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Helius Med Technologies Inc - HSDT STOCK NEWS

Welcome to our dedicated page for Helius Med Technologies news (Ticker: HSDT), a resource for investors and traders seeking the latest updates and insights on Helius Med Technologies stock.

Overview

Helius Medical Technologies Inc (Nasdaq: HSDT) is a specialized neurotechnology company dedicated to addressing neurological deficits through innovative, non-invasive solutions. With a core focus on neuromodulation and neurostimulation, Helius leverages its proprietary technology to promote neuroplasticity—the brain's capacity to adapt and rewire—in order to improve gait, balance, and motor functions in individuals affected by neurological trauma and disease.

Core Technology and Therapeutic Approach

The company’s flagship product, the Portable Neuromodulation Stimulator (PoNS), is a medical device that delivers mild electrical impulses via a tongue-placed mouthpiece. This unique mode of delivery is designed to activate cranial nerves and stimulate neural pathways, facilitating physiologic compensatory mechanisms. The therapeutic approach is used primarily in conjunction with supervised rehabilitation, merging physical therapy with targeted neuromodulation to restore lost function and improve overall mobility in patients coping with conditions such as multiple sclerosis, mild-to-moderate traumatic brain injury, and stroke-induced gait deficits.

Clinical Applications and Market Position

Helius Medical Technologies stands at the intersection of advanced clinical neuroscience and practical medical technology. Its technology is underpinned by robust clinical research and regulatory milestones, demonstrating significant improvements in balance and gait through measurable neuroplastic changes. The company has navigated complex reimbursement landscapes and regulatory frameworks in key markets, ensuring that its therapeutic solutions are accessible for patient populations in both Canada and the United States.

Business Model and Revenue Generation

Helius employs a multifaceted business model focused on development, licensing, and strategic acquisitions. Revenue generation primarily stems from the commercialization of its PoNS device, which is integrated within existing medical and therapeutic frameworks. The company’s approach involves building partnerships with federal healthcare systems, such as the Veterans Administration, and negotiating reimbursement arrangements with third-party payers. This model aligns technical innovation with market access initiatives, targeting a well-defined niche in the neurological rehabilitation market.

Strategic Collaborations and Industry Impact

Through strategic collaborations with clinical research centers and governmental contracting entities, Helius Medical Technologies has established critical validation of its technology with real-world applications. The integration of PoNS into prominent clinical trials and its inclusion on federal supply schedules underscore the company’s commitment to addressing unmet patient needs in neurorehabilitation. Moreover, its work in achieving reimbursement from major insurers further solidifies its role as a pivotal player in the neurotechnology space.

Research, Development, and Regulatory Engagement

The company has consistently demonstrated its commitment to research and development, investing significantly in studies that underscore its technology’s efficacy. Ongoing clinical registrational programs including those focused on stroke recovery exemplify the company’s dedication to gathering comprehensive clinical data. Regulatory engagement continues to be a cornerstone of its strategy as it works closely with agencies to secure approvals and reimbursement adjustments, which are essential for widespread clinical adoption.

Market Significance and Competitive Landscape

Operating in the highly specialized field of neurotechnology, Helius Medical Technologies distinguishes itself by targeting therapeutics that facilitate neuroplasticity—a key differentiator that underpins its market positioning. By addressing critical symptoms associated with neurological impairments through a non-invasive, easily accessible device, Helius satisfies a crucial need within the broader healthcare ecosystem. Its competitive edge is maintained through continuous research, strategic partnerships, and a clear focus on providing tangible improvements in patient mobility and quality of life.

Conclusion

Helius Medical Technologies Inc embodies innovation in neurotech, blending advanced scientific concepts with practical applications to offer a transformative therapeutic modality for patients suffering from neurological deficits. The company’s dedication to neuromodulation through its PoNS device, comprehensive clinical validation, and proactive engagement with regulatory bodies collectively establish it as a noteworthy entity in the field of medical devices and neurological rehabilitation.

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Helius Medical Technologies, Inc. announces FDA interaction and clinical program optimization for PoNS Therapy in stroke patients. The company aims to evaluate non-invasive neuromodulation for gait and balance deficits, targeting regulatory submission and marketing authorization by 2025. Real-world evidence demonstrates significant improvement in gait and balance, positioning the company for potential breakthrough designation for stroke.
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Helius Medical Technologies, Inc. expands its presence at the 2024 American Physical Therapy Association (APTA) Combined Sections Meeting to showcase its Portable Neuromodulation Stimulator (PoNS®) and highlight the role of physical therapists in using the therapy to improve gait in people with multiple sclerosis (MS). PoNS-trained physical therapists are now present in 10 states across the US, including those with the highest MS prevalence such as New York, California, and Florida.
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Helius Medical Technologies, Inc. (HSDT) expands registrational program for PoNS Therapy™ with the addition of Brooks Rehabilitation Hospital, bringing the total number of patients to 100. The study focuses on evaluating cranial-nerve non-invasive neuromodulation for gait/balance deficits in chronic stroke survivors, with the goal of achieving U.S. authorization under PoNS’s breakthrough designation for stroke.
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Helius Medical Technologies, Inc. (HSDT) to present at NobleCon 19th Annual Emerging Growth Equity Conference. President and CEO Dane Andreeff to discuss novel therapeutic neuromodulation approach for balance and gait deficits.
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Helius Medical Technologies, Inc. (Nasdaq:HSDT) announces Q3 2023 results, with $143 thousand in revenue, a decrease from Q3 2022, and operating cash burn of $2.5 million. The company extended its cash runway into Q2 2024, and received UPC numbers for the PoNS system and mouthpiece, allowing for dual paths of reimbursement. A letter of intent from the Québec Ministry of Health and Social Services for the purchase of up to 30 PoNS systems was also received.
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Helius Medical Technologies has announced the publication of a white paper demonstrating that rehabilitative treatment with the Portable Neuromodulation Stimulator (PoNS) can significantly improve return-to-work outcomes for patients suffering from traumatic brain injury (TBI). The study, co-sponsored by Pacific Blue Cross and HealthTech Connex, showed that 56% of participants who were previously unable to work due to TBI returned to their prior occupations after 14 weeks of PoNS Therapy.
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Helius Medical Technologies, Inc. expects to report Q3 revenues between $140,000 and $150,000 due to the conclusion of the Patient Therapy Access Program. They also anticipate having approximately $7.0 million in cash and extending their cash runway into Q2 2024. The company will release its Q3 2023 financial results on November 9, 2023, and will host a conference call to discuss the results and provide an update on their progress and plans for the U.S. commercialization of PoNS®.
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Helius Medical Technologies receives letter of intent from Québec Ministry of Health and Social Services for purchase of 30 PoNS devices
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Helius Medical Technologies CFO to participate in upcoming conferences
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Helius Medical Technologies has announced that its PoNS system and mouthpiece have been assigned UPC numbers by Wolters Kluwer Health, allowing the company to pursue reimbursement through both pharmacy and DME/HCPCS pathways. The PoNS system has a direct price of $25,700 and the mouthpiece has a direct price of $7,900. This development is seen as a gamechanger for Helius, potentially expediting negotiations with third-party payers and providing dual paths for potential reimbursement.
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FAQ

What is the current stock price of Helius Med Technologies (HSDT)?

The current stock price of Helius Med Technologies (HSDT) is $0.439 as of April 1, 2025.

What is the market cap of Helius Med Technologies (HSDT)?

The market cap of Helius Med Technologies (HSDT) is approximately 2.4M.

What is the core focus of Helius Medical Technologies Inc?

Helius Medical Technologies Inc specializes in developing, licensing, and acquiring non-invasive neuromodulation technologies to treat neurological deficits and improve patient mobility.

What conditions does the PoNS device target?

The PoNS device primarily targets gait and balance deficits associated with conditions such as multiple sclerosis, traumatic brain injury, and stroke, by promoting neuroplasticity.

How does the PoNS device work?

The PoNS device is an orally applied therapeutic tool that uses mild electrical impulses through a tongue-mounted mouthpiece to stimulate cranial nerves and activate neural pathways.

What is the significance of neuroplasticity in Helius' treatment approach?

Neuroplasticity refers to the brain's ability to adapt and rewire itself. Helius leverages this concept through neuromodulation to help improve motor functions and mitigate neurological deficits.

How does Helius generate revenue?

The company generates revenue primarily through the commercialization of its PoNS device, supported by strategic partnerships, licensing agreements, and integration with healthcare systems, including federal agencies.

What makes Helius competitive in the neurotechnology space?

Helius differentiates itself through a proven therapeutic approach, rigorous clinical validation, proactive regulatory engagement, and partnerships that enable market access and reimbursement.

What role do research and clinical trials play for the company?

Research and clinical trials are fundamental to Helius' strategy, helping to establish efficacy, drive regulatory approval, and refine treatment protocols to better serve patients with neurological conditions.

How is Helius engaging with regulatory bodies?

Helius actively collaborates with regulatory agencies to secure device approvals and reimbursement codes, ensuring that its innovative neuromodulation therapy meets the standards required for widespread clinical use.
Helius Med Technologies Inc

Nasdaq:HSDT

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2.40M
6.11M
0.53%
6.63%
0.34%
Medical Devices
Electromedical & Electrotherapeutic Apparatus
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United States
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