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 (HSDT) reported its Q3 2020 financial results. Revenue was $131K, down from $150K in Q3 2019. Operating loss decreased to $3.7M from $5.7M year-over-year. The company closed a $3.4M private placement to support operations into Q1 2021. Following a leadership change, Helius continues to pursue FDA clearance for its Portable Neuromodulation Stimulator (PoNS) device to treat Multiple Sclerosis symptoms. Authorized clinics for PoNS treatment increased from 7 to 27 in Canada amid ongoing challenges from the COVID-19 pandemic.
Helius Medical Technologies (NASDAQ:HSDT) will present at the virtual Fall Investor Summit from November 16-18, 2020. This summit aims to connect smallcap and microcap companies with over 300 investors.
Helius focuses on developing non-invasive neurotech solutions, particularly the Portable Neuromodulation Stimulator (PoNS™). Currently authorized for sale in Canada, the PoNS™ is aimed at treating gait deficits associated with multiple sclerosis and mild traumatic brain injury. The device is under FDA review for potential use in the U.S.
Helius Medical Technologies (HSDT) announced its participation in several upcoming investor conferences. Management will present at the Investor Summit Group’s Virtual Fall Summit on November 17 at 1:00 p.m. ET. Additionally, they will engage in virtual 1x1 meetings at the Alliance Global Partners’ Virtual Healthcare Symposium on November 19, with no formal presentation. Furthermore, they will present at the Sidoti & Co. Virtual Fall Microcap Conference on the same day at 9:15 a.m. ET. Live webcasts will be available on Helius’s investor relations website.
Helius Medical Technologies has announced the expansion of its clinic network to 27 locations across Canada, enhancing access to PoNS Treatment for individuals with gait and balance deficits due to multiple sclerosis and traumatic brain injury. The initiative targets established neurorehabilitation providers in Ontario with existing referral networks. Helius aims for further clinic authorizations to support PoNS Treatment accessibility as it recovers from pandemic impacts. The PoNS device is currently under regulatory review in the U.S., EU, and Australia.
Helius Medical Technologies, Inc. (NASDAQ:HSDT) announced that it will release its third quarter fiscal year 2020 financial results on November 12, 2020, after market close. A conference call is scheduled for 5:45 p.m. ET the same day to discuss these results. Interested parties can join the call or access a live webcast via the company’s investor relations website. Helius focuses on developing non-invasive neurotechnology aimed at enhancing neurological wellness, with its leading product, the Portable Neuromodulation Stimulator (PoNS™), currently authorized for sale in Canada but still investigational in other markets.
Helius Medical Technologies (Nasdaq:HSDT) has successfully closed a private placement raising approximately $3.4 million through the sale of 6,567,868 Class A Common Stock shares and warrants. Each unit was sold at $0.52, with warrants exercisable at $0.452 per share for three years. Notably, affiliates of Helius' CEO and CFO participated under the same terms. The funds will support operations and general corporate purposes. These securities are subject to resale restrictions and the company will file a registration statement with the SEC for their resale.
Helius Medical Technologies (Nasdaq:HSDT) announced a private placement agreement to sell 6,664,022 shares of Class A Common Stock and warrants to purchase 3,332,013 shares at $0.52 per unit, totaling approximately $3.4 million. The closing is anticipated around October 23, 2020, pending customary conditions. Proceeds will fund operations and general corporate purposes. The placement includes related-party transactions but adheres to TSX exemptions, with the company intending to file a resale registration statement with the SEC. The PoNS™ device is under regulatory review in multiple regions.
Helius Medical Technologies (Nasdaq:HSDT) has received a request for additional information from the FDA regarding its Portable Neuromodulation Stimulator (PoNS™) device aimed at treating gait deficits in Multiple Sclerosis patients. The request, which occurred 75 days post submission, requires further clinical data analysis and labeling modifications. This follows the FDA granting Breakthrough Designation in May 2020, allowing for an expedited review process. Helius aims to respond promptly to ensure the continuation of FDA’s review process.
Helius Medical Technologies (NASDAQ: HSDT) announced a partnership with Berlin-based Breakthrough Health to conduct research on Multiple Sclerosis (MS) therapy options. The study will utilize Breakthrough's Emilyn application, engaging over 10,000 U.S. MS patients to gather anonymized data. This initiative aims to enhance the development of Helius's Portable Neuromodulation Stimulator (PoNS™) device, which aids in treating gait deficits in MS. Current PoNS™ status includes FDA review, with no commercial availability yet in the U.S. or other regions.
Helius Medical Technologies has formed a Multiple Sclerosis (MS) Scientific Advisory Board to enhance its U.S. launch strategy for its PoNS technology. The board, comprising nine leading MS experts, will advise on commercial, reimbursement, and market access strategies, focusing on the treatment of gait deficits due to MS. Their objectives include validating the positive effects of neuromodulation, guiding the launch strategy, and reviewing existing clinical data. The PoNS device is currently under FDA review and is not yet available in the U.S.
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