---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-025296"
form_type: "8-K"
ticker: "PLSE"
cik: "0001625101"
company_name: "PULSE BIOSCIENCES, INC."
filed_at: "2024-08-08T23:59:59+00:00"
generated_at: "2026-05-31T10:57:39.037937+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Pulse Biosciences treats first two patients in first-in-human study of nano-PFA Cardiac Surgery System for AFib

## Summary
- Successfully treated first two AFib patients using nano-PFA Cardiac Surgery System at St. Antonius Hospital, Netherlands.
- Feasibility study is multicenter, up to 30 patients, with chronic isolation confirmed at ~3 months via catheter remapping.
- Cardiac Surgery System enrolled in FDA's TAP program and holds Breakthrough Device Designation (granted July 2024).
- Plans to submit IDE for U.S. clinical work and begin pivotal study in early 2025, pursuing PMA for commercialization.

## SEC filing metadata
- accession: 0001437749-24-025296
- form_type: 8-K
- ticker: PLSE
- cik: 0001625101
- company_name: PULSE BIOSCIENCES, INC.
- filed_at: 2024-08-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1625101/000143774924025296/0001437749-24-025296-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1625101/000143774924025296/plse20240802_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-025296
- JSON: https://secwatch.observer/filing/0001437749-24-025296.json
- Plain text: https://secwatch.observer/filing/0001437749-24-025296.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.