{"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","discovered_at":"2026-05-14T18:03:13.852379+00:00","generated_at":"2026-05-31T10:57:39.037937+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Pulse Biosciences treats first two patients in first-in-human study of nano-PFA Cardiac Surgery System for AFib","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-025296","json":"https://secwatch.observer/filing/0001437749-24-025296.json","markdown":"https://secwatch.observer/filing/0001437749-24-025296.md","text":"https://secwatch.observer/filing/0001437749-24-025296.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T10:57:39.037937+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}