TORONTO, Canada – July 13, 2022 – 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 Chris Seto, CEO, and Dr. John Kellum, CMO, of Spectral Medical, will be participating at the Benzinga All Access event taking place on July 15, 2022. Mr. Seto and Dr. Kellum are scheduled to present at 10:20 a.m. Eastern Time, Friday, July 15.
The event will be broadcast live and can be viewed at Benzinga All Access.
A recording of the presentation will be made available on Spectral’s website under the investor relations section at https://spectraldx.com/investors/.
Benzinga All Access is a first-of-its-kind show: part interview, part investor presentation. On All Access, Benzinga partners with companies to bring you in-depth one-on-one conversations with executives across a wide range of industries and asset classes. From emerging biotechs, to alternative real estate investment platforms, to everything in between, guests on All Access have one thing in common: they want to tell their story to investors.
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. In July 2022, the U.S. FDA granted Spectral Medical Breakthrough Device Designation for PMX.
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.
For further information, please contact:
Mr. Blair McInnis
Spectral Medical Inc.
416-626-3233
bmcinnis@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.
416-962-3300
am@spinnakercmi.com
David Waldman/ Natalya Rudman
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com