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Spectral Medical and Vantive Release Topline Results From Phase 3 Endotoxic Septic Shock Study
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Spectral Medical and Vantive Release Topline Results From Phase 3 Endotoxic Septic Shock Study
Aug 12, 2025 1:55 PM

04:39 PM EDT, 08/12/2025 (MT Newswires) -- Spectral Medical ( EDTXF ) and Vantive on Tuesday afternoon released top-line results from the Tigris trial, a phase 3 study testing Polymyxin B Hemoadsorption (PMX) in adults with endotoxic septic shock.

The trial included 157 patients who were randomly assigned to receive either PMX plus standard care or standard care alone, according to the statement.

The companies said the results exceed the trial's primary endpoint, showing a 95% plus probability that PMX improves survival at 28 days. PMX also led to an 8.3% absolute reduction and an 18% relative reduction in the risk of death at 28 days.

The study also met a key secondary endpoint. At 90 days, mortality was 17.4% lower in the PMX group, with a greater than 99% chance that the treatment was beneficial, the companies added.

Vantive is the exclusive distributor of PMX in the United States and Canada and has global, non-exclusive rights to sell the Endotoxin Activity Assay (EAA). Spectral plans to submit the final part of its Food and Drug Administration application for PMX by the end of October. If approved, Vantive will launch both PMX and EAA in the U.S. as part of its Targeted Rapid Endotoxin Adsorption Therapy, the companies said.

Spectral shares closed up $0.01 to $0.82 on the Toronto Stock Exchange.

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