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SPECTRAL Medical Spectral Announces First Quarter Results and Provides Corporate Update TORONTO , May 14 , 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 first quarter ended March 31 , 2021 , and provided a corporate update . Chris Seto , CEO of Spectral , commented , " We are bullish on Spectral's prospects for 2021 , as we continue to progress both our Toraymyxin ™ ( “ PMX ” ) platform . as well as both our SAMI and DIMI devices . Although we have faced headwinds in the Tigris trial related to the COVID - 19 pandemic , we have initiated 11 trial sites and are making excellent progress towards initiating the remaining sites . Moreover , we are encouraged by the early results from the Tigris trial , as the mortality outcome data to date is in - line with expectations as far as efficacy and safety are concerned . We are working aggressively to complete the trial and look forward to reporting topline data in the first half of 2022 , a key upcoming milestone for the Company . We continue to be extremely well positioned without any competition in a US $ 1.5 billion market , while septic shock remains a leading cause of death in ICUs and a major contributor to healthcare costs . " - Mr. Seto continued , " We are also making rapid progress advancing both our SAMI and DIMI devices to capture a significant share of the $ 10 billion dialysis market by simplifying the RRT procedures and removing barriers to a wider adoption of home dialysis . As previously announced , we recently obtained our Health Canada ( HC ) license for the DIMI RRT system . We were also granted Investigational Device Exemption ( IDE ) authorization by the United States Food and Drug Administration ( FDA ) to conduct a usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment . We expect to enroll 35 patients in this trial , which is designed to evaluate the safety and efficacy of DIMI in the home setting . an underserved market that is forecast to reach $ 2.9 billion by 2025. Towards this end , we recently entered into an expanded , long - term licensing agreement with Infomed SA for the DIMI hemodialysis system , extending Dialco's exclusive rights in the United States and Canada through 2041. In terms of our SAMI device , which already has both FDA and Health Canada regulatory approvals , we are building our salesforce and commercial infrastructure to capitalize on the significant market opportunity . " " Overall , we believe we have successfully navigated through many of the challenges presented by the ongoing pandemic and remain highly encouraged by the outlook for the business . We have strengthened our senior management team , including the appointment of Dr. John Kellum as Chief Medical Officer . We believe we have built an exceptional platform with unparalleled clinical and commercial experience in both the sepsis and RRT markets , which we believe will help drive our future success . " Program Update Tigris Trial and Regulatory Program Tigris trial patient enrollment and new trial site onboarding continue to be negatively impacted by the COVID - 19 pandemic , with most trial site ICUs diverting their research resources and focus to conducting trials and treating COVID - 19 positive patients since March 2020. While some Tigris sites have remained open to enrollment throughout the pandemic , patient enrollment has been low . However , the Company's clinical team is in regular communication with trial site principal investigators and clinical staff . Based on these discussions , the Company anticipates a return to normalized recruitment activity levels , with all 11 trial sites indicating active screening status by early June . • Patient Enrollment 15 patients have been randomized to - date ( out of the 150 total patients to be enrolled in the Tigris trial ) . While current enrollment is below pre - pandemic expectations , the Company continues to be pleased by the early results from the Tigris trial . While the existing randomized patient sample size is limited , the mortality outcome data to date is inline with the Company's Euphrates post - hoc experience . • Clinical Trial Sites The Tigris trial currently has 11 sites initiated , with room to expand to 15 sites . In the Company's fiscal 2020 year end disclosure , the Company targeted initiation of all 15 sites by the end of the third quarter 2021 . • Timing Dialco The Company continues to focus on finalizing the Tigris trial within the reasonably shortest timelines . Despite the hurdles presented by the COVID - 19 pandemic , the Company continues to drive for completion of the trial in H1 2022 . ⚫ DIMI Usability Trial On February 23 , 2021 , Dialco was granted IDE authorization by the United States Food and Drug Administration FDA to conduct a usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment . The approved IDE usability trial is expected to enroll 35 patients and is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events occurring during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients . The