Spectral Medical Provides Update on Favorable Tigris Clinical Trial Enrollment

Reports significant uptick in enrollment activities

Tigris trial enrollment at 61 patients

TORONTO, May 30, 2023 (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 enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

During the first quarter, the Company implemented a number of business initiatives, as outlined in Spectral’s investor update call on April 6, 2023, that are targeted to enhance and accelerate Tigris enrollment. Management is pleased to report positive progress on the following initiatives:

• Enrolled eight patients in the past seven weeks since the Company’s investor update call.

• Witnessing early indications of Tigris Investigator Meeting acting as a catalyst for enrollment, with three patients enrolled in the subsequent week.

• 61 patients enrolled to date and continuing to close in on the interim target of 90 patients, an important milestone as the Company’s strategic commercial partner, Baxter, will have the opportunity to view the data as well as provide a second milestone payment to Spectral.

• 28 patients were enrolled in the last 12 months, up from 19 patients enrolled in the same period ending May 31, 2022. Enrollment rate increased to 0.19 patients per site, per month from the previous 0.18, due to strong enrollment in April and May. Enrollment rate for sites enrolling at least one patient in the last 12 months has increased to 0.29. Management is targeting an enrollment rate of 0.25 patients per site per month for all sites.

• On track to have 25 active trial sites open by the end of September 2023, with three new sites anticipated to be open for enrollment in June.

• New CRO transition progressing on schedule, with full transition expected to be complete by the end of June.

• Crude mortality results of those enrolled in the Tigris study, thus far, continue to exceed expectations.

While the Company is witnessing initial benefits of its business initiatives, Management believes that the Company will realize the full impact of these initiatives over time. Management looks forward to reporting Tigris progress as material developments unfold.