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SPECTRAL Medical Spectral Announces Second Quarter Results and Provides Corporate Update TORONTO , Aug. 13 , 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 second quarter ended June 30 , 2021 , and provided a corporate update . " We are pleased to report continued positive progress , both clinically and operationally , throughout the second quarter , " commented , Chris Seto , CEO of Spectral . " Specifically , our Tigris trial is getting back on track following delays due to the pandemic , with recruitment activities returning to normalized levels as well as onboarding of the remaining clinical trial sites expected to be completed during the third quarter of 2021. We have recently experienced accelerated trial activities , with our sites experiencing heightened patient screening , enrollment , and randomization and currently have a total of 20 patients randomized out of the 150 total patients to be enrolled . There is a significant unmet need for Toraymyxin ™ ( " PMX " ) with over 1.7 million new cases of sepsis each year , in the United States alone , resulting in an estimated 250,000 annual deaths . Spectral's addressable market , which is comprised of patients suffering from endotoxemic septic shock , represents an estimated 120,000 patients per year . Based on the results of the earlier EUPHRATES trial , we are very encouraged and optimistic about the Tigris trial outcome and look forward to reporting topline data in the first half of 2022. " " We continue to advance the development and commercialization of our SAMI and DIMI devices through Dialco Medical . We are progressing our DIMI usability trial , which is designed to evaluate the safety of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients . Towards this end , we have engaged CROMSOURCE , a high quality , ISO - certified international provider of outsourced clinical trial services , as our contract research organization partner for the DIMI IDE trial . Onboarding CROMSOURCE , a recognized global leader in conducting clinical trials , is an important milestone in the trial's initiation process . We now anticipate site onboarding and commencement of enrollment activities at the beginning of the fourth quarter of 2021 with completion of the study expected during the second half of 2022. DIMI's versatility addresses many of the barriers to adoption for home hemodialysis , and positions DIMI as the ideal device for multiple segments of chronic dialysis patients . As evidenced by our activities , we are committed to bringing this disruptive innovation to market , thereby empowering more patients and their care partners to transfer in - center dialysis to their homes , which we believe will significantly enhance the quality of life for these patients and reduce the financial burden for payers . Regarding our SAMI device , we continue to invest in building out our field force and commercial infrastructure to further penetrate the market , given that we have both FDA and Health Canada regulatory approvals . " " We currently have approximately $ 13 million of cash on hand after completing the most recent financing . This financing provides us adequate funding to execute on a number of key milestones , as we work to position Spectral as a leader within the fields of septic shock and renal replacement therapy , " concluded , Mr. Seto . Program Update Tigris Trial The Tigris trial is getting back on track and patient enrollment is well underway . In anticipation of COVID - 19 receding and diminished strain on trial site ICUs , Spectral conducted an investigator meeting in June 2021 , which was well attended by the principal investigators , study site staff , and the Company's clinical team . As a result , Spectral immediately ramped up its Tigris trial initiative and clinical sites have increased activities , including heightened patient screening , enrollment , and randomization . 12 trial sites are now actively screening patients and open for enrollment . Spectral is onboarding additional clinical trial sites , including the University of Michigan , which is now actively screening patients . The Company is in the process of onboarding the remaining clinical trial sites , with all 15 trial sites anticipated to be screening patients by the end of third quarter 2021. Tigris currently has a total of 20 patients randomized to - date out of the 150 total to be enrolled . Dialco ⚫ DIMI Usability Trial On June 7 , 2021 , Dialco announced engaging CROMSOURCE as its Contract Research Organization Partner for its DIMI IDE Trial . CROMSOURCE is an ISO certified international provider of outsourced clinical trial services that has been a trusted partner to pharmaceutical , medical device , and biotechnology companies for more than 20 years . • DIMI Commercialization In order to support commercial expansion , and in anticipation to the start - up of the DIMI usability trial , Dialco is expanding its field force for sales training and technical support . Dialco currently has field representatives in Ontario and Quebec , as well as Pennsylvania , Florida and Michigan , with recruitment initiatives underway for further expansion . • SAMI Commercialization SAMI continues to be launched in Canada and the U.S. with successful clinical evaluations ongoing in key hemodialysis centres , as well as expansion of the commercial sales pipeline . As hospitals are experiencing a significant shortage of CRRT machines in COVID - 19 affected ICUs , there has been increased activity with respect to