• Spectral Medical's Tigris trial, evaluating Polymyxin B Hemoperfusion (PMX) for endotoxemia and septic shock, has enrolled 146 patients, showing strong progress.
• Enrollment in December 2024 saw improvement as intravenous fluid supply issues eased, contributing to a robust overall enrollment for the year.
• The company projects full enrollment of 150 patients by the end of the first quarter of 2025, moving closer to potential FDA approval.
• PMX has received Breakthrough Device Designation from the FDA and is already approved for use in Japan and Europe, marking a significant step in sepsis treatment.