{"filing":{"accession_number":"0001193125-26-392088","cik":"0001674632","ticker":"BBNX","company_name":"Beta Bionics, Inc.","form":"8-K","filing_date":"2026-09-15","report_date":"2026-09-14","primary_document":"d153052d8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1674632/000119312526392088/d153052d8k.htm"},"events":[{"id":33677,"run_id":30977,"accession_number":"0001193125-26-392088","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.74,"summary":"Beta Bionics announced FDA clearance of Mint, a patch pump product, and submission of a 510(k) application for 3D Intelligence, its next-generation insulin dosing algorithm. The company provided commercialization timelines (Q1 2027 for Mint, end of 2026 for iLet 3D), manufacturing capacity expectations (1.5 million units in 2027), and revised 2026 revenue guidance downward to $121–$126 million from $131–$136 million.","company_name":"Beta Bionics, Inc.","ticker":"BBNX","filing_date":"2026-09-15","form":"8-K","submitted_at":null,"items":[{"id":37191,"accession_number":"0001193125-26-392088","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Beta Bionics announced FDA clearance of Mint, a patch pump product, and submission of a 510(k) application for 3D Intelligence, its next-generation insulin dosing algorithm. The disclosure includes commercialization timelines (Q1 2027 for Mint, end of 2026 for iLet 3D), manufacturing capacity expectations (1.5 million units in 2027), and updated 2026 revenue guidance ($121–$126 million, down from $131–$136 million). This is a material regulatory milestone and product launch announcement affecting the company's near-term commercial trajectory and financial outlook, but does not fit neatly into specific categories like earnings_release (no actual results), ma_activity, or debt/capital events. The operational and strategic significance—FDA clearance, product launch timing, manufacturing scale-up, and revenue guidance revision—makes this an operational_other event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-15T21:01:07.207156+00:00","company_name":"","ticker":null,"filing_date":""},{"id":37192,"accession_number":"0001193125-26-392088","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.72,"reasoning":"The Item 8.01 disclosure centers on FDA clearance of Mint (a new patch pump product) and submission of a 510(k) application for 3D Intelligence (a next-generation algorithm), along with expected commercialization timelines and manufacturing capacity. While the filing also includes a securities class action lawsuit disclosure, the dominant operational content is the product regulatory milestone and commercial launch plan. This is a material operational/strategic event affecting the company's product portfolio and market expansion, but does not fit neatly into specific categories like ma_activity or earnings_release; operational_other best captures a material product launch and regulatory milestone.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-15T21:01:07.207156+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":37191,"accession_number":"0001193125-26-392088","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Beta Bionics announced FDA clearance of Mint, a patch pump product, and submission of a 510(k) application for 3D Intelligence, its next-generation insulin dosing algorithm. The disclosure includes commercialization timelines (Q1 2027 for Mint, end of 2026 for iLet 3D), manufacturing capacity expectations (1.5 million units in 2027), and updated 2026 revenue guidance ($121–$126 million, down from $131–$136 million). This is a material regulatory milestone and product launch announcement affecting the company's near-term commercial trajectory and financial outlook, but does not fit neatly into specific categories like earnings_release (no actual results), ma_activity, or debt/capital events. The operational and strategic significance—FDA clearance, product launch timing, manufacturing scale-up, and revenue guidance revision—makes this an operational_other event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-15T21:01:07.207156+00:00","company_name":"Beta Bionics, Inc.","ticker":"BBNX","filing_date":"2026-09-15"},{"id":37192,"accession_number":"0001193125-26-392088","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.72,"reasoning":"The Item 8.01 disclosure centers on FDA clearance of Mint (a new patch pump product) and submission of a 510(k) application for 3D Intelligence (a next-generation algorithm), along with expected commercialization timelines and manufacturing capacity. While the filing also includes a securities class action lawsuit disclosure, the dominant operational content is the product regulatory milestone and commercial launch plan. This is a material operational/strategic event affecting the company's product portfolio and market expansion, but does not fit neatly into specific categories like ma_activity or earnings_release; operational_other best captures a material product launch and regulatory milestone.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-15T21:01:07.207156+00:00","company_name":"Beta Bionics, Inc.","ticker":"BBNX","filing_date":"2026-09-15"}]}