The first seven patients in this study were treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Devi Nair, MD, Principal Investigator of the Arrhythmia Research Group. "This is a promising technology, and our team is pleased to have enrolled and treated the first patients in this pivotal trial," said Dr. Nair. "The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user-friendly experience and supports an efficient, reproducible and streamlined workflow. This approach may potentially offer important advantages compared with existing technologies. I look forward to continued enrollment and further clinical evaluation of this strategy in atrial fibrillation ablation for the betterment of all involved."

"Enrolling the first patients in this study marks an important milestone for the Company as we build on the encouraging results from our impressive feasibility experience," said Darrin Uecker, CTO and Board Member. "With our nanosecond pulsed field ablation technology and the cardiac catheter's novel design, we are advancing an entirely differentiated approach that we intend to significantly alter AF treatments. We're thrilled by this strong start to the NANOPULSE-AF study and look forward to its rapid expansion."

This milestone builds on Pulse Biosciences' first-in-human feasibility study, which showed 96% procedural success at 12 months and 100% acute success, exceeding expectations in a field where 20-25% recurrence is typical. Outcomes were reproducible across operators and achieved without anti-arrhythmic drugs.

"I am excited to initiate our IDE study with Dr. Nair, a leader in the EP ablation space. This marks an important advancing next step in the clinical development of our nanosecond PFA platform," said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. "Building on encouraging first-in-human data demonstrating safety, procedural efficiency, durable pulmonary vein isolation, and ease of use, our catheter is now tightly integrated with the Abbott EnSite X 3D electroanatomical mapping system, enabling accurate catheter visualization, navigation and contact assessment to support optimal PFA delivery. We look forward to rigorously evaluating this technology in this larger, multicenter setting at up to 30 centers in the United States and Europe."

Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY is the Principal Investigator of the NANOPULSE-AF Study. "From the initial clinical experience, the nPulse™ system demonstrated meaningful potential in the treatment of atrial fibrillation," said Dr. Reddy. "The NANOPULSE‑AF pivotal trial represents an important step forward in evaluating this technology and its potential role in improving procedural outcomes for patients with atrial fibrillation."

The nPulse Cardiac™ Catheter System delivers energy in billionths of a second — nanoseconds — compared with conventional, slower microsecond-based systems. This ultra-fast, non-thermal energy is designed to create precise, durable PVI while minimizing impact to surrounding cardiac structures.

Key design features of the System include:

  • Precise Lesion Formation: Creates deep, circumferential lesions without stacking applications or rotating the catheter.
  • Efficient Workflow: Isolates pulmonary veins with minimal applications and ultra-fast delivery (~5 seconds per application).
  • Procedure Efficiency: Prior feasibility study showed median left atrial dwell time of 21 minutes and total procedure time of approximately 65 minutes.
  • Enhanced Visualization: Integrated magnetic EP mapping with catheter-embedded sensors compatible with Abbott's EnSite X system for real-time 3D electroanatomical visualization to provide a stable location reference, constructing anatomical shells, and standardizing electrophysiological maps to guide therapy.

About the NANOPULSE-AF Study

The NANOPULSE-AF Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the CellFX nsPFA Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study plans to enroll approximately 215 participants across multiple clinical sites, with the first patients treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Dr. Nair. Primary endpoints will be assessed at 6 and 12 months post-ablation to measure procedural success and safety outcomes, supporting the broader clinical development of the nPulse™ system.