PULSE BIOSCIENCES, INC. 8-K

What Happened

• Pulse Biosciences (PLSE) announced on February 5, 2026 (press release filed via 8-K) 6- and 12-month data from its first-in-human feasibility study of the nPulse™ Cardiac Catheter System for treating atrial fibrillation. Data were presented by Dr. Vivek Reddy at the 31st Annual AF Symposium 2026 in Boston. The endocardial catheter uses proprietary nanosecond pulsed-field ablation (PFA) energy to deliver a circumferential ablation in a single treatment cycle.

Key Details

• Study scope: 165 patients treated to date by nine investigators in Europe; initial cohort of 150 patients evaluated for follow-up remapping (~3 months) and rhythm control at 6 and 12 months.
• Effectiveness: procedural success in evaluable patients was 100% at 6 months (75/75) and 96% at 12 months (45/47).
• Procedure metrics: average applications 16.1 ± 5.2 per procedure; total procedure time 65 ± 28 minutes; fluoroscopy time 9.8 ± 5.8 minutes; left atrial dwell time 21.0 ± 13.3 minutes.
• Safety: 1.3% of subjects (2/150) experienced a serious adverse event (SAE) related to the study’s primary safety endpoint.

Why It Matters

• These are early human data showing high procedural success and a low SAE rate in the evaluated cohort, which are key signals for an early-stage cardiac device program. For investors, the results may indicate technical feasibility and initial safety of the nPulse system, important milestones in clinical development.
• Caveats important to note: this is a first-in-human feasibility study with limited follow-up numbers (evaluable counts drop at later time points), and the filing does not announce regulatory filings or commercialization steps. Continued larger or longer-term studies will be needed to confirm durability and broad safety before potential regulatory or commercial milestones.