Spectral Medical Provides November Tigris Trial Update

• 136 patients enrolled

• Company to host Tigris Trial Update Call December 16, 2024

TORONTO, Dec. 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 provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Tigris Enrollment:

• 136 patients enrolled at end of November 2024
• Experienced significantly lower than anticipated patient enrollment in October and November due to the impact of Hurricane Helene on the medical supply chain.
  • The disruption in production of critical intravenous fluids persists. This has led to a rationing of saline, and 5L are required to prepare PMX for each treatment.
  • For more information on Hurricane Helene’s impact on the supply of critical intravenous fluids, see the following link: Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra | HHS.gov

• The Company continues to focus on finalizing the Tigris trial within the reasonably shortest timelines. While the medical supply chain issues have negatively impacted enrollment since October, management believes these supply disruptions to be short term in nature. As such, the Company is projecting full enrollment closer to the end of the first quarter of 2025.
  

Dr. John Kellum, Chief Medical Officer of Spectral, stated, “Despite the continued saline shortage impacting patient enrollment, our Tigris sites remain engaged and enthusiastic in driving towards finalizing enrollment, as we continue to see strong performance across trial sites for screening.”

Spectral Medical Tigris Trial and Corporate Update Call

Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.

CONFERENCE CALL DETAILS:

Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event. *Available 15 minutes prior to scheduled start time.

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

Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingthe company’s ability to raise capital and the availabilityoffundsandresourcestopursueR&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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