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 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 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]

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 ...

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 ...