Episode to be Broadcast on Monday, September 11th and Tuesday, September 19th, 2023 at 7:30 a.m. (ET/PT)
TORONTO, Canada – September 8, 2023 – 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 announce a new episode of The Balancing Act focused on advancing therapeutic options for sepsis and endotoxic septic shock (ESS). This compelling episode will provide insight into endotoxic septic shock, its causes, symptoms and treatment options. Additionally, the episode will capture interviews with physicians and clinical trial clinicians involved in Spectral’s pivotal TIGRIS trial which is poised to vastly improve outcomes with a targeted diagnostic test (EAA) and its lead product PMX (Toraymyxin™ PMX-20R) for treatment of patients with endotoxic septic shock.
If you are not able to catch the live episode, you can also find it on YouTube: https://www.youtube.com/user/TheBalancingAct
Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We continue to work aggressively to complete the enrollment of our Tigris Trial and currently have 72 patients enrolled to date. With an additional three study sites onboarding in the coming weeks, we could potentially see a further acceleration of enrollment activity. We are pleased to partner with The Balancing Act to increase the awareness of sepsis as well as our ongoing efforts to bring a personalized therapy to help patients suffering from endotoxic septic shock and hope to bring a new standard of care to the market.”
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 endotoxemic 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.
About The Balancing Act
The Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime®, and find all previously aired episodes on TheBalancingAct.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.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement
For further information, please contact:
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.
David Waldman/ Natalya Rudman
Crescendo Communications, LLC
Spectral Medical Inc.