke authorization in the US [7] - A registrational program for stroke has been fully enrolled, with expectations to submit for FDA approval in 2025 [7][8] - The company is also expanding its research efforts in Canada to support national reimbursement and strengthen its data package for FDA submission [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the expected Medicare reimbursement effective October 1, 2024, which is anticipated to significantly boost revenues [10] - The company has a strong list of Medicare patients awaiting reimbursement, indicating built-up demand [12] - Management is on track with patient enrollment for the stroke trial and plans to submit to the FDA in the first half of 2025 [13] Other Important Information - The company closed a $6.4 million public offering in May, extending its cash runway into 2025 [10] - The expected final determination from CMS regarding reimbursement rates is anticipated to be announced in late summer [10] Q&A Session Summary Question: What is the pipeline of patients once the final price determination is received from CMS? - The company has maintained a list of Medicare patients and their prescribers, indicating strong built-up demand for reimbursement [12] Question: Where is the company with patient enrollment for the stroke trial? - The company is on track with enrollment and plans to submit to the FDA in the first half of 2025, utilizing its second FDA breakthrough designation [13] Question: What is the status of potential studies or expansion for TBI? - The company is investigating expansion into TBI, with previous studies showing significant cost benefits associated with PoNS therapy for TBI patients [14]

NEWTOWN, Pa., Aug. 12, 2024 (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 results for the quarter ended June 30, 2024. Second Quarter and Recent Business Updates Secured the first third-party reimbursement for the Portable Neuromodulation Stimulator ("PoNS®") device from a major insurance carrier at $23,900, representing a si ...

NEWTOWN, Pa., Aug. 06, 2024 (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 the Company will release its second quarter 2024 financial results on Monday, August 12, 2024, after the market closes. Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer will host a conferen ...

NEWTOWN, Pa., Aug. 06, 2024 (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 the Company will release its second quarter 2024 financial results on Monday, August 12, 2024, after the market closes. Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer will host a conferen ...