{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-392088","form_type":"8-K","ticker":"BBNX","cik":"0001674632","company_name":"Beta Bionics, Inc.","filed_at":"2026-09-15T20:58:41+00:00","discovered_at":"2026-09-15T20:59:09.369325+00:00","generated_at":"2026-09-15T20:59:20.831182+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA clears Beta Bionics Mint patch pump; 3D Intelligence 510(k) submitted","bullets":["Mint FDA clearance announced Sept 14, 2026; full U.S. launch expected Q1 2027, ahead of prior target; at least 1.5M disposable units capacity in 2027.","510(k) for 3D Intelligence insulin-dosing algorithm submitted; if cleared, powers iLet 3D by end 2026 and Mint 3D at launch.","Mint launches exclusively via pharmacy channel; ~40% insured U.S. lives at launch, rising to ≥50% within first year.","Real-world iLet data: >84% users meet ADA hypoglycemia goals; average HbA1c 8.9% to GMI 7.3% (n=14,952).","Securities class action filed Sept 4, 2026 (Holtzman vs. Beta Bionics) alleging misstatements on iLet; company to defend vigorously."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-392088","json":"https://secwatch.observer/filing/0001193125-26-392088.json","markdown":"https://secwatch.observer/filing/0001193125-26-392088.md","text":"https://secwatch.observer/filing/0001193125-26-392088.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1674632/000119312526392088/0001193125-26-392088-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1674632/000119312526392088/d153052d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-15T20:59:20.831182+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"}