Spectral Medical Announces Publication of Tigris Trial Methods Paper and Simulation of Results

Tomlinson et al. Bayesian methods: a potential path forward for sepsis trials. Critical Care (2023) 27:432

TORONTO, Nov. 14, 2023 (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 publication of its Tigris trial methods paper in Critical Care, which discusses the use of Bayesian methods in clinical trial design. Simulation studies incorporating historical data from a 179-patient subgroup of Spectral’s EUPHRATES trial combined with data from the ongoing Tigris trial demonstrated an increase in power across a range of observed hypothetical results.

Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We are pleased to see the publication of this paper, in a major scientific journal. The analysis clearly indicates that our trial strategy is highly likely to succeed and not only will this support our FDA approval for PMX, but will also have a major impact on how trials in the ICU are conducted in the future. The simulations involving over 2,000 potential trial results show that using the planned 75% weight on the prior EUPHRATES data, an observed absolute risk reduction for mortality of 7% in Tigris is at approximately the 95% probability threshold for declaring PMX effective. Current results from Tigris are far in excess of this threshold.”

Chris Seto, Chief Executive Officer of Spectral commented, “We are also pleased to see all of our study site investigators participating as authors on the study as we continue to work aggressively to complete the enrollment of our Tigris Trial. We are proud to be a part of this effort to help patients suffering from endotoxic septic shock and hope to bring a new standard of care to the market.”

The Tigris Trial methods paper “Bayesian methods: a potential path forward for sepsis trials” can be accessed at: https://doi.org/10.1186/s13054-023-04717-x

About Critical Care

Critical Care is a high-quality, peer-reviewed, international clinical medical journal. Critical Care aims to improve the care of critically ill patients by acquiring, discussing, distributing, and promoting evidence-based information relevant to intensivists. Critical Care aims to provide a comprehensive overview of the intensive care field.

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.

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.

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