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8-KAccepted Oct 7, 9:06 AM ET

Pulse Biosciences, Inc.: achieves enrollment target of 164 patients

PLSEPULSE BIOSCIENCES, INC.

Accepted (ET)

9:06 AM

Oct 7, 2026

Filed

Oct 7, 2026

Documents

13

Size

174.7 KB

Summary

Pulse Biosciences, Inc.: achieves enrollment target of 164 patients

Updated

What happened On Oct 7, 2026, Pulse Biosciences, Inc. announced that it had achieved its enrollment target of 164 evaluable patients in its NANOPULSE-AF clinical study evaluating the nPulse™ Cardiac Catheter System for the treatment of atrial fibrillation. The Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate safety and effectiveness in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The Study enrolled 164 evaluable participants across 15 clinical sites, with the first patients treated in Apr 2026. The primary safety and effectiveness endpoints will be assessed at 6 and 12 months post-ablation.

Key details

  • enrollment target: 164 evaluable participants.
  • study sites: 15 clinical sites.
  • first treatments: Apr 2026.
  • endpoints timing: primary safety and effectiveness assessed at 6 and 12 months post-ablation.

Why it may matter The filing reports Item 8.01 (other events) regarding completion of enrollment in the NANOPULSE-AF Study and attaches a related press release as Exhibit 99.1. A filing does not show why the insider traded or why the company acted.

AI-written summary · check the filing