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    Why Pulse Biosciences (PLSE) Is Up 8.0% After FDA Clears Pivotal Atrial Fibrillation Trial

    Simply Wall St·12/22/2025 17:19:35
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    • Earlier this month, Pulse Biosciences received FDA Investigational Device Exemption approval to begin its NANOPULSE-AF clinical study of the nPulse Cardiac Catheter Ablation System in up to 145 patients with drug-resistant paroxysmal atrial fibrillation across as many as 30 global sites.
    • This milestone, supported by ongoing European feasibility experience with 150 patients, moves the company’s nsPFA cardiac platform into a pivotal phase of clinical validation with potential implications for future treatment practice.
    • Against this backdrop, we’ll explore how advancing the nPulse nsPFA cardiac catheter into a large FDA-approved trial shapes Pulse Biosciences’ investment narrative.

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    What Is Pulse Biosciences' Investment Narrative?

    To own Pulse Biosciences today, you really have to believe that its nsPFA platform can transition from promising feasibility data to regulatory approvals and, eventually, commercial use across both cardiac and oncology settings. The new IDE for the NANOPULSE-AF catheter trial is material here, because it upgrades the near term catalyst profile from small feasibility reads to a pivotal style safety and effectiveness study in up to 145 patients, on top of 150 European cases already treated. Alongside the MD Anderson thyroid cancer collaboration, the story is becoming more about a multi-indication bioelectric platform than a single-product bet. The flip side is that Pulse is still a pre-revenue, loss-making company with US$86,000 in sales, sizeable quarterly losses and no forecast path to profitability, so execution, timelines and funding remain front and center risks.

    However, there is a real funding and dilution question that investors should not ignore. Our comprehensive valuation report raises the possibility that Pulse Biosciences is priced higher than what may be justified by its financials.

    Exploring Other Perspectives

    PLSE 1-Year Stock Price Chart
    PLSE 1-Year Stock Price Chart
    Across three Simply Wall St Community fair value estimates, views span US$2.20 to US$22.00, underlining how differently people are sizing up Pulse’s pre-revenue risk, trial milestones and cash needs.

    Explore 3 other fair value estimates on Pulse Biosciences - why the stock might be worth less than half the current price!

    Build Your Own Pulse Biosciences Narrative

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.