Item 8.01 Other Events. On October 7, 2026, Pulse Biosciences, Inc. (the “Company”) announced that it had achieved its enrollment target of 164 evaluable patients in its NANOPULSE-AF clinical study evaluating the Company’s nPulse™ Cardiac Catheter System for the treatment of atrial fibrillation (the “Study”).…
Filed Oct 7, 2026Accepted Oct 7, 2026, 9:06 AM EDTCIK 1625101Accession 0001437749-26-032271
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Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On October 7, 2026, Pulse Biosciences, Inc. (the “Company”) announced that it had achieved its enrollment target of 164 evaluable patients in its NANOPULSE-AF clinical study evaluating the Company’s nPulse™ Cardiac Catheter System for the treatment of atrial fibrillation (the “Study”). The Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the nPulse Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study achieved target enrollment of 164 evaluable participants across 15 clinical sites, with the first patients treated in April 2026. The primary safety and effectiveness endpoints of the Study will be assessed at 6 and 12 months post-ablation.
A copy of the press release related to the matters set forth herein is attached hereto as Exhibit 99.1 and is incorporated herein by reference.