Provenance Record

Well structured (Overview / What We Know / What We Don't Know / Context). Neutral, professional tone. Appropriate length for Briefing (~630 words). The 'What We Don't Know' section honestly enumerates the open questions (single-center identity, immunosuppression regimen, surgery timeline, registrational-stage transition).

{"source-0":{"url":"https://ir.unither.com/press-releases/2026/05-15-2026-230017490","snapshot":"source-0.html.gz","status":"Primary UTHR IR release. All article specifics verified verbatim. Allowlist warning is operational only — ir.unither.com is the company's official investor-relations subdomain."},"source-1":{"url":"https://www.stocktitan.net/news/UTHR/united-therapeutics-corporation-announces-fda-clearance-to-proceed-7ylp2p7djkmd.html","snapshot":"source-1.html.gz","status":"Financial wire mirror of the UTHR press release. Used for the Byrd quote citation; full quote text verified verbatim. Allowlist warning operational only."},"source-2":{"url":"https://www.statnews.com/2025/02/03/united-therapeutics-xenotransplantation-clinical-trial/","snapshot":"source-2.html.gz","status":"STAT historical (Feb 3 2025) coverage of the UKidney IND clearance. Verifies the 'compassionate-use waivers' framing the article uses and the 'first xenotransplantation clinical trial' characterization."},"source-3":{"url":"https://ir.unither.com/press-releases/2025/02-03-2025-120011819","snapshot":"source-3.html.gz","status":"Original UTHR UKidney IND release (Feb 3 2025 per URL path). Verifies the 'phaseless' design language and supports the article's framing of the prior trial."}}

Exemplary submission. Every specific verified verbatim against the official UTHR investor-relations press release (source-0): EXPRESS trial name, UHeart, May 15 2026 date, single-center start, two-participant initial cohort, 12-week follow-up gate, independent DMC, phase 1/2/3 'phaseless' design, ≥50 years age criterion, ACC/AHA stage D + NYHA Class IV, LVEF + global longitudinal strain + RV free-wall strain endpoints, 24-week QoL, 6-minute walk distance, 10 gene edits (6 human added + 4 porcine knocked out), and both direct quotes (DeSmet 'Moving a porcine-derived heart...' and Byrd 'Patients with end stage heart disease...') character-for-character verbatim. The UKidney February 2025 cross-reference is correctly sourced to source-3 (the actual Feb 3 2025 UTHR release). Internal cross-reference to 2026-03/23-organ-transplant-medicine... verified to exist.