April 10, 2024 Tigris Trial Progress Report

Spectral Medical Inc., a company dedicated to developing therapeutic solutions for sepsis and septic shock, has reported significant progress in its Phase 3 Tigris trial. The trial is assessing the efficacy of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock among adults. As of the latest update, 101 patients have been enrolled, with a notable surge in participation during the first quarter of 2024.

The Tigris trial is approaching its full capacity with only 49 more patients needed for completion. To maintain this momentum, Spectral organized an Investigator Meeting in San Diego, which was attended by key stakeholders including principal investigators, clinical research coordinators, and representatives from the company's strategic partner, Baxter.

Currently, there are 22 active trial sites, with efforts underway to add two more high-quality clinical sites. The clinical team at Spectral is focused on supporting these sites to ensure efficient patient enrollment.

Spectral is in the final stages of seeking U.S. FDA approval for its innovative product, Toraymyxin™ (PMX), designed to treat septic shock by removing endotoxins from the bloodstream. This therapeutic hemoperfusion device is already approved for use in Japan and Europe, where it has been utilized in over 340,000 patients. In 2009, Spectral secured exclusive rights for PMX in the U.S., and in 2022, the FDA granted it Breakthrough Device Designation for treating endotoxic septic shock.

The Tigris Trial is a pivotal study comparing PMX in conjunction with standard care against standard care alone, employing Bayesian statistics and a 2:1 randomization of 150 patients. The study aims to address endotoxic septic shock, a severe form of sepsis that affects approximately 330,000 North American patients annually.