Spectral Provides Update on the Commercial Development of its SAMI Device for Continuous Renal Replacement Therapy
TORONTO, April 02, 2020 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, is pleased to provide an update on the commercialization activities at Dialco Medical Inc. (“Dialco”), a wholly-owned subsidiary of Spectral, with respect to its SAMI device for CRRT.
The commercialization of SAMI, an innovative and easy-to-use CRRT (continuous renal replacement therapy) device, is progressing as planned. The Company has added two new hospitals as SAMI customers, which are located in the mid-west United States and greater Toronto area. Dialco remains actively engaged in the path toward 510k clearance by the Food and Drug Administration (“FDA”) for its DIMI home hemodialysis device.“We believe that the onboarding of these two new customers validates the value proposition of our SAMI device in the CRRT marketplace. SAMI is a cost effective, easy-to-train and easy-to-use device, which is being embraced by our growing base of customers and getting a lot of attention,” said Dr. Gualtiero Guadagni, President at Dialco. “We are fully committed to supporting these early adopters that have tested our SAMI system and have now decided to migrate it into their clinical practice. Despite the COVID-19 environment, our team continues to focus on the deployment of SAMI through the adoption and development of virtual technologies to support the remote installation, training, and clinical usage of our products with healthcare customers.” About SpectralSpectral is a Phase III 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 has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 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. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.Forward-looking statementInformation 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.For further information, please contact: