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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.

Rhea-AI Summary

Helius Medical Technologies, Inc. will release its first quarter 2024 financial results on May 13, 2024. The company, focused on innovative neuromodulation therapies, will discuss progress and plans for U.S. commercialization of PoNS® during a conference call hosted by its executives.

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Helius Medical Technologies, Inc. announced the pricing of a $6.4 million public offering involving shares of Common Stock and Pre-Funded Warrants. The offering is expected to close on May 9, 2024, with net proceeds going towards operations and general corporate purposes.

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Helius Medical Technologies, Inc., a neurotech company, announced the Centers for Medicare & Medicaid Services preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece, with a public meeting scheduled for May 29, 2024. CMS proposed pricing based on cash pay rates, with the PoNS Mouthpiece capped at $3,075.53 and the PoNS Controller at $1,206.53. Helius plans to present at the meeting to advocate for higher reimbursement rates, intending to expand reimbursement and achieve positive cash flow.

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Helius Medical Technologies, Inc. partners with Shepherd Center to expand stroke clinical program for PoNS device, aiming to rehabilitate walking mobility in chronic stroke survivors. The study will evaluate PoNS therapy in treating gait and balance deficits, with regulatory submission for stroke expected in 2025.
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Helius Medical Technologies partners with Lovell Government Services to make PoNS device available to federal healthcare systems for MS patients, showing promising real-world results.
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Helius Medical Technologies, Inc. (HSDT) announces Q4 and full year 2023 results, including revenue decline, operational updates, and financial data. The company secured HCPCS codes for PoNS Therapy, expanded stroke program, signed LOI with MSSS, and released study results. Despite revenue decline, operating expenses decreased, and $1.3 million was raised in Q1 2024 under the ATM program. The PR highlights progress towards Medicare reimbursement, stroke patient treatment, and financial stability.
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Helius Medical Technologies, Inc. (NASDAQ: HSDT) announced the release of its fourth quarter and full year 2023 financial results on March 28, 2024. The Company will discuss its progress and plans for the U.S. commercialization of PoNS® during a conference call hosted by its President and CEO, Dane C. Andreeff, and CFO, Jeffrey S. Mathiesen.
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Helius Medical Technologies, Inc. initiates an open-label study for its registrational program in stroke, focusing on the use of Portable Neuromodulation Stimulator (PoNS®) for gait and balance deficits in chronic stroke survivors. Enrollment of ten patients at Brooks Rehabilitation marks the beginning of the study, aiming to support U.S. authorization under PoNS's breakthrough designation for stroke.
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Helius Medical Technologies, Inc. to present at the 36th Annual ROTH Conference, showcasing their innovative neuromodulation approach for balance and gait deficits.
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Helius Medical Technologies, Inc. (HSDT) achieves a significant milestone with CMS assigning HCPCS Level II codes for PoNS Therapy for MS patients, extending cash runway with recent stock issuances. The company anticipates reimbursement negotiations with third-party payers and potential positive cash flow post-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 $0.39 as of April 4, 2025.

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

The market cap of Helius Med Technologies (HSDT) is approximately 2.3M.

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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2.27M
6.11M
0.53%
6.63%
0.34%
Medical Devices
Electromedical & Electrotherapeutic Apparatus
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United States
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