{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-015795","form_type":"8-K","ticker":"HIND","cik":"0001427570","company_name":"Vyome Holdings, Inc","filed_at":"2026-02-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.058684+00:00","generated_at":"2026-05-16T02:45:24.655457+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Vyome reports positive Phase 2 data for VT-1953 in malignant fungating wounds; primary endpoint met","bullets":["VT-1953 achieved significant reduction in malodor at Day 14 (p=0.002 vs baseline; p=0.0015 vs vehicle).","Secondary endpoint met: patient-reported impact of malodor on QoL improved significantly (p=0.0256 vs vehicle).","Exploratory endpoints showed significant pain reduction (p=0.002) and improved composite QoL at Day 14.","No treatment-emergent adverse events or safety signals reported across the 15-patient study.","Company filed for orphan drug designation and plans to discuss Phase 3 design with FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-015795","json":"https://secwatch.observer/filing/0001213900-26-015795.json","markdown":"https://secwatch.observer/filing/0001213900-26-015795.md","text":"https://secwatch.observer/filing/0001213900-26-015795.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1427570/000121390026015795/0001213900-26-015795-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1427570/000121390026015795/ea0276975-8k_vyome.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T02:45:24.655457+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"}