Business
Spectral Medical Announces First Quarter and Provides Corporate Update
Tigris Trial Enrollment completed Topline results expected to be released in August 2025 ...
About this update from Spectral Medical Inc
[{"type":"text","content":"Spectral Medical Announces First Quarter and Provides Corporate Update\n\n\n\n\n\n Tigris Trial Enrollment completed\n \n\n\n\n Topline results expected to be released in August 2025\n \n\n\n\n Entered into an up to US$10 million Promissory Note with Vantive to Fund Spectral to PMX commercialization\n \n\n\n\n\n\n TORONTO, May 09, 2025 (GLOBE NEWSWIRE) --\n \n Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),\n \n a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the first quarter and provided a corporate update.\n \n\n The Company made significant progress throughout the first quarter of 2025, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company recently completed full enrollment of its Tigris trial, and is expected to be in a position to share the topline results in the third quarter of this year and bringing the Company closer to U.S. FDA submission and potential U.S. FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Vantive US Healthcare LLC (“Vantive”); and most recently the parties collaborated on completing the enrolments for PrisMax sub-study in February 2025.\n \n\n Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are grateful for the strong interest in the clinical development of PMX among researchers and clinicians that has helped drive us towards completing full enrollment in the Tigris trial with a total of 157 patients. On behalf of Spectral Medical, I would like to express gratitude to the patients and their families in addition to the dedicated teams at the clinical sites, as well as our clinical and regulatory staff. We remain confident in the potential of PMX, and if ultimately approved, to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock.”\n \n\n\n\n Corporate Highlights During & Subsequent to the First Quarter of 2025\n \n\n\n\n\n Tigris\n \n\n\n\n Total enrolled patients:\n \n\n 157 total patients enrolled\n \n\n 151 evaluable patients, 100 treated with PMX\n \n\n\n\n\n\n Release of topline results:\n \n\n Data ...