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

Clinical data overview

• 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 94.0%.

• The average number of applications per patient was 12.8, with a left atrial dwell time of 21.0 minutes.

• The procedure demonstrated efficiency, safety, and durable clinical outcomes.

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.

Study design and workflow

• The trial was prospective, non-randomized, open-label, and single-arm, conducted at three centers with nine operators.

• The workflow involved two applications per pulmonary vein, with single ostial and antral applications depending on anatomy.

• The system features 12 sensing electrodes and a graphical user interface for procedure management.