secwatch.observer — SEC 8-K summary
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Issuer:     PULSE BIOSCIENCES, INC. (PLSE)
CIK:        0001625101
Form:       8-K
Filed at:   2025-10-24T23:59:59+00:00
Accession:  0001437749-25-031680
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Pulse Biosciences enrolls first patient in NANOCLAMP AF study for AF treatment using nPulse system
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- First procedure completed at St. Helena Hospital in St. Helena, CA with nPulse Cardiac Surgical System using nanosecond PFA.
- NANOCLAMP AF is a single-arm, prospective multicenter study for safety/effectiveness of nPulse in concomitant AF procedures.
- nPulse system granted FDA Breakthrough Device Designation in July 2024 and enrolled in FDA's TAP program.
- Multiple U.S. and two international sites planned; study follows recent FDA IDE approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1625101/000143774925031680/0001437749-25-031680-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1625101/000143774925031680/plse20251024_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-031680

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