Pulse Biosciences hits 164-patient enrollment target in NANOPULSE-AF pivotal AF trial, 3 months early

PULSE BIOSCIENCES, INC.

NANOPULSE-AF IDE pivotal study enrolled 164 evaluable patients across 15 clinical sites, evaluating the nPulse Cardiac Catheter System in drug-resistant, symptomatic paroxysmal atrial fibrillation.
Enrollment completed three months ahead of the original 9-month timeline; first patients were treated in April 2026, starting at St. Bernards Medical Center in Jonesboro, Arkansas.
Primary safety and effectiveness endpoints will be assessed at 6 and 12 months post-ablation; Pulse expects to present pivotal data at a future medical society conference.
Vivek Reddy, MD (Mount Sinai Fuster Heart Hospital) serves as national principal investigator; Devi Nair, MD led the first case; CMO David Kenigsberg credited investigator enthusiasm for the pace.

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