Robust recruitment activities experienced in closing weeks of September
44 patients now enrolled
TORONTO, Canada – October 4, 2022 – 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, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated 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:
- 44 patients enrolled to date out of the 150 total to be enrolled in the Tigris trial
- Three new clinical trial sites expected to be onboarded throughout October, bringing the number of total sites to 17
- Anticipate 20 total clinical trial sites by the first quarter of 2023
- Preliminary mortality outcome data to date continues to exceed expectations
“We experienced broad based recruitment activities across our Tigris study sites to close out September, with 44 patients now enrolled out of the 150 total patients to be enrolled in the trial,” commented, Chris Seto, Chief Executive Officer of Spectral Medical. “Specifically, current sites were able to recruit and enroll four patients into the Tigris trial within eight days and we expect three additional clinical trial sites to be onboarded and actively recruiting by the end of October, bringing our total sites to seventeen. Additionally, we anticipate having a total of twenty clinical trial sites onboard by the first quarter of 2023, which would significantly increase our recruiting efforts and provide the potential to enroll patients more rapidly. With data continually exceeding our expectations and no approved or cleared treatment on the market to date, we believe, if Tigris is successful, we can swiftly move towards FDA submission and bring hope to the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated mortality rate in excess of 50%.”
Dr. John Kellum, Chief Medical Officer of Spectral Medical, added, “The fall season is always a stimulus of sepsis cases in the US. Even before influenza starts to take hold, there is usually a post-summer surge of cases. We seem to be experiencing this now. Not only has enrollment increased, but screening activities across all sites were significantly higher for September compared to August. When flu season starts, this will likely intensify. Additionally, preliminary data received to date has surpassed our expectations and reinforces our prior EUPHRATES trial data, supporting our expressed confidence in the efficacy of PMX in this patient population. We remain encouraged by the progress of the Tigris trial to date and remain focused on our goal of bringing PMX to 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, 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.
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For further information, please contact:
Mr. Blair McInnis
Mr. Ali Mahdavi
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.