TORONTO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the timing of its Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”) for its hemoadsorption device to treat endotoxic septic shock. Following recent interaction with the FDA, the Company now expects to submit its PMA around the end of April to mid-M ...

Core Insights - Spectral Medical Inc. has completed enrollment for its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock, with topline results expected in August 2025 [1][2][3] - The company has entered into a promissory note agreement with Vantive for up to US$10 million to support PMX commercialization [1][9] Clinical Development - The Tigris trial has enrolled a total of 157 patients, with 151 evaluable patients and 100 treated with PMX [6] - The data lock for the trial is expected to be completed in approximately 90 days, with topline results anticipated two weeks post-data lock [6] - The company is on track to submit clinical results to the FDA by the end of October 2025 [6] Financial Performance - Revenue for Q1 2025 was $572,000, a decrease of 14% from $668,000 in Q1 2024 [10] - Operating expenses increased significantly to $13,174,000, up 173% from $4,825,000 in the prior year, primarily due to non-cash fair value adjustments [11] - The company reported a loss of $12,605,000 for Q1 2025, compared to a loss of $4,160,000 in Q1 2024 [13] Balance Sheet and Financing - As of March 31, 2025, the company had cash of $1,670,000, down from $2,988,000 at the end of 2024 [14] - The promissory note with Vantive includes a four-year maturity and a payment-in-kind interest rate of 9% [15] Commercialization Activities - The company is collaborating with Vantive on post-approval marketing plans for PMX commercialization [15] - Vantive intends to submit a 510(k) application for its PrisMax System, which is expected to be the primary device used for PMX treatments upon commercial launch [15] Regulatory and Clinical Study Insights - The EDEN study, completed in Q4 2023, showed that patients with endotoxic septic shock had a significantly higher mortality rate of 60% compared to 14.1% for other septic shock patients [6] - The results from the EDEN study will inform discussions with the FDA regarding PMX labeling and the addressable population in the U.S. [6]