Spectral Medical Chair to Retire From the Board of Directors

2024-04-02

高管变更上市批准临床3期引进/卖出突破性疗法

Dr. Paul Walker to succeed as Chair

TORONTO, April 02, 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 that 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 Tony 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, CEO of Spectral Medical.

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 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 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 company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, 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 Chris SetoCapital Markets & Investor Relations CEOSpinnaker Capital Markets Inc. Spectral Medical Inc.416-962-3300 am@spinnakercmi.com cseto@spectraldx.com