Spectral Announces FDA Approval to Add Up to 10 Additional Tigris Clinical Trial Sites
TORONTO, Aug. 18, 2022 (GLOBE NEWSWIRE) -- 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 following a review of Spectral’s supplemental information to its Investigational Device Exemption (IDE) application, the United States Food and Drug Administration (FDA) has approved the addition of up to ten new clinical trial sites to the Company’s pivotal Tigris trial. This approval would bring the total potential trial sites to 25 U.S. institutions. The FDA determined that the Company provided sufficient data to support expansion of its human clinical study and that there are no subject protection concerns that preclude expansion of the investigation.
Chris Seto, Chief Executive Officer of Spectral, commented, “We are pleased to receive FDA approval to increase our Tigris clinical trial sites, which should support more rapid enrollment. We believe this approval is further validation of our progress and builds upon PMX’s recent Breakthrough Device designation by the FDA, as well as our ongoing trial results, which continue to exceed expectations.”
Dr. John Kellum, Chief Medical Officer of Spectral, stated, “Although the pandemic has made sepsis trials more challenging, we look forward to adding additional sites, which we expect will provide significantly more opportunities for enrollment. Our goal is to add at least four additional clinical trial sites by the end of October 2022. We believe having these additional sites active before flu season would be beneficial, given the prevalence of endotoxemic septic shock in these patients. In fact, Australia, often seen as a precursor to the U.S., is experiencing one of its worst flu seasons this year.”
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. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with 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 wereconsidered 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 offunds 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.