This analyst loves Spectral Medical

Research Capital analyst Andre Uddin maintained his “Speculative Buy” rating and C$3.50 price target on Spectral Medical (Spectral Medical Stock Quote, Chart, News, Analysts, Financials TSX:EDT) following an update on the company’s planned U.S. regulatory submission.

In a Feb. 26 note, Uddin said the company intends to strengthen its premarket approval (PMA) filing package with the U.S. Food and Drug Administration by including a small human factors study and 12-month durability and mortality data from its pivotal Tigris trial.

The human factors study is expected to evaluate the usability of the PMX columns by 15 clinicians in a simulated hospital setting following the instructions for use. Uddin described the study as straightforward and not expected to materially impact operating expenses.

He views the 12-month Tigris data as potentially more significant, saying robust long-term data should enhance regulatory confidence and support clinician adoption. Topline 12-month results are expected by May or June 2026, with peer-reviewed publication targeted for September 2026. The current Tigris dataset is anticipated to be published by March 21, followed by presentation at the Society of Critical Care Medicine conference in Chicago.

Uddin now expects the PMA filing to occur by mid-May 2026, compared with a prior expectation of Q1 2026, implying a potential U.S. launch in 2027 following a 180- to 270-day FDA review. While this pushes the expected launch timeline into 2027 from late 2026, he said a comprehensive data package is critical for both regulators and clinicians.

As a result, Uddin has removed initial PMX sales from his 2026 forecast but maintained his 2027 U.S. sales projections and net present value valuation, reflecting expectations for rapid adoption following approval.

Spectral Medical is a Canadian medical device company focused on theranostics, a precision medicine approach that combines diagnostic testing with targeted treatment. Its lead therapy, Toraymyxin (PMX), is a therapeutic device designed to treat endotoxic septic shock.

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