Provides positive case study on patient enrolled at University of Michigan
14 clinical sites actively enrolling patients with 40 patients now randomized
TORONTO, July 20, 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"), today provided a clinical trial update on Tigris, a follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating the use of Polymyxin B Hemoperfusion ("PMX") in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.
Key Tigris Trial Updates:
Dr. John Kellum, Chief Medical Officer of Spectral, stated, "I am pleased to report our trial site at the University of Michigan has randomized their first patient. The clinical staff at U of M witnessed immediate improvement in the patient's status following administration of PMX and the patient was able to transfer out of the intensive care unit (ICU) sooner than expected. We believe this positive patient outcome, and the fact that data thus far is exceeding expectations, reinforces our prior EUPHRATES trial data and our overall confidence in the efficacy of PMX in this patient population."
Kyle Gunnerson, MD, FCCM, Professor and Emergency Medicine Director at the Emergency Critical Care Center within the University of Michigan, further noted, "My team and I were very encouraged with the effectiveness of PMX in our first randomized patient within the Tigris trial. We saw rapid improvement and recovery in the patient following administration of PMX and, importantly, the patient was transferred out of the ICU sooner than we anticipated with full discharge from the hospital in under two weeks from admission. With no FDA approved sepsis solution on the market, PMX has the potential to become an effective solution for sepsis and vital for clinical care use around the world. Following the successful treatment of our first randomized patient, my clinical team and I look forward to enrolling more patients into this important study."
"We are making significant progress with our Tigris confirmatory trial and are very encouraged by the data thus far," commented, Chris Seto, Chief Executive Officer of Spectral Medical. "PMX targets a large unmet medical need that is currently estimated at $1.6 billion in the U.S. alone. With no approved or cleared treatments on the market, we believe, if Tigris is successful, we can swiftly move towards FDA submission, which follows our recent Breakthrough Device designation granted by the FDA. With continued progression of the Tigris trial, our Breakthrough Device designation, as well as our executed commercial partnership with Baxter, we remain laser focused on our goal of bringing PMX to market. Most importantly, we believe PMX will provide new hope for the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated 50% mortality rate."
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxintm ("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 (EAAtm), 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 severe sepsis and septic shock in North America each year.
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|
|[email protected]||[email protected]||[email protected]|
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