{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-009304","form_type":"8-K","ticker":"HSDT","cik":"0001610853","company_name":"Solana Co","filed_at":"2025-07-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.481511+00:00","generated_at":"2026-05-18T05:06:46.808897+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Helius Medical reports positive PoNS Stroke Registrational Program results; FDA submission planned","bullets":["Double-blind RCT met primary endpoint: statistically significant improvements in gait/balance with active PoNS therapy (with/without open-label data).","159 patients enrolled across three studies; 130 completed 12-week treatment and follow-up at 10 US/Canada sites.","Minimal adverse events and good tolerability confirmed; key secondary endpoints on fall risk and durability met.","Company plans FDA submission for gait/balance deficit indication in chronic stroke under Breakthrough Device Designation."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-009304","json":"https://secwatch.observer/filing/0001558370-25-009304.json","markdown":"https://secwatch.observer/filing/0001558370-25-009304.md","text":"https://secwatch.observer/filing/0001558370-25-009304.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1610853/000155837025009304/0001558370-25-009304-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1610853/000155837025009304/hsdt-20250721x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T05:06:46.808897+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"}