-- Inclusion of the top neurorehabilitation centers REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions completes site participation enrollment for the U.S. registrational program in stroke -- "PoNS Therapy has demonstrated the ability to generate neuroplasticity, essentially rewiring parts of the brain to significantly and meaningfully improve gait and balance in chronic stroke survivors. With the addition of REHABOLOGYM, NCNE, and MGH-IHP, we now have five of the top neur ...

The registrational program was established in part based on real-world evidence from Canada, where PoNS is already authorized for treatment of stroke. To support national reimbursement in Canada, Helius has begun an additional study on the use of PoNS Therapy to treat stroke, with the goal of enrolling 60 subjects by the end of 2024 at three centers of excellence for stroke rehabilitation. The study led by Dr. Murielle Grangeon, PhD, Adm., Founder and General Manager, at Neuro-Concept Rehabilitation Center, ...

-- Reimbursement at $23,900, slightly below list price -- -- Represents a significant milestone toward increasing accessibility of PoNS -- NEWTOWN, Pa., May 29, 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 third-party reimbursement from a major insurance carrier for the Company's Portable Neuromodulation Stimu ...

NEWTOWN, Pa., May 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, will exhibit for the third consecutive year at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, where it will spotlight a year of significant progress in making its innovative Portable Neuromodulation Stimulator (PoNS®) more accessible to people whos ...

NEWTOWN, Pa., May 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, will exhibit for the third consecutive year at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, where it will spotlight a year of significant progress in making its innovative Portable Neuromodulation Stimulator (PoNS®) more accessible to people whos ...

Core Insights - Helius Medical Technologies has received approval for its Portable Neuromodulation Stimulator (PoNS®) device to be included in the Veterans Affairs (VA) Federal Supply Schedule and GSA Advantage contracts, providing access to U.S. veterans and government employees suffering from gait and balance impairments due to multiple sclerosis (MS) [1][4] Product and Pricing - The PoNS system is priced at $23,843.72, while the PoNS mouthpiece costs $7,344.97, and it is indicated for short-term treatment of gait deficits in adults with mild-to-moderate MS symptoms when used alongside physical therapy [2] - The device is designed to deliver neurostimulation through a mouthpiece and is primarily used at home in conjunction with physical rehabilitation exercises [7] Market Potential - The VA estimates that between 55,000 and 70,000 veterans in the U.S. are living with MS, indicating a significant potential market for the PoNS device [3] - The inclusion of PoNS on the FSS Med/Surg and GSA Advantage marketplace is expected to facilitate quicker access to this therapy for veterans and federal employees [4] Company Background - Helius Medical Technologies focuses on neurologic deficits and aims to improve the lives of individuals dealing with neurologic diseases through its innovative technology platform [6] - Lovell Government Services, a partner of Helius, has a strong track record in introducing suppliers to the government market and aims to enhance federal revenue streams for medical and pharmaceutical companies [5]

Financial Data and Key Metrics Changes - Total revenue for Q1 2024 was $135,000, an increase of $24,000 compared to $111,000 in Q1 2023, reflecting increased product sales in both the U.S. and Canada [12] - Cost of revenue remained relatively flat at $123,000 in Q1 2024 compared to $122,000 in the prior year [12] - Operating loss for Q1 2024 was $3.4 million, compared to a loss of $3.8 million in the prior year [41] - Net loss for Q1 2024 was $2.5 million, or a loss of $3.08 per share, compared to a net loss of $2.5 million, or a loss of $4.42 per share in the prior year [41] - Cash burn from operations decreased to $3 million in Q1 2024 from $3.2 million in Q1 2023 [41] - As of March 30, 2024, the company had $3.6 million in cash and no debt [41] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $0.8 million in Q1 2024 from $0.9 million in Q1 2023, primarily due to a decrease in product development expenses and clinical trial activities [25] - Selling, general and administrative expenses decreased to $2.6 million in Q1 2024 from $2.9 million in Q1 2023, mainly due to a decrease in professional fees and payroll-related expenses [40] Market Data and Key Metrics Changes - The company is targeting regulatory submission by early 2025 for stroke treatment, with a goal of receiving marketing authorization later in the year [52] - The preliminary Medicare payment determinations for the PoNS controller and mouthpiece were released, with a public meeting scheduled for May 29, 2024 [20] Company Strategy and Development Direction - The company is focused on securing widespread reimbursement for PoNS and achieving FDA approval for stroke, with both goals in sight [4][11] - The partnership with Global Government Services aims to make PoNS available to federal healthcare systems, enhancing access for veterans suffering from MS [10] - The company is working to establish sites in Canada as part of a government-funded initiative to validate the effectiveness of PoNS therapy for stroke [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving CMS reimbursement as early as October 1, 2024, which would significantly boost revenues and provide a pathway to positive cash flow [11][42] - The company highlighted the importance of engaging with the physical therapy community to facilitate the adoption of PoNS therapy [24] Other Important Information - The company closed a $6.4 million public offering, extending its cash runway into 2025 [26] - The company is in the process of having PoNS Therapy contracted with the FSS and GSA, with expectations to start receiving prescriptions in early June 2024 [28][31] Q&A Session Summary Question: Can you provide an update on the timeline with the Lovel Government Services agreement? - Management indicated that they are in the process of finalizing the agreement and expect to start receiving prescriptions soon, with training for VA rehab experts ongoing [28][31] Question: What demand have you seen from new physical therapists taking the training program for PoNS Therapy? - Management noted that there has been steady and increasing interest from physical therapists, particularly in Canada, as they aim to fill in the map with registered PoNS trainers [35][36]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) | Delaware | 36-4787690 | | - ...

Exhibit 99.1 Helius Medical Technologies, Inc. Reports First Quarter 2024 Financial Results ● Received Healthcare Common Procedure Coding System ("HCPCS") codes and preliminary determination for reimbursement for the Portable Neuromodulation Stimulator ("PoNS®") mouthpiece and controller from the Centers for Medicare & Medicaid Services ("CMS"), paving the way toward final price determination on October 1, 2024. ● Added six more sites to the stroke registrational program in the U.S. and Canada; reached alig ...

NEWTOWN, Pa., May 10, 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 first quarter 2024 financial results on Monday, May 13, 2024, after the market closes. Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer will host a conference cal ...