• Operating the SAMI viewed as both simple and safe by the nurses
  • Successful remote deployment of SAMI with only 3 hours of virtual training

Toronto, Ontario |  November 11, 2020 – 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, today announced that a paper reporting on the deployment and use of its SAMI unit during the COVID-19 pandemic has been published in the Journal of Blood Purification. SAMI is a renal replacement therapy (RRT) machine manufactured and commercialized by Spectral’s wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”).

The paper, entitled: ”Deployment of a new CRRT/PIRRT device during the COVID-19 pandemic emergency: organizational challenges and implementation results” reports the clinicians’ experience in implementing the use of SAMI at the University of Michigan Medical Center (“UMMC”). The paper describes the first month of using SAMI as part of UMMC’s PIRRT (Prolonged Intermittent Renal Replacement Therapy) program throughout April 2020. The installation and training were successfully managed remotely with SAMI utilized to treat 23 patients in the first 4 weeks.

The paper goes on to state, “The results from the nurse questionnaire, as well as the successful deployment of the SAMI in our institution during the pandemic with only 3-hour virtual training support that operating the SAMI is simple and safe. The setup of the SAMI has been refined to be as simple as possible, and the interactions that normally cause issues (connecting the bloodline to the various safety sensors and pumps) have been refined to almost a single gesture of inserting the disposable cassette into the machine. This approach together with a comprehensive self-testing procedure allows the unit to eliminate as many potential user errors as reasonably possible.” The full text of the paper is available at https://www.karger.com/Article/Abstract/511726

“Dialco is committed to providing our customers with innovative, reliable and simple-to-operate dialysis systems. We believe that our SAMI and DIMI machines meet these goals, and UMMC’s experience and publication is a strong validation of our devices’ easy to learn, manage and use technology,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “I am proud of the Dialco team.  Despite COVID-19 abruptly changing our work flow and customer access, we were able to adapt and deliver virtual training and technical support up to the very highest quality standards.”

About Spectral and Dialco

Spectral 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 is 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 in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.  “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.

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 or forward looking statements 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 including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.

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

For further information, please contact:

Dr. Paul Walker

President & CEO
Spectral Medical Inc.
416-626-3233 ext. 2100

Chris Seto

Spectral Medical Inc.
416-626-3233 ext. 2004

Ali Mahdavi

Capital Markets & Investor Relations