January Update on Spectral Medical's Tigris Trial

Spectral Medical Inc., a company in the final stages of development for sepsis and septic shock treatments, has reported significant progress in its Tigris trial. This Phase 3 study is assessing the effectiveness of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock in adults. The trial has seen a substantial increase in patient enrollment, with 85 participants enrolled so far, including four in January 2024. The company is nearing its interim target of 90 patients, a milestone that could trigger a second payment from Baxter to Spectral for maintaining exclusive PMX distribution rights.

Spectral is also expanding its clinical trial sites, with six new ones being added. The University of Texas Health Sciences Center at Houston has recently joined the trial, and another Texas-based site is expected to follow suit shortly. The company anticipates a busy quarter ahead with site onboarding and training planned for February.

Chris Seto, CEO of Spectral Medical, expressed enthusiasm about the company's prospects, highlighting the importance of reaching the 90-patient enrollment target and the final push to complete the Tigris trial with 65 patients remaining.

Spectral is in the Phase 3 stage, seeking FDA approval in the U.S. for its Toraymyxin™ (PMX) product, which is designed to treat septic shock by removing endotoxin from the bloodstream. The PMX device is already approved for use in Japan and Europe, where it has been safely and effectively used on over 340,000 patients. Spectral obtained exclusive rights for PMX in the U.S. in 2009 and signed a distribution agreement for Canada in 2010. The FDA granted Breakthrough Device Designation for PMX in July 2022, recognizing the significant need for effective treatments, as approximately 330,000 North American patients are diagnosed with septic shock annually.

The Tigris Trial is a crucial study for PMX, comparing its use in conjunction with standard care against standard care alone. It is structured as a 2:1 randomized trial involving 150 patients and employs Bayesian statistics for its methodology. The study aims to confirm the efficacy of PMX in treating a particularly severe form of sepsis known as endotoxic septic shock.