{"schema_version":"secwatch.filing_event.v1","accession":"0001654954-23-009414","form_type":"8-K","ticker":"TENX","cik":"0000034956","company_name":"TENAX THERAPEUTICS, INC.","filed_at":"2023-07-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.308907+00:00","generated_at":"2026-06-13T06:36:14.514018+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Tenax Therapeutics receives U.S. patent for oral levosimendan (TNX-103) in PH-HFpEF, expiring 2040","bullets":["USPTO granted Patent No. 11,701,355 for oral levosimendan (TNX-103) to treat PH-HFpEF, with exclusivity through December 2040.","No FDA-approved treatments exist for PH-HFpEF, which affects over 1.6 million North Americans, projected to exceed 2 million by 2030.","Phase 2 HELP study showed statistically significant improvement in 6-minute walk distance for levosimendan.","Tenax intends to initiate a Phase 3 trial of TNX-103 in 2023, planning to demonstrate efficacy in this underserved patient population.","Patent builds on existing IP for IV and subcutaneous levosimendan formulations for PH-HFpEF."],"urls":{"canonical":"https://secwatch.observer/filing/0001654954-23-009414","json":"https://secwatch.observer/filing/0001654954-23-009414.json","markdown":"https://secwatch.observer/filing/0001654954-23-009414.md","text":"https://secwatch.observer/filing/0001654954-23-009414.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/34956/000165495423009414/0001654954-23-009414-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/34956/000165495423009414/tenx_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T06:36:14.514018+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"}