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Spectral Medical Inc. Announces Results of Annual Meeting of Shareholders
Globenewswire· 2025-06-06 14:59
Core Points - Spectral Medical Inc. held its Annual Meeting of shareholders on June 5, 2025, where all resolutions in the Management Information Circular were approved [1][2] Group 1: Election of Directors - Seven director nominees were elected with high approval rates, including Jan D'Alvise (99.78%), Jun Hayakawa (99.79%), and David W. Feigal, Jr. (99.67%) [3] Group 2: Appointment of Auditors - MNP LLP was re-appointed as the auditor of Spectral with 99.95% votes in favor [4] Group 3: Company Overview - Spectral is a Phase 3 company seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device for treating septic shock [4][5] - PMX has been approved for use in Japan and Europe, with over 360,000 applications to date [5] - The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 for endotoxic septic shock treatment [5] Group 4: Clinical Trials - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial of 150 patients [6]
Spectral Medical Provides February Tigris Trial Update
Globenewswire· 2025-03-03 13:00
Core Insights - Spectral Medical Inc. is advancing its Tigris trial, a Phase 3 study evaluating Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock [2][4] - The company aims to finalize full enrollment of 150 evaluable patients by the end of March 2025, with 152 patients already enrolled [8] Enrollment Update - As of now, 152 patients have been enrolled in the Tigris trial, with six patients enrolled in February [8] - The trial is designed to randomize 150 patients in a 2:1 ratio, with 100 patients receiving PMX and 50 receiving standard care [6][8] - The company estimates that an additional four to seven patients are needed to reach the target of 150 evaluable patients [8] Product and Market Context - PMX is already approved for therapeutic use in Japan and Europe, having been safely used on over 340,000 patients [5] - Approximately 330,000 patients are diagnosed with septic shock annually in North America, highlighting the market potential for PMX [5]