Dr. John Kellum reports
SPECTRAL MEDICAL ANNOUNCES OPENING OF TIGRIS CLINICAL TRIAL SITE AT THE MAYO CLINIC
Spectral Medical Inc. is on-boarding the Mayo Clinic in Rochester, Minn., as its 19th clinical site for the company's Tigris trial, a phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (PMX) in a randomized controlled trial of adults being treated for endotoxemia and septic shock. The Mayo Clinic is a premier medical centre in the United States and is top ranked in more specialties than any other hospital in the nation, according to U.S. News & World Report.
Dr. John Kellum, chief medical officer of Spectral, commented: "We are pleased to announce the addition of the Mayo Clinic to the premier roster of clinical trial sites participating in Tigris. 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 enrolment rates and preliminary mortality data."
About Spectral Medical Inc.
Spectral is a phase 3 company seeking United States Food and Drug Administration (FDA) approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the company's endotoxin activity assay (EAA), the only FDA-cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the United States for PMX and, in November, 2010, signed an exclusive distribution agreement for this product in Canada. In July, 2022, the U.S. FDA granted breakthrough device designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
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