TORONTO, Sept. 13, 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, is pleased to support World Sepsis Day today. World Sepsis Day is an initiative by the Global Sepsis Alliance and was established in 2012. Every year, countless events are hosted on World Sepsis Day to increase the awareness of sepsis and sepsis organizations around the world. World Sepsis Day is a great opportunity to remind the public, media, national, and international healthcare authorities, healthcare providers, healthcare workers, policymakers, and governments that there is an urgent need to increase and improve education at the facility, regional, national, and international level.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “Each year, approximately 120,000 patients in the U.S. are afflicted with the most malignant form of septic shock, endotoxic septic shock (ESS). We continue to work aggressively to complete the enrollment of our Tigris Trial and currently have 72 patients enrolled to date. To support our efforts, we have partnered with The Balancing Act to increase the awareness of endotoxic septic shock, as well as our ongoing efforts to bring a personalized therapy to market. In addition, we support all the efforts that go into World Sepsis Day and the work the organization does to educate the market and people on the severity of sepsis. 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.”
Spectral Medical is at the forefront of scientific endeavors, focusing on a precision-based strategy designed to substantially enhance outcomes in ESS patients. Our approach involves a targeted diagnostic assay with an innovative therapeutic intervention, specifically engineered for the removal of endotoxins from the circulatory system. This targeted diagnostic and therapeutic (theranostic) strategy, as featured on @BalancingActTV, is currently undergoing a phase 3 clinical trial, presenting a promising avenue for patients and caregivers confronted with this complex condition.
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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.
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.
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