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Biotech / Medical : Spectral Medical Inc.

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From: Sultan	4/28/2025 2:12:40 PM
	of 504

The TIGRIS Trial is a confirmatory study of Toraymyxin™ PMX Hemoperfusion in addition to standard care vs standard care alone in patients with endotoxemic septic shock. Study Design: The study was a 2:1 randomized trial that enrolled 150 patients, utilizing a Bayesian statistical approach. Patients in critical care units were evaluated for septic shock based on key criteria, including known or suspected infection, multiple organ failure, adequate fluid resuscitation, and hypotension requiring vasopressor support. Eligibility for the study required an endotoxin activity level (EAA) between =0.60 and <0.90. Enrollment Complete • 157 patients enrolled • 151 evaluable patients, with 100 treated using PMX • 28-day follow-up for the final patient to be completed by May 8, 2025 Topline Results Timing • Data lock expected approximately 90 days after the final 28-day follow-up • Topline results anticipated about 2 weeks following data lock PMA Submission Progress • Utilizing a modular submission strategy, all non-clinical modules have been submitted to the FDA • Clinical data submission on track for end of October 2025 By refining patient selection and building on insights from previous studies, TIGRIS aims to further define the role of targeted endotoxin removal in improving clinical outcomes for patients with endotoxic septic shock.

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