TORONTO, Canada – November 30, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT) and its wholly-owned subsidiary Dialco Medical Inc. (“Dialco”), today announced that it will host a conference call at 2:00 PM EST on Thursday, December 2, 2021, to provide a clinical update and discuss the latest business developments.
The conference call will be available via telephone by dialing toll free 877-407-0789 for U.S. callers or for international callers +1 201-689-8562. A webcast of the call may be accessed at https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72 or on the Company’s Investor Events section of the website here. The conference call will be led by Chris Seto, Chief Executive Officer, Dr. John A. Kellum, Chief Medical Officer, and Debra M. Foster, Vice President, Clinical Development of Spectral Medical Inc.
Investors and other interested parties are invited to submit questions to management prior to the call’s start via email to firstname.lastname@example.org.
A webcast will also be archived on the Company’s Investor Events section and a telephone replay of the call will be available at 5:00 PM EST on December 2, 2021, through December 9, 2021, and can be accessed by dialing 844-512-2921 for U.S. callers or +1 412-317-6671 for international callers and entering replay pin number: 13725451.
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 has been 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.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
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.
Spectral Medical Inc.
416-626-3233 ext. 2004
David Waldman/ Natalya Rudman
Crescendo Communications, LLC