February Tigris Trial Progress Report from Spectral Medical

Spectral Medical Inc., a firm in the final stages of development, is dedicated to improving treatments for sepsis and septic shock. The company has been making significant progress in its Phase 3 Tigris trial, which is assessing the effectiveness of Polymyxin B Hemoperfusion (PMX) in managing endotoxemia and septic shock in adults. The study has seen a strong patient enrollment drive in 2024, with 93 individuals participating so far. February marked a milestone with six new patients joining the study, following the same number in January. This enrollment rate is the highest since the trial began.

The company is now in the final stages of the trial, needing only 57 more patients to reach its target. To maintain this momentum, Spectral plans to convene an Investigator Meeting on March 12th and 13th, coinciding with the 29th International Conference on Advances in Critical Care Nephrology in San Diego.

Currently, there are 21 active sites for the Tigris trial, with ongoing efforts to add four more high-quality clinical locations. The Institute for Extracorporeal Life Support in San Antonio, Texas, has recently signed the trial agreement. Spectral anticipates a busy quarter with significant site onboarding and final training at three of the prospective sites.

Spectral is in the process of seeking FDA approval in the U.S. for its novel product, Toraymyxin™ (PMX), designed to treat septic shock patients. PMX is a therapeutic device that eliminates endotoxin from the bloodstream, a substance that can trigger sepsis, and is guided by the company's Endotoxin Activity Assay (EAA™), an FDA-approved diagnostic for sepsis risk. PMX has already been approved for use in Japan and Europe, where it has been safely and effectively used on over 340,000 patients. In 2009, Spectral secured exclusive rights for PMX's development and commercialization in the U.S., and in 2010, signed a distribution agreement for Canada. In July 2022, the FDA granted Breakthrough Device Designation for PMX for treating endotoxic septic shock, a condition affecting approximately 330,000 North American patients annually.

The Tigris Trial is a crucial study that compares PMX in conjunction with standard care against standard care alone, utilizing Bayesian statistics in a 2:1 randomized trial format. The trial's methodology is outlined in "Bayesian methods: a potential path forward for sepsis trials." Spectral is traded on the Toronto Stock Exchange under the symbol EDT.

It is important to note that the information provided here is based on the current understanding and may be subject to change as new data emerges. The company's future outlook and anticipated events or results are based on assumptions and information available at the time of preparation, which may not prove to be accurate. Actual results could vary significantly due to a range of factors, including the ability to secure funding, the recruitment of additional clinical trial sites, the rate of patient enrollment, and the granting of regulatory approvals, among others.