Spectral Medical Provides Update Following In-Person FDA 100-Day Meeting for PMX PMA

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Postmedia has not reviewed the content. by GlobeNewswire Spectral Medical Provides Update Following In-Person FDA 100-Day Meeting for PMX PMAAuthor of the article:Last updated 6 minutes ago • Company gains further clarity on the additional information required to advance its PMA reviewTHIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an Account• FDA did not request an additional clinical trial following its 100-day review of the PMA application• Company does not currently expect a material change to its overall regulatory timelineTORONTO, Sept. 11, 2026 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update following its in-person 100-Day Meeting with the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Premarket Approval (“PMA”) application for Toraymyxin™ (“PMX”).As part of its substantive review of the PMA, FDA provided Spectral with a deficiency letter several days prior to the Company’s scheduled in-person 100-Day Meeting. Deficiency letters are commonly issued as part of the 100-day PMA review process and are used by FDA to identify additional information necessary to complete its review of an application. The letter identified a number of items requiring additional information, analyses, testing and clarification and provided the Company with the opportunity to focus the 100-Day Meeting discussion on the items identified by FDA.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againThe Company considered the meeting constructive. Based on the Company’s understanding of the discussion, Spectral has further clarity regarding the additional analyses, testing and information required to address the outstanding items and advance the PMA review. FDA did not request an additional clinical trial as part of the Company’s response to the deficiency letter. FDA’s official minutes of the meeting are the definitive record of the discussion and have not yet been issued.“We were pleased with the constructive dialogue with FDA during the in-person 100-Day Meeting,” said Chris Seto, Chief Executive Officer of Spectral Medical. “Receiving the deficiency letter in advance of the meeting allowed us to have a focused discussion with FDA regarding the outstanding items. We came away with a clearer understanding of the remaining work required to advance the review of our PMA and are actively progressing the additional analyses, testing and other activities discussed with FDA.”Spectral is incorporating FDA’s feedback into its ongoing regulatory activities and is finalizing the associated work plan and timing. Based on its current assessment, the Company does not currently expect the additional activities to result in a material change to its overall regulatory timeline. Spectral will provide further updates as appropriate.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 FDA-cleared Endotoxin Activity Assay (EAA™), the only FDA-cleared test for endotoxin in blood.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide 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. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.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, the Company’s ability to satisfactorily address the items identified in FDA’s deficiency letter and the timing thereof, 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:Ali Mahdavi Chris SetoCapital Markets & Investor Relations CEOSpinnaker Capital Markets Inc. Spectral Medical Inc.416-962-3300 am@spinnakercmi.com cseto@spectraldx.comNotice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.