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  • Pre-Market Momentum Builds For Helius Medical (HSDT) Stock

    Pre-Market Momentum Builds For Helius Medical (HSDT) Stock

    Shares of Helius Medical Technologies, Inc. (NASDAQ: HSDT) jumped 90.22% to $16.93 in pre-market trading following the company’s announcement of very positive Stroke Registrational Program (SRP) findings.

    Breakthrough Clinical Results from PoNS Therapy

    Helius Medical, operating under the FDA’s Breakthrough Device Designation, announced positive results from its Portable Neuromodulation Stimulator (PoNS) Stroke Registrational Program.

    In stroke patients receiving active PoNS therapy, the program’s main double-blind randomized controlled study demonstrated a statistically significant improvement in gait and balance, meeting its primary aim. Even after integrating data from an open-label research using statistical techniques to balance baseline characteristics, these benefits persisted.

    Furthermore, the studies showed acceptable patient acceptability and reported few side effects, supporting the PoNS device’s safety profile.

    A Step Forward in Post-Stroke Care

    The SRP’s positive outcomes represent a significant advancement for Helius Medical in improving chronic stroke patients’ recovery. According to the business, the results might open up a new treatment option for the more than 7 million Americans who suffer from the long-term consequences of stroke, 80% of whom have severe impairments in their gait and balance.

    Later this quarter, Helius plans to submit these data to the FDA for consideration as part of an application for an indication in stroke rehabilitation

    Coordinated Multi-Trial Effort Supports FDA Submission

    The SRP was launched in March 2024 and consists of two sponsor-initiated pivotal trials: a single-arm study that began in April 2024 and a double-blind, randomized controlled trial. The findings are further supported by another investigator-led research that was started in late 2023 by Drs. Steve Kautz (MUSC) and Mark Bowden (Brooks Rehabilitation).

    All three trials were structured with consistent study designs and endpoints to measure improvements in gait and balance after 12 weeks of PoNS therapy.

    Path Ahead for Regulatory Review

    Under the existing Breakthrough Device Designation, Helius Medical intends to submit to the FDA in Q3 2025. The business is hopeful that these strong clinical findings will speed up regulatory approval and eventually offer significant comfort for stroke survivors, even if the PoNS device is not currently licensed in the United States for stroke-related rehabilitation.

  • Helius Medical (HSDT) Rockets Spontaneously in Premarket Trading

    Helius Medical Technologies, Inc. (NASDAQ: HSDT) underwent a tumultuous ride on Thursday, experiencing a staggering 27% plunge. However, investors were in for a surprise during the early premarket hours on Friday as the stock made a remarkable turnaround, erasing the previous day’s losses and surging by over 35%.

    Broader Uncertainty

    The premarket trading frenzy saw an unprecedented volume, with nearly 7 million shares changing hands, a stark contrast to the average figure of less than half a million shares.

    Despite the lack of immediate news catalysts, speculations abound regarding a potential royalty deal, characterized by non-dilution and no additional shares. This uncertainty has left many investors wary, fearing a potential profit-taking dip in the coming days.

    Adding to the intrigue, Helius Medical Technologies is gearing up to announce its earnings in just nine days. The significant premarket surge raises questions about the company’s performance expectations. Some investors speculate that the substantial movement suggests positive earnings, anticipating a potential “rip” after the recent “dip.”

    Safety Profile

    In light of recent developments, investors are closely monitoring Helius Medical Technologies’ safety and tolerability profile of its PoNS Therapy. The therapy boasts an impressive safety record, with reported adverse events typically mild and unrelated to PoNS treatment itself. Clinical studies conducted by Dr. Galea and others have demonstrated promising results, with no serious device-related adverse events reported.

    Furthermore, regulatory approvals have significantly expanded Helius Medical Technologies’ market reach. With marketing authorizations from Health Canada for the treatment of balance deficit due to mmTBI, gait deficit in MS patients, and stroke gait deficit symptoms, the company has unlocked new avenues for growth and market penetration.

    Conclusion

    As the market eagerly awaits Helius Medical Technologies’ earnings announcement, investors remain cautiously optimistic about the company’s future prospects. The volatile premarket trading activity underscores the market’s sensitivity to any news or developments surrounding the company, highlighting the importance of diligence and strategic decision-making in navigating the dynamic landscape of healthcare investments.

  • Notable Partnership Boosts Helius Medical (HSDT) Stock

    Notable Partnership Boosts Helius Medical (HSDT) Stock

    Helius Medical Technologies, Inc. (NASDAQ: HSDT) is witnessing a notable surge of 22.83% during the pre-market trading session, currently valued at $6.95 per share. This positive momentum in HSDT shares can be directly attributed to the recent announcement of a strategic partnership.

    Today, Helius Medical (HSDT) and Lovell Government Services announced their partnership. Through this partnership, HSDT will be able to provide government healthcare systems with access to its Portable Neuromodulation Stimulator (“PoNS”). PoNS can be used to treat gait impairments in people with mild to moderate symptoms of multiple sclerosis (MS) in conjunction with physical therapy.

    Helius Medical and Lovell’s partnership will make the revolutionary point-of-care technology (PONS) more widely available. Through its Multiple Sclerosis Centers of Excellence, the Department of Veterans Affairs (VA) is dedicated for enhancing the quality of life for veterans who suffer from multiple sclerosis.

    After receiving PoNS Therapy for 14 weeks, 100% of MS patients had clinically significant improvements in their gait, according to a real-world efficacy study. PoNS has the potential to completely transform the way that veterans and their families are treated, as the VA receives reports on over 28,000 MS cases each year.

    The VA, with the most integrated healthcare system in the country, is committed to provide lifelong comprehensive treatment to veterans with multiple sclerosis. Veterans should have access to the most cutting-edge and effective resources available since they have made important contributions to their nation.

    Recently, Helius Medical spotlighted the personal narrative of Kevin Byrne, a retired U.S. veteran grappling with MS since 1999. Gait impairments had robbed him of cherished experiences with his 13-year-old daughter, yet PoNS Therapy aided in enhancing his walking abilities, including speed, endurance, and distance.

    Following treatment with PoNS, he was able to accompany his daughter to New York City, where they relished strolling the streets and attending Broadway shows—experiences he believed were forever out of reach. While clinical data underscores the effectiveness of PoNS Therapy, firsthand testimonials such as Captain Byrne’s serve as the most rewarding validation of its impact.