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) will release its Q2 2022 financial results on August 15, 2022, after market close. CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen will host a conference call at 4:30 p.m. ET to discuss results and provide updates on the U.S. commercialization of its product, the Portable Neuromodulation Stimulator (PoNS). This innovative device aims to assist individuals with gait deficits due to multiple sclerosis. The conference call requires prior registration for dial-in details.
Helius Medical Technologies (Nasdaq: HSDT) announced a public offering of 24 million shares of Class A common stock and warrants for 36 million shares, priced at $0.75 each. The offering is expected to close around August 9, 2022, aiming to raise approximately $18 million in gross proceeds, intended for funding operations and working capital. Roth Capital Partners and Maxim Group are the lead and co-placement agents, respectively. The offering is registered under effective SEC statements, ensuring compliance with securities laws.
Helius Medical Technologies (Nasdaq:HSDT) has launched a new online training module for physical therapists aimed at treating gait deficits in multiple sclerosis (MS) patients. This shift from in-person training to an online format allows therapists to complete the training in under three hours, significantly increasing accessibility. Currently, 55 therapists in the U.S. and 20 in Canada are queued for training. Helius aims to standardize training and enhance the delivery of PoNS Therapy, intended for individuals with mild to moderate MS symptoms.
Helius Medical Technologies (Nasdaq: HSDT) presented a poster on the effectiveness of its Portable Neuromodulation Stimulator (PoNS) Therapy at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting. The study demonstrated significant gait improvement in patients with multiple sclerosis (MS) after two weeks of therapy. The poster was nominated for the prestigious Labe C. Scheinberg Award, highlighting its impact in advancing MS care. Helius plans to gather further evidence through its Therapeutic Experience Program, reinforcing its commitment to improving neurological wellness.
Helius Medical Technologies (Nasdaq:HSDT) launched a Patient Therapy Access Program (PTAP) to improve access to its Portable Neuromodulation Stimulator (PoNS) Therapy for patients with multiple sclerosis (MS). This initiative offers eligible patients reduced pricing for PoNS, which is prescribed for gait deficits due to mild-to-moderate MS symptoms. The program aims to drive adoption of PoNS Therapy and supports data collection for future clinical evidence. PTAP will run until December 31, 2022, enhancing access for first-time users of the therapy.
Helius Medical Technologies (Nasdaq: HSDT) announced a poster presentation at the Consortium for Multiple Sclerosis Centers (CMSC) Annual Meeting from June 1-4, 2022. The highlighted abstract showcases real-world data indicating that translingual neurostimulation can effectively improve gait in multiple sclerosis patients. Chief Medical Officer Antonella Favit-Van Pelt emphasized the benefits of neuromodulation in enhancing walking stability and promoting neuroplasticity. The presentation is scheduled for June 2 at 5:00 p.m. ET, with Helius representatives available to discuss the Portable Neuromodulation Stimulator (PoNS) device at Booth #804.
Helius Medical Technologies (HSDT) announced that its independent directors have approved the issuance of equity awards as part of its 2021 Inducement Plan, effective May 23, 2022. Four new employees, not previously associated with Helius, received options to purchase a total of 21,000 shares at an exercise price of $1.40 each, which reflects the closing stock price on the date of the grant. These options will vest over four years, providing Helius with a strategic advantage in attracting talent while adhering to Nasdaq regulations.
Helius Medical Technologies has expanded its Therapeutic Experience Program (TEP) by adding Shepherd Center in Atlanta as a second Center of Excellence. This multi-center observational trial aims to assess the effectiveness of Portable Neuromodulation Stimulator (PoNS) therapy for gait improvement in patients with multiple sclerosis (MS). Led by Dr. Deborah Backus, the program will provide valuable data on treatment adherence and outcomes, with enrollment expected to begin in Q2 2022.
Helius Medical Technologies (HSDT) reported a 126% increase in Q1 2022 revenue to $190,000, up from $84,000 in Q1 2021. The U.S. commercial launch of PoNS for multiple sclerosis began, with 23 prescriptions written. Operating loss widened to $4.6 million compared to $3.5 million in Q1 2021. Cash used in operations rose to $4.7 million from $2.9 million. The company anticipates being cash flow positive by Q4 2023, projecting sequential revenue growth beyond the first quarter.
Helius Medical Technologies (NASDAQ: HSDT) will release its Q1 2022 financial results on May 12, 2022, before market opening. CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen will lead a conference call to discuss the results and provide insights into Helius' plans for the U.S. commercialization of PoNS®, its first medical device aimed at improving neurological wellness. The call is scheduled for 9:00 a.m. ET, with details available via the webcast.