Spectral Medical Inc. Announces Results of Annual Meeting of Shareholders

2024-06-07

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高管变更临床3期上市批准突破性疗法

TORONTO, June 07, 2024 (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 announced the results of its Annual Meeting of shareholders (the "Shareholders") held earlier today (the "Meeting"). The Company confirms that all resolutions put forward in the Management Information Circular dated April 19, 2024 (the "Circular") 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:

NomineeVotes For (percent)Votes Withheld (percent)Jan D'Alvise99.06%0.94%Jun Hayakawa99.69%0.31%Chris Seto86.08%13.92%William Stevens99.06%0.94%Paul Walker97.86%2.14%David W. Feigal, Jr.99.59%0.41%Cristiano Franzi99.73%0.27%

Appointment of Auditors

PricewaterhouseCoopers LLP, Chartered Accountants, was re-appointed as auditor of Spectral.

Votes For: 95.01%

Votes Withheld: 4.99%

About Spectral

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 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 vs 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 https://www.youtube.com/watch?v=6RANrHHi9L8.

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. For more information, please visit www.spectraldx.com.

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

For further information, please contact:

Ali Mahdavi

Capital Markets & Investor Relations

Spinnaker Capital Markets Inc.

416-962-3300

am@spinnakercmi.com

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