{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-101763","form_type":"8-K","ticker":"OBIO","cik":"0001814114","company_name":"Orchestra BioMed Holdings, Inc.","filed_at":"2023-09-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:35.377604+00:00","generated_at":"2026-06-10T13:44:10.934818+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA grants IDE approval for Orchestra BioMed's BACKBEAT pivotal study of BackBeat CNT in hypertensive pacemaker patients","bullets":["FDA approved IDE for global pivotal BACKBEAT study evaluating AVIM therapy (BackBeat CNT) for hypertension in pacemaker patients.","Study to randomize ~500 patients 1:1, primary endpoint: change in mean 24-hour ambulatory systolic BP at 3 months.","Orchestra BioMed collaborating with Medtronic; Medtronic has exclusive global commercialization rights if approved.","Supported by MODERATO II pilot study: net reduction of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in oSBP at 6 months.","Enrollment expected to start before end of 2023; study designed to support future regulatory review and potential approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-101763","json":"https://secwatch.observer/filing/0001104659-23-101763.json","markdown":"https://secwatch.observer/filing/0001104659-23-101763.md","text":"https://secwatch.observer/filing/0001104659-23-101763.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1814114/000110465923101763/0001104659-23-101763-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1814114/000110465923101763/tm2326382d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T13:44:10.934818+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"}