Episode to be Broadcast on September 11th, 2023, at 7:30 a.m. (ET/PT) preceding World Sepsis Day on September 13th
TORONTO, Canada – August 16, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today highlighted a new episode of The Balancing Act with a segment focused on advancing therapeutic options for sepsis and endotoxic septic shock. The episode features the severe complications of endotoxic septic shock (ESS), and follows 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.
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 71 patients enrolled to date. We are pleased to partner with The Balancing Act to increase the awareness of endotoxic septic shock, by far the most aggressive form of sepsis, 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 sepsis community is doing to educate 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 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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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
Spectral Medical Inc.