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) announced the publication of a peer-reviewed study demonstrating that translingual neural stimulation (TLNS) with the PoNS device may facilitate structural brain changes leading to functional recovery in patients with mild-to-moderate traumatic brain injury (TBI). The study showed significant increases in grey matter volume in brain regions associated with balance and movement after treatment. This suggests TLNS combined with physical therapy may enhance recovery. The findings contribute to the growing body of evidence supporting the therapeutic potential of PoNS technology.
Helius Medical Technologies (HSDT) announced a peer-reviewed study published in EMJ Radiology highlighting the effectiveness of its Portable Neuromodulation Stimulator (PoNS) in treating balance issues after mild-to-moderate traumatic brain injury (TBI). The study evaluated 9 patients and demonstrated significant increases in grey matter volume within the cerebellum and temporal regions, correlating with improved functional assessments. The research indicates that TLNS combined with physical therapy may effectively address balance disorders.
Helius Medical Technologies (Nasdaq: HSDT) has announced its participation in upcoming investor conferences in September. Key presentations include the LD 500 Virtual Investor Conference on September 1 at 1:20 p.m. ET, the Wall Street Investor Forum Virtual Conference on September 10 at 9:20 a.m. ET, and the H.C. Wainwright 22nd Annual Global Investment Conference from September 14-16, with its presentation on September 16 at 12:00 p.m. ET. Webcasts will be available on their investor relations website.
Helius Medical Technologies (NASDAQ:HSDT) announced that Philippe Deschamps has resigned as President and CEO, effective August 23, 2020. Dane C. Andreeff and Blane Walter have been appointed as Interim President and CEO, and Chairman, respectively. The Board expressed gratitude for Deschamps' leadership during his seven-year tenure, highlighting the company's transition to a public entity. Andreeff, a board member since 2017, is recognized for his extensive experience in healthcare and is expected to drive Helius' regulatory and operational progress. The PoNS device is currently awaiting FDA clearance.
Helius Medical Technologies (HSDT) reported Q2 2020 financial results, with revenue of $0.1 million, down from $0.5 million in Q2 2019. The operating loss narrowed to $3.7 million from $5.8 million. Net loss was $3.4 million, compared to a $0.2 million loss a year prior. Cash on hand was $5.3 million as of June 30, 2020. Recent developments include receiving Breakthrough Designation for the PoNS™ device and the submission for FDA review. The company anticipates ongoing challenges due to COVID-19 affecting clinic operations in Canada.
Helius Medical Technologies (NASDAQ: HSDT) will announce its second quarter fiscal year 2020 financial results on August 12th, after market close. A conference call, scheduled for the same day at 5:00 p.m. ET, will provide insights into the quarterly performance. Participants can join via phone or through a live webcast available on the investor relations website. The company focuses on neurological wellness, with its first product, the Portable Neuromodulation Stimulator (PoNS), aimed at treating gait deficits from mild to moderate neurological conditions. PoNS is currently under FDA review.
Helius Medical Technologies (NASDAQ: HSDT) has submitted a request to the FDA for de novo classification and clearance of its Portable Neuromodulation Stimulator (PoNS) device, aimed at treating gait deficits in Multiple Sclerosis patients. The device was granted Breakthrough Designation on May 7, 2020. Preliminary Q2 2020 revenue is expected to be $0.1 million, down from $0.5 million in Q2 2019, while operating loss is projected at $3.7 million, an improvement from $5.8 million year-over-year. Cash reserves stand at $5.3 million as of June 30, 2020.
Helius Medical Technologies (Nasdaq: HSDT) announced its participation in the Virtual Summer Summit, scheduled from June 9th-12th, 2020. Management will present on June 9th at 4:30 p.m. ET. A live audio webcast will be available on the company's investor relations website, with an archived replay after the conference.
Helius focuses on neurological wellness, developing non-invasive technologies. Its first product, the Portable Neuromodulation Stimulator (PoNS™), targets gait deficits from neurological conditions.
Helius Medical Technologies (NASDAQ: HSDT) announced Breakthrough Designation for its PoNS™ device, aimed at treating gait deficits in Multiple Sclerosis patients. This designation allows expedited development and assessment by the FDA, with the goal of improving patient mobility through a non-drug treatment approach. The PoNS device is currently authorized in Canada and under investigation in the U.S. and other regions. The Breakthrough Devices Program facilitates timely access for critical medical devices while ensuring compliance with regulatory standards.
Helius Medical Technologies (HSDT) reported Q1 2020 financial results revealing a revenue decline to $0.2 million from $0.7 million in Q1 2019, driven primarily by decreased product sales of $191 thousand. The company experienced an operating loss of $4.0 million, a 41% improvement from the previous year. Net loss was $4.8 million, compared to a net income of $1.3 million in Q1 2019. Cash reserves decreased to $4.4 million as of March 31, 2020. Due to uncertainties from the COVID-19 pandemic, the full-year outlook has been withdrawn.
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