Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of novel nPulse™ technology using proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced late-breaking positive clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at the Heart Rhythm 2026 meeting.

The late-breaking presentation included incremental participant follow up data. Building upon the previously reported data set presented at the AF Symposium meeting in February of 2026, the expanded 6-month follow-up participant cohort increased to 95 subjects from 75 and the expanded 12-month follow-up participant cohort increased to 53 subjects from 47.

Key study findings on the 5 second ablation cohort include:

Sustained 100% procedural success of evaluable patients by holter at 6 months (95/95)
Sustained 96% procedural success of evaluable patients by holter at one year (51/53)
Sustained 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year
Consistently efficient procedural performance, including:

Left atrial dwell time: 18.6 ± 13.0 minutes
Total procedure time: 60.2 ± 27.7 minutes
Fluoroscopy time: 9.4 ± 5.9 minutes
Average applications per-patient for PVI: 12.3 ± 2.6

Safety profile across total cohort: maintained low serious adverse event rate, with 1.7% (3/177) of subjects experiencing a SAE related to the primary safety endpoint

“These 12-month results are genuinely impressive,” said principal investigator Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY. “The durability of pulmonary vein isolation combined with the procedural efficiency we’re seeing is not something we typically expect together at this stage of development. The consistency across patients and sites is particularly striking.”

The results from the study demonstrate durable pulmonary vein isolation and consistent procedural performance using a non-thermal nsPFA energy approach across multiple investigator sites was sustained with increased subject follow up. The data was presented by Dr. Vivek Reddy during a late-breaking clinical session on April 25, and included incremental follow-up results from the first-in-human feasibility study in patients with atrial fibrillation.

“Our Cardiac Catheter continues to demonstrate durable pulmonary vein isolation with highly consistent long-term outcomes and an efficient procedural workflow,” said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. “The procedural efficiency we are seeing across 12 months of follow-up well exceeds my expectations, and reinforces the potential of nsPFA technology to meaningfully advance the field of atrial fibrillation ablation.”

The ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac Catheter System for the treatment of AF (NCT06696170). To date, a total of 177 patients have been treated by 7 investigators in Europe, including the Na Homolce Hospital in Prague led by Dr. Vivek Reddy and Prof. Petr Neuzil, Jessa Hospital in Hasselt led by Dr. Johan Vijgen, and Tor Vergata Hospital in Rome, led by Dr. Andrea Natale. The initial cohort of treated patients has been evaluated by remapping at ~3 months and for rhythm control completed at 6 and 12 months post ablation procedure.