HAYWARD, Calif. — October 7, 2026
Pulse Biosciences announced that its NANOPULSE-AF pivotal clinical study has reached its enrollment target, with 164 evaluable patients enrolled across 15 clinical sites. The multicenter IDE study is evaluating the safety and effectiveness of the company’s nPulse Cardiac Catheter System for the treatment of drug-resistant, symptomatic paroxysmal atrial fibrillation (AF). The enrollment milestone was achieved three months ahead of the company’s original nine-month timeline, marking a key step in the clinical development of the cardiac ablation system. Pulse Biosciences said the enrollment pace reflects strong participation across the clinical sites as the company advances its proprietary nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology toward potential use in atrial fibrillation treatment.
Pivotal Study Evaluates nPulse Cardiac Catheter
The NANOPULSE-AF Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to assess the safety and effectiveness of the nPulse Cardiac Catheter System in patients with drug-resistant, symptomatic paroxysmal AF. The study enrolled 164 evaluable participants across 15 clinical centers in the United States. The first patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of principal investigator Devi Nair, M.D., while Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital, serves as National Principal Investigator. Pulse Biosciences said primary endpoints will be evaluated at six and 12 months following ablation, with assessments focused on procedural success and safety outcomes. The company plans to provide additional updates as patients progress through follow-up.
nsPFA Technology Supports Non-Thermal Ablation
The nPulse Cardiac Catheter System is based on Pulse Biosciences’ proprietary Nanosecond Pulsed Field Ablation technology, which delivers extremely short electrical pulses intended to non-thermally clear targeted cells while sparing adjacent non-cellular tissue. The company is developing the technology as an alternative approach for cardiac ablation procedures in atrial fibrillation. Investigators involved in the NANOPULSE-AF study have highlighted the catheter’s procedural workflow and early clinical experience, including its designed one-shot approach. However, the current pivotal study is intended to generate the controlled clinical evidence needed to evaluate the system’s safety and effectiveness. Pulse Biosciences said the rapid enrollment across 15 centers provides a foundation for completing patient follow-up and assessing the study’s predefined clinical endpoints.
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Pulse Biosciences Advances Clinical Development
With enrollment now complete, the company is moving into the patient follow-up phase of the NANOPULSE-AF pivotal program. Pulse Biosciences expects to present pivotal study data at a future medical society conference after patients complete the required follow-up assessments. The company said the enrollment target was reached significantly ahead of its original timeline, with participation from all 15 clinical centers. The progress represents an important development milestone for the nPulse Cardiac Catheter System as Pulse Biosciences works toward generating clinical evidence for its nsPFA technology in atrial fibrillation. The company is also pursuing applications of its proprietary bioelectric medicine platform in selected additional therapeutic areas, but the NANOPULSE-AF study remains a central clinical program for evaluating the technology in cardiac care.
Source::Pulse Biosciences, press release
