secwatch.observer — SEC 8-K summary
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Issuer:     PULSE BIOSCIENCES, INC. (PLSE)
CIK:        0001625101
Form:       8-K
Filed at:   2026-02-06T23:59:59+00:00
Accession:  0001437749-26-003256
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Pulse Biosciences reports 96% procedural success at 12 months for nPulse AF ablation study
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- 100% procedural success at 6 months (75/75); 96% at 12 months (45/47) in first-in-human feasibility study.
- Average procedure time 65 ± 28 min; left atrial dwell time 21 ± 13.3 min; fluoroscopy 9.8 ± 5.8 min.
- Safety: 1.3% (2/150) subjects had a serious adverse event related to primary safety endpoint.
- Data presented at AF Symposium 2026 by Dr. Vivek Reddy; 165 patients treated across 9 European sites.
- Company plans to initiate pivotal IDE study in Europe and U.S. following these results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1625101/000143774926003256/0001437749-26-003256-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1625101/000143774926003256/plse20260204_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-003256

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