Spectral Medical Provides Tigris Trial Update
74 patients enrolled
New sites to further accelerate patient enrollment
On track to onboard seven new trial sites around the end of November 2023
TORONTO, Oct. 03, 2023 (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 on the progress of its Tigris trial including patient enrollment and new trial site additions to further accelerate patient enrollment.
As of October 2, 2023, the Company had 74 patients enrolled in its Phase 3 Tigris clinical trial with crude mortality data continuing to exceed expectations. To further accelerate patient enrollment, reach the interim milestone of 90 enrolled patients and subsequently complete the Tigris trial, Spectral is on track to add seven new vetted trial sites in the United States around the end of November 2023. The Company had previously communicated reaching a full complement of 25 sites by the end of September; however, administrative delays at new sites has resulted in a slight shift in the new site onboarding timeline.
“We are taking decisive action to maintain and even increase momentum in patient enrollment with a view to enrolling our interim count of 90 patients, which is expected to play as a major catalyst for the Company,” said Chris Seto, Chief Executive Officer of Spectral Medical. “Based on the pace of patient enrollment in the past number of months, and our activities around site additions, we are optimistic on the prospect of reaching the 90 patient interim milestone around the end of 2023.”
As a reminder, under the exclusive distribution agreement between Spectral and Baxter International (NYSE.BAX), following the enrollment of 90 patients, Baxter will have the opportunity to view the crude data as well as provide a second milestone payment to Spectral in order to affirm and maintain its exclusive distribution rights to PMX.
About Spectral
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 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 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 company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, 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:
Ali Mahdavi | David Waldman/Natalya Rudman | Blair McInnis |
Capital Markets & Investor Relations | US Investor Relations | CFO |
Spinnaker Capital Markets Inc. | Crescendo Communications, LLC | Spectral Medical Inc. |
416-962-3300 | 212-671-1020 | 416-626-3233 |
