An anonymous director reports
SPECTRAL MEDICAL INC. FILES BASE SHELF PROSPECTUS AND REVISED AIF
Spectral Medical Inc. has filed a final short-form base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada, except Quebec, on Sept. 26, 2025.
The base shelf prospectus allows Spectral to qualify the distribution by way of a prospectus of up to $100-million of common shares, debt securities, subscription receipts, warrants and units, or any combination thereof, from time to time, during the 25-month period from the effective date. The specific terms of any offering under the base shelf prospectus will be established in a prospectus supplement, which will be filed with the applicable securities regulators in connection with any such offering.
Spectral has also revised its annual information form (AIF) for the year ended Dec. 31, 2024, as requested by the Ontario Securities Commission, to disclose a director's prior role as an executive officer and director of a corporation that was involved in bankruptcy proceedings and, further, to incorporate updates regarding the release of top-line results from the Tigris clinical trial.
A copy of the base shelf prospectus and revised AIF can be found under the company's profile on SEDAR+.
About Spectral Medical Inc.
Spectral is a phase 3 company seeking U.S. Food and Drug Administration approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the company's FDA-cleared endotoxin activity assay (EAA), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively, with over 360,000 units sold worldwide to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the United States for PMX and, in November, 2010, signed an exclusive distribution agreement for this product in Canada. In July, 2022, the U.S. FDA granted breakthrough device designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX in addition to standard care versus standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT.
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