Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on advancing therapeutic options for sepsis and septic shock [1] - The company is seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream [4][5] - PMX has been approved for therapeutic use in Japan and Europe, with over 360,000 applications to date [5] Clinical Trials and Regulatory Status - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, involving 150 patients in a 2:1 randomized trial [6] - The U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock in July 2022 [5] Upcoming Events - Management will participate in a fireside chat at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at Nasdaq headquarters in New York City [1][3] - Investors interested in meeting with the management team can contact their H.C. Wainwright representative [2]