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SPECTRAL Medical Spectral Announces Third Quarter Results and Provides Corporate Update Reports early patient mortality data in Tigris Trial on target with expectations TORONTO , Nov. 12 , 2021 ( 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 announced its financial results for the third quarter ended September 30 , 2021 , and provided a corporate update . - Chris Seto , CEO of Spectral , commented , " We are pleased to report progress on the clinical development of Toraymyxin ™ ( " PMX " ) , though the direct impact of covid outbreaks continue to correlate to decreased enrollment . As we entered Q3 2021 , enrollment activity ramped up significantly following our June investigator meeting – increasing approximately 40 % over a three month period as several of our clinical sites experienced a more ' normalized ' clinical trial environment . However , the rapid emergence of the delta variant at the tail end of the quarter effectively halted Tigris patient enrollment as many trial site ICUs once again refocused their efforts and resources on addressing the COVID - 19 pandemic . We view the summer enrollment rates somewhat as a proxy for the velocity of patient enrollment once the impact of COVID recedes . We continue to move forward with trial activities , including onboarding of new trial sites , and we have a high degree of confidence that the full fifteen sites will be screening and open for enrollment by the end of November 2021. Although the sample size data are limited , we are encouraged by initial patient mortality data , which is in line with our expectations . " Dr. John Kellum , Chief Medical Officer of Spectral , commented , " We remain focused on the start of our DIMI usability trial for home use of this exciting new device aimed at a $ 5.3 billion U.S. home dialysis market . We had anticipated first patient enrollment into the DIMI usability trial at the beginning of Q4 2021 , but now expect to begin the trial in Q1 2022 , as our potential clinical site trial partners address labor shortages and attrition within dialysis clinics , making it difficult to participate in the usability trial until that time . In the meantime , we have submitted an amendment for the DIMI IDE protocol with the FDA , which , if approved , would allow study patients to continue to utilize the device at home until the FDA provides clearance for in- home use . We have also refined our protocol to be minimally intrusive on the dialysis clinics staff . We believe the steps we are taking will help us achieve our target of enrolling 35 patients into the study within the shortest timeframe possible . " The Company also announced that Chris Seto , CEO of Spectral , has been appointed to the Board of Directors , increasing the number of board members to seven . Mr. Seto concluded , " In addition to my current role as CEO , I am honored to join the board of directors at this important inflection point for the Company . We remain focused on executing our clinical programs as efficiently as possible . We look forward to a number of key upcoming milestones , that we believe will drive significant shareholder value . " Program Update Tigris Trial • Number of Tigris Sites Despite a challenging clinical environment due to COVID - 19 , Spectral has had success in adding new trial sites with 12 trial sites open for enrollment and now actively screening patients , as well as another 3 clinical sites with investigator agreements in place . The Company is in the process of onboarding the remaining clinical trial sites , with a high degree of visibility that all 15 trial sites are anticipated to be screening patients by the end of November 2021 . • Tigris Enrollment Tigris currently has a total of 25 patients randomized to - date out of the 150 total to be enrolled . Although the sample size and data are limited , we are encouraged by preliminary patient mortality data , which is in line with our expectations . Dialco ⚫ DIMI Usability Trial Commencement of the DIMI IDE trial was postponed to the end of the first quarter of 2022 , due in large part to the impact of the COVID - 19 , pandemic , as the Company awaits final commitments from its trial site partners to initiate the clinical trial . On November 5 , 2021 Dialco submitted an IDE protocol amendment for the DIMI IDE Trial , which , if approved , would allow study patients to continue to utilize the device at home until the FDA provides clearance for in - home use . The IDE protocol amendment would also allow changes to patient flow procedures that are intended to simplify protocols , making the trial easier to administer for both patients and clinical staff , as well as the Company . Dialco anticipates FDA authorization of the amendment in early December 2021 . • DIMI Commercialization In order to support commercial expansion , and in anticipation to the start - up of the DIMI usability trial , Dialco is