Pulse Biosciences (PLSE) Pulse Biosciences AF Symposium 2026 Analyst Event summary

Clinical data and study results

• The nsPFA FIH trial evaluated the Epicenter Catheter System in 150 adults with paroxysmal atrial fibrillation who failed or poorly tolerated at least one antiarrhythmic drug.

• Acute pulmonary vein isolation (PVI) success was 100%, with 3-month PVI success per vein at 89% and per patient at 80%.

• At 6 months, procedure success by Holter was 98.1%, and at 12 months, it was 96%.

• The average number of applications per patient was 16.1, with a left atrial dwell time of 21 minutes.

• Study included 165 patients treated by nine investigators across Europe.

Safety outcomes

• The primary safety endpoint showed a 1.3% rate of major adverse events in the total population.

• Specific complications included one case each of cardiac perforation/tamponade and stroke, both successfully managed.

• No deaths or esophageal injuries resulting in perforation were reported.

Technology and workflow

• nPulse Cardiac Catheter uses proprietary nanosecond Pulsed Field Ablation (nsPFA) energy for non-thermal ablation.

• The system features 12 sensing electrodes, a graphical user interface, and integrates with 3D mapping for precise ablation.

• Catheter design and zero rotation workflow contributed to efficient and effective pulmonary vein isolation.