Spectral Medical Provides February Tigris Trial Update

2024-02-28

临床3期突破性疗法上市批准

93 patients enrolled February represents a second record breaking consecutive month for patient enrollment TORONTO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. Enrollment: Robust enrollment activity continues throughout 2024: 93 patients enrolled to-date Six patients enrolled in the month of February – follows the six patients enrolled in January Twelve patients enrolled in the first two months of 2024 – represents the most robust enrollment rates since the start of the Tigris study With 57 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial To support sustained enrollment, Spectral to host an in-person Investigator Meeting March 12th & 13th in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego Trial Sites: Currently 21 Tigris trial sites, with continued progress opening an additional four new, high quality clinical sites The Institute for Extracorporeal Life Support (San Antonio, TX) finalized and executed the Tigris clinical trial agreement Expect significant site onboarding activity throughout Q1/24, with final training scheduled at three of the remaining four sites About Spectral 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 endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year. The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis . The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit Forward-looking statement Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingthe company’s ability to raise capital and the availabilityoffundsandresourcestopursueR&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. Ali Mahdavi Chris Seto Capital Markets & Investor Relations CEO Spinnaker Capital Markets Inc. Spectral Medical Inc. 416-962-3300 am@spinnakercmi.com cseto@spectraldx.com