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Pulse Biosciences (PLSE) guidance and outlook

Pulse Biosciences' 10-Q filed Nov 5, 2026 makes 27 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 5, 2026

• We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells.
• While these devices serve different physicians, the application of nsPFA energy to safely and effectively ablate cardiac tissue to treat AF are the same, and we believe there will be important synergies realized through their contemporaneous development.
• We believe this will enable faster treatment times compared to what is currently performed with thermal modalities, especially when ablating around the pulmonary veins, a common treatment approach for AF.
• We believe these advantages will be important to electrophysiologists, so we are working with leaders in the field to develop this technology quickly.
• In October 2026, we announced achievement of our enrollment target of 164 evaluable patients across 15 clinical sites and 36 operators.
• We continue to believe we will need PMA approval from the FDA to market and sell our catheter with a paroxysmal and persistent AF indications in the United States.
• Upon PMA approval, we would expect to commercialize the nPulse Cardiac Catheter System in the United States, specifically as a treatment for AF, potentially through one or more strategic partnerships with electrophysiology market leaders.
• We believe these advantages will be important to cardiac surgeons, so we are working with leaders in the field to develop this technology quickly.
• Over the last several years, we have been developing the cardiac ablation clamp from proof-of-concept to prototype, and we now have what we believe will be our initial commercial design.
• The device was designed with the input of key physicians in cardiac surgery, and we believe it will offer a highly differentiated option relative to the standard of care thermal modalities.
• Today, we plan to pursue a PMA application for FDA approval to market the cardiac clamp specifically as a surgical way to treat both paroxysmal and persistent AF.
• Upon PMA approval, we would expect to commercialize the nPulse Cardiac Surgical System in the United States specifically as a treatment for AF.

Pulse Biosciences' latest quarter

Questions

What does Pulse Biosciences expect?

We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells. While these devices serve different physicians, the application of nsPFA energy to safely and effectively ablate cardiac tissue to treat AF are the same, and we believe there will be important synergies realized through their contemporaneous development. We believe this will enable faster

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.