Mr. Chris Seto reports
SPECTRAL MEDICAL INC. ANNOUNCES CLOSING OF ADDITIONAL US$1 MILLION CONVERTIBLE NOTES
Spectral Medical Inc. has closed an additional non-brokered offering of $1-million (U.S.) 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.
The notes were sold to one of the company's largest shareholders pursuant to the exercise of their anti-dilution pre-emptive rights relating to the closing of the offering of the approximately $8.5-million offering of notes that was completed on May 30, 2024.
"We are pleased to have one of our largest shareholders exercise their participation rights and invest more in the company at such an exciting phase in our business," said Chris Seto, chief executive officer of Spectral. "The combination of a strong balance sheet and the current pace of patient enrolment has us well positioned as we close in on completing the Tigris trial and FDA [U.S. Food and Drug Administration] submission."
The net proceeds from the offering are expected to be primarily used by the company on its phase III registration trial (Tigris) for its PMX treatment for endotoxic septic shock and for general corporate and working capital purposes.
About
Spectral
Medical
Inc.
Spectral is a phase 3 company seeking U.S. FDA 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 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.
The trial methods are detailed in "Bayesian
methods:
a potential
path
forward
for
sepsis
trials."
Spectral is listed on the Toronto Stock Exchange under the symbol EDT.
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