This Canadian company is making advances in septic shock treatment

Paradigm Capital analyst Scott McAuley says the publication of Spectral Medical’s (Spectral Medical Stock Quote, Chart, News, Analysts, Financials TSX:EDT) TIGRIS study in The Lancet Respiratory Medicine adds credibility to the company’s lead septic shock program and could help broaden awareness among both clinicians and investors.

In a March 24 note, McAuley described the development as positive after Spectral and Vantive jointly announced the full TIGRIS results had been published in the peer-reviewed journal and were also being presented at the Critical Care Congress, the annual meeting of the Society of Critical Care Medicine.

“Peer-reviewed publication provides independent validation of the trial results,” McAuley said. “Both the paper and the presentation will help spread the word on the clinical impact of PMX to both clinicians and investors.”

Spectral is a clinical-stage medical device company developing therapies for critical care, with a focus on septic shock and dialysis.

McAuley said the congress is a strong venue for the presentation given its standing as one of the top critical care meetings globally, while the joint release with Vantive underscores the strategic importance of PMX. He also noted the paper is open access, making the data easier to distribute and review ahead of an expected FDA submission in mid-May.

According to McAuley, the published results were broadly in line with the topline data released earlier. After adjusting for baseline patient severity, the study showed an absolute reduction in mortality risk of 10.3% at 28 days and 15.5% at 90 days. The main statistical endpoint was also met, with a 95.3% probability of benefit at 28 days and 99.4% at 90 days, exceeding the trial’s pre-specified threshold.

He said one notable addition in the paper is a survival chart showing the treatment and control groups diverging after the first two weeks, with outcomes stabilizing in the PMX arm while the standard-care arm continued to worsen.

McAuley added that the publication also helps address questions around the use of prior trial data in the analysis. Patient characteristics between the earlier EUPHRATES study and TIGRIS were highly similar, supporting the combined analysis. Even excluding the earlier data, the 90-day mortality result still remained above the key threshold.

“So, for anyone who has issues with including the prior data, this new analysis shows that you don’t need it to see a meaningful mortality benefit,” he said.

He also highlighted additional data showing PMX-treated patients were 33% less likely to remain in the ICU after 28 days and that the treatment’s number needed to treat was 6.5, which he described as a strong result relative to many standard medical practices.

McAuley said publication in The Lancet Respiratory Medicine should carry weight with the target physician audience and adds further support as Spectral moves toward its next regulatory milestones.

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