Video replay of sponsored symposium explaining endotoxemic septic shock and the case for hemoperfusion therapy
TORONTO, July 14, 2022 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (“Dialco”), has posted on its website a video replay from the 40th Vicenza Course on Acute Kidney Injury and Continuous Renal Replacement Therapy which featured Dr. John Kellum, Spectral Medical’s CMO.
“The symposium discussed endotoxemia and why we should care about endotoxemic septic shock which presents in about 50% of patients with septic shock, impacting approximately 120,000-150,000 patients in the U.S. per year,” stated Dr. Kellum. “Endotoxemic septic shock is a more severe form of septic shock. We believe that the combined treatment using our bio assay (EAA) which can detect endotoxin levels in the bloodstream and our PMX device (Polymyxin B Hemoperfusion) which can absorb or remove these endotoxins from the bloodstream can dramatically improve patients mortality benefit. PMX has been used effectively and safely in many countries, specifically Japan for more than 30 years and in Italy for more than 20 years. The Company continues in its efforts to complete the Tigris Trial, seeking U.S. FDA approval of its PMX device.”
Professor Massimo Girardis from the University of Modena in Italy, also spoke at the symposium and discussed his experience with PMX Hemoperfusion.
The Company will be posting additional video replays from the event covering the role of biomarkers and availability of new tools in classification and treatment of acute kidney injury and a discussion on the rationale for polymyxin B hemoperfusion and other therapies in treating sepsis.
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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year. In July 2022, the U.S. FDA granted Spectral Medical Breakthrough Device Designation for PMX.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
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 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.
|Mr. Blair McInnis||Mr. Ali Mahdavi||David Waldman/Natalya Rudman|
|CFO||Capital Markets & Investor Relations||US Investor Relations|
|Spectral Medical Inc.||Spinnaker Capital Markets Inc.||Crescendo Communications, LLC|
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