Spectral Medical Inc. has announced the opening of a new clinical trial site at the Mayo Clinic in Rochester, Minnesota, for its Tigris trial. This Phase 3 study is evaluating the use of Polymyxin B Hemoperfusion (PMX) in treating adults with endotoxemia and septic shock. The addition of the Mayo Clinic, a leading U.S. medical center, marks a significant step in the trial's progress.
The Tigris trial is a randomized controlled study designed to assess the efficacy of PMX in patients undergoing treatment for endotoxemia and septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin, a causative agent of sepsis, from the bloodstream. The trial is guided by Spectral's Endotoxin Activity Assay (EAA), the only FDA-cleared diagnostic for assessing the risk of developing sepsis.
"We are pleased to announce the addition of the Mayo Clinic to the premier roster of clinical trial sites participating in Tigris," said Dr. John Kellum, Chief Medical Officer of Spectral. "Moreover, we are making continued progress enrolling additional sites, and are on track to add an additional six sites in the coming four to six weeks. We remain highly encouraged by the outlook for the trial, given both the current enrollment rates and preliminary mortality data."
PMX is already approved for therapeutic use in Japan and Europe, where it has been used safely and effectively on over 340,000 patients. Spectral Medical obtained exclusive U.S. development and commercial rights for PMX in March 2009 and signed an exclusive distribution agreement for Canada in November 2010. In July 2022, the FDA granted Breakthrough Device Designation to PMX for treating endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America annually, underscoring the urgent need for innovative treatments.
