TORONTO, CANADA — March 4, 2021 – 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”), announces that it has retained Crescendo Communications, LLC (“Crescendo”) as its investor relations firm to help broaden awareness of the Company in the US financial markets.
David Waldman, President and CEO of Crescendo, commented, “We are honored to work with Spectral and look forward to supporting them in their mission of combatting the devastating impacts of sepsis, a leading cause of death in ICUs across the US. Spectral’s Toraymyxin™ PMX endotoxin removal cartridge, combined with its EAA™ diagnostic, address a dramatically underserved $1.5 billion market opportunity with no competing FDA approved solutions. Additionally, we believe there is a significant market opportunity within the Dialco business, with two first-in-class hemodialysis machines, positioned to capture significant market share within the $5.3 billion acute and home dialysis markets. We look forward to helping increase awareness within the US investment community, as Spectral advances towards a number of key milestones.”
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., 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.
For further information, please contact:
Dr. Paul Walker
Spectral Medical Inc.
416-626-3233 ext. 2100
Spectral Medical Inc.
416-626-3233 ext. 2004
David Waldman/ Natalya Rudman
Crescendo Communications, LLC