TORONTO - 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), 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.
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 300,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year. Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-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 management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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.
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SPECTRAL MEDICAL INC. 
