secwatch.observer — SEC 8-K summary
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Issuer:     PULSE BIOSCIENCES, INC. (PLSE)
CIK:        0001625101
Form:       8-K
Filed at:   2024-08-08T23:59:59+00:00
Accession:  0001437749-24-025296
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1625101/000143774924025296/0001437749-24-025296-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1625101/000143774924025296/plse20240802_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-025296

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