Is Spectral Medical a buy?

Research Capital analyst Andre Uddin maintained a “Speculative Buy” rating and C$3.50 target on Spectral Medical (Spectral Medical Stock Quote, Chart, News, Analysts, Financials TSX:EDT) following publication of the company’s TIGRIS septic shock study in The Lancet Respiratory Medicine.

In a March 24  note, Uddin described the data as exceptionally strong after Spectral announced full publication of the TIGRIS results and presented the study at the Society of Critical Care Medicine Congress in Chicago.

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

The TIGRIS trial evaluated PMX, Spectral’s treatment for endotoxin-driven septic shock, comparing standard care plus PMX against standard care alone in a 2:1 randomized study of 150 patients using a Bayesian statistical framework.

Uddin noted the study met its primary endpoint, with the 28-day mortality analysis showing a 95.3% probability of benefit and an adjusted absolute risk reduction of 10.3%. The key secondary endpoint at 90 days showed a 99.4% probability of benefit for patients treated with PMX.

He added that survival over 90 days was significantly better in the PMX arm, with a posterior hazard ratio of 0.68 and a 98.8% probability of benefit.

Uddin said the safety profile also remained clean, with serious adverse events reported in 30% of PMX-treated patients versus 22% in the standard-care group, a difference he said was not statistically significant.

The published data also highlighted the severity of septic shock, with many patients still hospitalized at 28 days, while 90-day outcomes offered a clearer picture of the therapy’s impact as most surviving patients had been discharged and organ dysfunction had largely resolved.

Uddin said that is one reason the upcoming one-year TIGRIS data, expected in Q2 2026, will be important. He expects that data to be included in Spectral’s planned U.S. FDA premarket approval filing for PMX in Q2 2026.

PMX is a single-use blood purification device designed to remove endotoxin from the bloodstream and is paired with Spectral’s Endotoxin Activity Assay, which is already cleared by the FDA. Vantive is Spectral’s exclusive partner for distributing PMX in the U.S. and Canada.

Uddin said the publication and conference presentation add support to the regulatory case and reinforce the investment thesis ahead of the expected FDA filing.

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