Spectral Medical Announces Major Milestone by Reaching Its Interim Enrollment Target of 90 Patients

Core Insights - Spectral Medical Inc. has achieved a significant milestone by reaching its Interim Enrollment target of 90 patients in the TIGRIS trial, which is crucial for the development of its product PMX for treating septic shock [1][2] - Baxter International has the option to make a second milestone payment to Spectral to maintain its exclusive distribution rights for PMX following this enrollment milestone [1] Company Overview - Spectral is a late-stage theranostic company focused on advancing therapeutic options for sepsis and septic shock, with its product Toraymyxin™ (PMX) being a therapeutic hemoperfusion device that removes endotoxin from the bloodstream [3] - PMX is already approved for therapeutic use in Japan and Europe, having been safely and effectively used on over 340,000 patients [3] - The company has exclusive development and commercial rights for PMX in the U.S. since March 2009 and signed an exclusive distribution agreement for Canada in November 2010 [3] TIGRIS 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 [4] - The trial employs Bayesian statistics to analyze the results, which is a novel approach in sepsis trials [4]