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.
Helius Medical Technologies (NASDAQ:HSDT) has announced the establishment of Revelation Neuro, a wholly-owned private subsidiary focused on developing non-implantable AI-powered Brain Computer Interface (BCI) technology. The subsidiary will leverage Helius' existing IP portfolio and extensive data warehouse for AI algorithm development.
The new venture aims to create a personalized neurorehabilitation solution using translingual stimulation without implantation. Revelation Neuro will utilize Helius' dataset of over 5 years of movement dysfunction clinical evidence from 400+ subjects as the foundation for AI algorithm development. The technology focuses initially on motor function rehabilitation, with potential future applications in cognitive deficit, mood, and behavior disorders.
While Helius will assign its newly developed IP and license existing IP to Revelation Neuro, the company does not plan to invest significant additional capital. Instead, the subsidiary is expected to be financed through third-party outside sources, building upon the $70 million already invested in neuromodulation technology development.
Helius Medical Technologies (HSDT) has achieved a significant milestone with its first reimbursement from a major healthcare provider for its Portable Neuromodulation Stimulator (PoNS®) Device. Anthem Blue Cross Blue Shield approved the claim at an out-of-network adjusted list price.
The reimbursement payment, including patient co-payment, amounted to $15,420 for the PoNS controller and mouthpiece. This out-of-network total lump sum payment, typically 30-40% below in-network contracted rates, establishes a important benchmark for future negotiations with major commercial insurance carriers.
The company views this development as validation of PoNS's therapeutic benefit and economic value for payers, particularly significant as Helius appeals current CMS payment rates.
Helius Medical Technologies (NASDAQ:HSDT) has announced positive results from their PoNS Therapeutic Experience Program (PoNSTEP) study for multiple sclerosis (MS) patients. The study demonstrated significant long-term benefits of PoNS Therapy on gait deficit improvement.
The study involved 43 MS patients who underwent 14 weeks of physical rehabilitation with PoNS Therapy, including 2 weeks in clinic (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month observation period (Phase 3). Of 41 patients who started, 38 completed the study.
Key findings include a statistically significant total mean improvement of 5.00 points in Dynamic Gait Index (DGI) at week 14. Phase 2 showed 71% therapy adherence with a linear association between adherence and improvement. Notably, participants with ≥85% adherence improved by mean 3.7 points compared to 2.0 points for those with lower adherence. At 6-months post-treatment, only 1 of 28 reassessed participants showed ≥30% decline in DGI.
Helius Medical Technologies (NASDAQ:HSDT) has announced agreements with existing warrant holders to exercise warrants for 4,971,110 shares at a reduced price of $0.751 per share, expecting to generate approximately $3.7 million in gross proceeds. In exchange, the company will issue new warrants in a private placement.
The new warrants will be exercisable for up to 6,213,888 shares at $0.751 per share, subject to stockholder approval. Of these, 3,728,333 warrants will be exercisable for five years and 2,485,555 for two years after stockholder approval. Roth Capital Partners is acting as financial advisor for this transaction.
The company plans to file a resale registration statement with the SEC to register the shares underlying the new warrants. The existing warrant shares are already registered under Form S-1.
Helius Medical Technologies (NASDAQ:HSDT) has exceeded its initial enrollment target for its stroke registrational program, reaching 128 participants by December 31, 2024, surpassing the original goal of 90 participants. The company expects to reach maximum enrollment of 150 participants by January 2025.
The program aims to demonstrate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors. The FDA granted Breakthrough Designation for PoNS in stroke in 2021, and Helius remains on track for FDA submission in Q2 2025.
The registrational program consists of three studies: a randomized placebo-controlled trial at MUSC, a company-sponsored open-label study across five U.S. Centers of Excellence, and another randomized placebo-controlled trial across sites in Canada and the U.S. The studies focus on gait and balance improvement, reduced risk of falling, and maintenance of effect at 12 weeks post-treatment.
Helius Medical Technologies (NASDAQ:HSDT) announced its first PoNS System sale to the VA Healthcare System through distributor Lovell Government Services. The sale, priced at $23,844 ($16,499 for Controller, $7,345 for Mouthpiece), marks the operational implementation through VA Federal Supply Schedule Contract.
The PoNS System, indicated for treating gait deficit in adults with mild-to-moderate MS symptoms when used with physical therapy, targets a potential market of 55,000 to 70,000 veterans living with MS in the U.S. The company has sales professionals covering VA locations along the east coast and southeast, with plans to expand coverage to all VA MS Centers of Excellence network facilities.
Helius Medical Technologies (NASDAQ:HSDT) provided updates on reimbursement challenges for its Portable Neuromodulation Stimulator (PoNS) device. The company disagrees with CMS's proposed pricing for both the PoNS Mouthpiece and Controller, stating it reflects incomplete information and incorrect technology assessment. The pricing decisions have delayed access to PoNS Therapy for Multiple Sclerosis patients with balance and gait deficits. The company has requested a meeting with CMS before the January 1, 2025 Mouthpiece pricing implementation and is seeking to align Controller pricing implementation with the same date instead of April 1st.
Helius Medical Technologies (Nasdaq:HSDT) has initiated a strategic alternatives review process to maximize stockholder value. The company's decision follows challenges stemming from CMS's deferral of reimbursement payment determination for the PoNS Controller and inadequate PoNS Mouthpiece pricing in October, which has restricted operational advancement and traditional financing access. B. Riley Securities has been engaged as financial advisor to explore options including acquisition, merger, reverse merger, business combination, asset sale, and licensing opportunities.
Helius Medical Technologies, a neurotech company focused on innovative treatments for balance and gait deficits, has announced its participation in the 2024 ThinkEquity Conference. The event, scheduled for October 30, 2024, will take place at the Mandarin Oriental Hotel in New York.
Helius management will be presenting at 4:30pm ET and conducting one-on-one investor meetings throughout the day. The ThinkEquity Conference is a platform that brings together institutional investors, corporate clients, and industry professionals to showcase groundbreaking innovations and financial strategies.
Interested investors can register to attend the conference and schedule meetings with Helius representatives. This event provides an opportunity for Helius to highlight its novel therapeutic neuromodulation approach and engage with potential investors.
Helius Medical Technologies (Nasdaq:HSDT) announced updates on CMS reimbursement determinations for its Portable Neuromodulation Stimulator (PoNS®) device. The PoNS Mouthpiece (HCPCS code A4594) reimbursement was set at $2,963.30 as a lump sum payment, effective January 1, 2025. Helius plans to challenge this determination, arguing it's based on discontinued temporary pricing and doesn't reflect current market rates.
CMS deferred the national reimbursement payment determination for the PoNS Controller (HCPCS Code A4593) to the next cycle. A preliminary rate of $519.80 was published, comparing it to TENS devices. Helius disagrees with this comparison and will present its case at the November 8, 2024 HCPCS public meeting.
CEO Dane Andreeff expressed strong disagreement with CMS' methods and pricing, emphasizing the company's significant R&D investment and the FDA's Breakthrough Device designation for PoNS. Helius aims to establish fair reimbursement to improve access for MS patients with gait deficits.
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