Spectral Medical Announces Major Milestone by Reaching Its Interim Enrollment Target of 90 Patients

2024-02-15

临床3期上市批准引进/卖出突破性疗法

TORONTO, Feb. 15, 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 announced a major milestone by reaching its Interim Enrollment target of patient 90 in its TIGRIS trial. Under the terms of the Company’s Exclusive Distribution Agreement with Baxter International (“Baxter”) (NYSE:BAX), at Interim Enrollment, Baxter has the option to make a second milestone payment to Spectral to maintain its PMX exclusive distribution rights. As such, Spectral has formally notified Baxter of reaching its Interim Enrollment target of 90 patients. “Enrolling patient 90 represents a major milestone in many ways for Spectral as we continue to see acceleration across our Tigris trial sites and building confidence and momentum towards completing the trial,” said Chris Seto, CEO of Spectral Medical. “We remain confident in the outcome of Tigris and our potential for FDA approval, and look forward to our continued partnership with Baxter to commercialize PMX and bring a new standard of care across ICUs in the United States.” 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. For further information, please contact: 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