Spectral Medical Announces Adoption of SAMI Device by the Largest Inpatient Dialysis Provider in South Florida

TORONTO, June 13, 2022 (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 that ARC Dialysis, the largest inpatient dialysis provider in South Florida, has selected the SAMI device for inpatient dialysis services. This latest agreement follows a clinical evaluation performed by ARC Dialysis in 2021.

ARC Dialysis is an independent dialysis provider, specializing in acute, outpatient and in-home therapies. ARC operates twelve centers, offering in-center dialysis, home and peritoneal dialysis (PD) modalities. In addition, ARC Dialysis operates through a network of health systems and hospitals, as well as skilled nursing and rehab facilities, where it delivers inpatient dialysis services across seven states.

SAMI provides ARC Dialysis with an alternative equipment option to hospital customers who are looking to outsource dialysis treatments. Fred Dumenigo, CEO of ARC Dialysis, stated, “ARC Dialysis is excited to announce our collaboration with Dialco and its SAMI CRRT System, the latest technology available in the ICUs.”

Sam Amory, President of Dialco, commented, “We are honored to have the SAMI device selected by ARC Dialysis following an extensive clinical evaluation of the technology. We believe this selection of SAMI over competing CRRT systems reflects the workflow, economic and clinical benefits of our device. Specifically, SAMI reduces the burden on staff, due to the rapid setup, user-friendly interface, safety sensors and more. Moreover, average training time for SAMI is just four hours, versus traditional CRRT machines, which can take 18-24 hours over several days. Overall, we believe we are gaining traction in the market, as illustrated by this latest agreement, and look forward to providing further updates as we accelerate our commercial rollout.”

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. 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.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.

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.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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