secwatch.observer — SEC 8-K summary
======================================

Issuer:     PULSE BIOSCIENCES, INC. (PLSE)
CIK:        0001625101
Form:       8-K
Filed at:   2026-10-07T13:06:30+00:00
Accession:  0001437749-26-032271
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1625101/000143774926032271/0001437749-26-032271-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1625101/000143774926032271/plse20261002_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-032271

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer