Pulse Biosciences Hits Its Stride: NANOPULSE‑AF AFib Pivotal Trial Passes Enrollment Midpoint

• The NANOPULSE‑AF study is evaluating the CellFX nano‑second pulsed field ablation (nsPFA) Cardiac Catheter System in people with drug‑resistant, symptomatic paroxysmal atrial fibrillation.
• The trial plans to enroll about 215 participants across multiple centers, with evaluable data expected from roughly 145–155 patients.
• The pivotal study builds on earlier European feasibility data that showed very high procedural success rates and few adverse events.

Pulse Biosciences, Inc. (Nasdaq: PLSE) has passed the enrollment midpoint in its NANOPULSE‑AF pivotal study of the nPulse Cardiac Catheter System for atrial fibrillation, keeping the trial on track for full enrollment around early Q4 2026. This milestone is important because it shows that sites are recruiting patients as planned and that the study is progressing toward key data readouts.

 What the NANOPULSE‑AF study is testing

The NANOPULSE‑AF trial is designed to see whether Pulse Biosciences’ nPulse/CellFX system can safely and effectively treat atrial fibrillation. It enrolls patients whose AF symptoms continue even after they have tried medicines, which means they often need a procedure to correct their heart rhythm. The study focuses on isolating the pulmonary veins, which are a common trigger for AF, and then following patients over time to see how long they stay in rhythm and how safe the procedure is.

 Why the enrollment midpoint matters

Reaching the halfway point in enrollment means that many sites are active and finding suitable patients. It also means that the company can be more confident about hitting its target of finishing enrollment by early Q4 2026. As more patients complete six‑ and twelve‑month follow‑up, Pulse Biosciences will move closer to having the pivotal data it needs for future regulatory discussions. For investors and clinicians, this progress helps confirm that the trial timeline is realistic and that the program continues to advance.

 Link to earlier European results

Before starting this pivotal study, Pulse Biosciences ran a feasibility trial in Europe. In that study, the nPulse system showed high rates of acute procedural success and strong results at one year, with limited side effects. Because those early data looked promising, the company is now testing the system in a larger, more formal U.S. and multicenter pivotal setting. The goal is to show that the same strong outcomes can be repeated in a broader population.

 Why this is meaningful for investors

For shareholders, passing the enrollment midpoint reduces one of the major practical risks in a pivotal trial: slow or stalled recruitment. It also keeps the company on a path where important clinical results could arrive in the next couple of years. If the final data confirm strong safety and long‑lasting rhythm control, Pulse Biosciences’ nsPFA technology could become a notable new option in the growing market for pulsed field ablation in AF.