Mr. Chris Seto reports
SPECTRAL MEDICAL INC. ANNOUNCES CLOSING OF APPROXIMATELY C$8.5 MILLION CONVERTIBLE NOTES FINANCING
Spectral Medical Inc. has confirmed the closing of previously announced offering of 9-per-cent convertible notes of the company at a price of $1,000 (U.S.) per convertible note due on May 1, 2028, for gross proceeds of approximately $8.5-million. Paradigm Capital Inc. acted as the underwriter for the offering. The net proceeds from the offering are expected to be primarily used by the company on its phase 3 registration trial (Tigris) for its PMX treatment for endotoxemic septic shock and for general corporate and working capital purposes.
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 endotoxin activity assay (EAA), the only FDA-cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients 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 United States Food and Drug Administration 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.
We seek Safe Harbor.
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