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Spectral Medical Inc
Symbol EDT
Shares Issued 278,644,428
Close 2024-04-01 C$ 0.46
Market Cap C$ 128,176,437
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Spectral Medical's Bihl retires as chairman

2024-04-02 12:35 ET - News Release

Mr. Chris Seto reports

SPECTRAL MEDICAL CHAIR TO RETIRE FROM THE BOARD OF DIRECTORS

Spectral Medical Inc.'s Anthony (Tony) Bihl III, Spectral's chairman, will be retiring from the board at Spectral's upcoming shareholder meeting in June, 2024.

Mr. Bihl has been a director of the company for 16 years and was appointed to the role of chairman in 2010. Mr. Bihl will step down as chair effective April 2, 2024, but will remain a director until his retirement from the board in June. Dr. Paul Walker will immediately succeed Mr. Bihl as chair.

"It has been my pleasure to serve Spectral for 16 years, including the last 14 years as chairman. Over that time, I am very proud of the clinical and regulatory progress of PMX, and the development of our commercialization pathway. I am confident that the company is today in the strongest position it has ever been, led by an exceptional executive team and a strong board who are successfully implementing a clear strategy," said Mr. Bihl.

"On my behalf and that of the entire board, we want to express our sincere appreciation for Tony's significant contributions and dedicated service during his tenure as chairman. What we accomplished together has been truly remarkable. His stewardship and counsel over the past 16 years on the board has ensured the continuity and development of our vision, which is to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock. I have been fortunate to work with Tony for the last three years and I wish him well for the future," said Chris Seto, chief executive officer of Spectral Medical.

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 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 two-to-one 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."

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