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, Inc. (Nasdaq: HSDT) closed its underwritten public offering of 1,385,031 shares of Class A common stock at $8.00 per share, generating approximately $11.1 million in gross proceeds. This includes the full exercise of the underwriter's over-allotment option. The company will utilize the net proceeds for funding operations, working capital, and other corporate purposes. The offering was conducted under a shelf registration statement declared effective by the SEC in 2020.
Helius Medical Technologies (Nasdaq:HSDT) reported its Q3 2021 financial results, with revenue of $109K, down from $131K in Q3 2020. Operating loss increased to $4.4M, compared to $3.7M in the prior year. The net loss was $4.7M, or $(2.01) per share. Helius received FDA Breakthrough Designation for its PoNS device for stroke-related gait deficits and launched a Therapeutic Experience Program with NYU. The company secured a $15 million equity line of credit and announced a $9.6 million public offering. Cash balance stood at $4.7 million as of Sept 30, 2021.
Helius Medical Technologies, Inc. (Nasdaq: HSDT) announced a public offering of 1,204,375 shares of common stock at $8.00 per share, aiming to raise approximately $9.6 million in gross proceeds. The offering will close around November 12, 2021, subject to customary conditions. The company plans to use the net proceeds for operations, working capital, and general corporate purposes. Ladenburg Thalmann & Co. Inc. serves as the sole book-running manager for the offering, which is conducted under an effective shelf registration statement.
Helius Medical Technologies (HSDT) announced a proposed underwritten public offering of its common stock. The company will sell all shares, with a potential additional 15% option for the underwriter. Proceeds from the offering will be directed towards funding operations, working capital, and general corporate purposes. This offering is contingent on market conditions and follows a shelf registration statement effective since February 6, 2020. Ladenburg Thalmann & Co. Inc. is the sole book-running manager for this offering.
Helius Medical Technologies (Nasdaq: HSDT) has launched its Therapeutic Experience Program (TEP) in partnership with NYU Langone Health to assess adherence to PoNS therapy in patients with multiple sclerosis (MS). The study aims to evaluate the effectiveness of the PoNS device in improving gait deficits, enrolling 50-60 patients across 10-12 Centers of Excellence in the U.S. Enrollment is expected to begin in Q4 2021 and continue through mid-2022. This program is pivotal for understanding the relationship between treatment adherence and therapeutic outcomes in a real-world setting.
Helius Medical Technologies (Nasdaq:HSDT) announced receiving market authorization from the Australian Therapeutic Goods Administration for its PoNS device as a Class IIa medical device. This authorization allows PoNS to be sold in Australia to aid patients in improving balance and gait when used alongside therapeutic exercises. The company is preparing for commercialization in Australia, marking the third country to authorize PoNS, following the U.S. and Canada. CEO Dane C. Andreeff expressed enthusiasm for this development.
Helius Medical Technologies (NASDAQ: HSDT) plans to release its third quarter 2021 financial results on November 10, 2021, after market close. CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen will host a conference call at 5:00 PM ET to discuss results and company updates. The Portable Neuromodulation Stimulator (PoNS®), Helius’s first commercial product, aims to assist patients with gait deficits from conditions like multiple sclerosis and traumatic brain injuries. PoNS® is currently authorized in the U.S. and Canada for specific medical uses.
Helius Medical Technologies (HSDT) announced that its compensation committee has approved equity awards for six new employees as part of its 2021 Inducement Plan. Effective October 28, 2021, these individuals will receive options to purchase a total of 22,000 shares of Class A common stock at an exercise price of $14.20 each. The options are set to vest over four years, contingent on the continuation of their employment. Helius focuses on neurotech solutions aimed at improving the lives of those affected by neurological diseases.
Helius Medical Technologies (Nasdaq: HSDT) announced that CEO Dane C. Andreeff will present at the Dawson James Small Cap Growth Conference on October 21, 2021, from 11:00-11:20 AM ET. Interested parties can access the live webcast via this link, which will also be available for 30 days post-event. Helius focuses on neurological wellness, developing the Portable Neuromodulation Stimulator (PoNS™), an FDA-authorized device for treating gait deficits related to multiple sclerosis and traumatic brain injury.
Helius Medical Technologies (HSDT) announced that CEO Dane C. Andreeff will present at the Benzinga Healthcare Small Cap Conference on September 29, 2021, at 1:35 PM ET. The event will be available via live webcast and archived on their website for 30 days. Helius focuses on neurological wellness and aims to develop non-invasive technologies, including its Portable Neuromodulation Stimulator (PoNS™), designed for treating gait deficits and balance issues associated with neurological conditions.
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