Spectral Medical Provides Update on PMA Submission Timing for PMX-20R

Core Viewpoint - Spectral Medical Inc. is updating its timeline for the Premarket Approval (PMA) submission to the FDA for its hemoadsorption device, PMX, aimed at treating endotoxic septic shock, now expected between late April and mid-May 2026, delayed from the previous target of Q1 2026 [2][4] Group 1: PMA Submission Update - The delay in the PMA submission is due to the need to include complete 12-month mortality data from the Tigris study and to finalize certain non-clinical module items, including human factors engineering testing [2][3] - The company anticipates reporting topline 12-month mortality data in late May or early June 2026, pending additional data analysis [3] Group 2: Product and Market Information - PMX is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream and is guided by the FDA-cleared Endotoxin Activity Assay (EAA) [5] - PMX is already approved for therapeutic use in Japan and Europe, licensed by Health Canada, with over 360,000 units sold globally [6] - Approximately 330,000 patients are diagnosed with septic shock annually in North America, highlighting the market potential for PMX [6] Group 3: Clinical Trial Details - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care against standard care alone, designed as a 2:1 randomized trial involving 150 patients [7]