An anonymous director reports
SPECTRAL MEDICAL INC. ANNOUNCES RESULTS OF ANNUAL MEETING OF SHAREHOLDERS
Spectral Medical Inc. has released the results of its annual meeting of shareholders held earlier today. The company confirms that all resolutions put forward in the management information circular dated April 19, 2024, to its shareholders were approved.
Results of the matters voted on at the meeting are set out below.
Election of directors
Spectral's seven director nominees were elected, as shown in the associated table.
Appointment of auditor
PricewaterhouseCoopers LLP, chartered accountants, was reappointed as auditor of Spectral.
Votes for: 95.01 per cent
Votes withheld: 4.99 per cent
About Spectral
Medical Inc.
Spectral is a phase 3 company seeking United States FDA (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 U.S. 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 endotoxemic 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."
We seek Safe Harbor.
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