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) reported Q4 and full-year 2020 financial results, showing revenue of $191,000 for Q4, up from $152,000 in Q4 2019, but down to $0.7 million for the full year from $1.5 million in 2019. Operating losses improved to $3 million in Q4 from $5.6 million a year prior, while net losses narrowed to $2.5 million. The company closed private placements totaling $12.8 million, expected to fund operations into Q1 2022. Helius aims for FDA clearance of its PoNS device and increased its Canadian clinic network to 31.
Helius Medical Technologies (HSDT) has closed an underwritten public offering, raising approximately $11.0 million. This includes the exercise of the underwriter’s over-allotment option, with units priced at $14.82 each. Each unit comprises one share of common stock and a warrant for an additional 0.5 shares at an exercise price of $16.302, expiring five years after issuance. A total of 744,936 shares and 372,468 warrants were issued. The offering was conducted under registration statements effective as of January 27, 2021.
Helius Medical Technologies (Nasdaq:HSDT) announced the pricing of an underwritten public offering, raising approximately $9.6 million before expenses. The offering consists of 647,772 units, each priced at $14.82, and includes one share of common stock along with a warrant for 0.5 shares at an exercise price of $16.302. The closing is expected around February 1, 2021. Ladenburg Thalmann & Co. Inc. is the sole bookrunning manager. The company has also granted underwriters a 45-day option for over-allotments.
Helius Medical Technologies (Nasdaq:HSDT) responded positively to the Centers for Medicare & Medicaid Services' (CMS) new Medicare Coverage of Innovative Technology (MCIT) pathway established on January 12, 2021. This initiative enables national Medicare coverage for FDA-designated breakthrough devices from the date of market authorization for up to four years. Should Helius secure FDA clearance for its Portable Neuromodulation Stimulator (PoNS), immediate coverage for beneficiaries could enhance access for approximately 60 million Medicare enrollees.
Helius Medical Technologies (Nasdaq:HSDT) has announced that it has cured its minimum bid price deficiency, allowing its stock to remain listed on The Nasdaq Capital Market. The scheduled hearing for a non-compliance appeal has been canceled following this compliance confirmation from Nasdaq. Helius focuses on developing non-invasive technologies aimed at neurological wellness, with its first product being the Portable Neuromodulation Stimulator (PoNS™), currently under review by the FDA in the U.S. and the Australian Therapeutic Goods Administration.
Helius Medical Technologies, a neurotech company, will participate in the Noble Capital Markets 17th Annual Small & Microcap Investor Conference on January 19-20, 2021. Management's presentation is scheduled for January 19 at 11:15 a.m. ET. A live audio webcast will be accessible following free registration on the Noble conference website. Helius focuses on developing non-invasive technologies for neurological wellness, including the Portable Neuromodulation Stimulator (PoNS™), currently under FDA review.
Helius Medical Technologies has formally responded to the FDA's request for additional information regarding the de novo classification of its Portable Neuromodulation Stimulator (PoNS™) for treating gait deficits due to Multiple Sclerosis (MS). This response aims to resume the FDA's review process, which was on hold following a previous request from the agency. The company anticipates a decision from the FDA in the first half of the year. Helius previously obtained Breakthrough Designation for PoNS™ in May 2020.
Helius Medical Technologies, Inc. (Nasdaq:HSDT) reported unusual trading activity for its Class A Common Stock on the Toronto Stock Exchange and The Nasdaq Capital Market. The company confirmed it is unaware of any undisclosed material changes impacting its business that could explain the recent trading price increase. In conjunction, Helius has made available an investor presentation in anticipation of its participation in upcoming investor conferences this January, previously announced on January 4, 2021.
Helius Medical Technologies (Nasdaq:HSDT) has announced participation in several virtual investor conferences during January 2021. Key events include:
- The Demy-Colton Digital Medicine and Medtech Showcase from January 11-15, with on-demand access starting January 6th.
- The H.C. Wainwright BioConnect Conference from January 11-14, with presentations available on January 11th.
- The Sidoti Winter 2021 Conference on January 13-14, where management will present on January 13th.
- The ICR Conference from January 11-14, with management presenting on January 14th.
Helius Medical Technologies (HSDT) announced a 1-for-35 reverse stock split effective December 31, 2020, aimed at complying with Nasdaq listing requirements. Consequently, the outstanding shares will decrease from approximately 51.9 million to 1.5 million, while the number of authorized shares remains at 150 million. The common stock will trade on a split-adjusted basis starting January 4, 2021. Shareholders will receive cash for any fractional shares. More details can be found in the definitive proxy statement filed with the SEC.
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