{"schema_version":"secwatch.filing_event.v1","accession":"0001563665-22-000023","form_type":"8-K","ticker":"HRGN","cik":"0001563665","company_name":"Harvard Apparatus Regenerative Technology, Inc.","filed_at":"2022-12-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.174778+00:00","generated_at":"2026-06-20T22:27:04.236177+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":"Biostage selects IQVIA as CRO for FDA-approved esophageal implant trial","bullets":["IQVIA, a global CRO with GI and cell-therapy trial experience, to manage Biostage's first clinical trial.","Trial is FDA-approved open-label study for up to 10 patients requiring removal of up to 6cm esophagus (cancer, trauma, birth defects).","Primary endpoint: continuous biological conduit at 3 months; first human use met endpoint by 1 month (JTO CRR, Aug 2021).","Preliminary contract covers first stage; second comprehensive contract expected. Trial duration 4-6 years with staggered enrollment and 2-year follow-up.","CEO: current 5-year survival for esophageal cancer only 20%; >600k new cases annually worldwide."],"urls":{"canonical":"https://secwatch.observer/filing/0001563665-22-000023","json":"https://secwatch.observer/filing/0001563665-22-000023.json","markdown":"https://secwatch.observer/filing/0001563665-22-000023.md","text":"https://secwatch.observer/filing/0001563665-22-000023.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/0001563665-22-000023-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563665/000156366522000023/tmb-20221228x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T22:27:04.236177+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"}