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Spectral Medical Inc
Symbol EDT
Shares Issued 282,050,448
Close 2024-10-03 C$ 0.58
Market Cap C$ 163,589,260
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Spectral enrolls 132 patients in Tigris trial

2024-10-03 16:24 ET - News Release

Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES SEPTEMBER TIGRIS TRIAL UPDATE

Spectral Medical Inc. has provided an update on the company's Tigris trial, a phase 3 follow-on study evaluating the use of polymyxin B hemoperfusion (PMX) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Tigris enrolment:

  • Robust enrolment continues for 2024:
    • 132 patients enrolled at end of September, 2024:
      • 51 patients enrolled in 2024 so far versus 31 patients enrolled in all of 2023;
  • With 18 patients to target enrolment, the company has entered the final push to fully enroll and finish the Tigris trial:
    • Based on the current rate of enrolment, management estimates Tigris completion around year-end 2024.

Dr. John Kellum, chief medical officer of Spectral, noted: "We continue to enjoy very strong activity at our sites. As such, we remain confident in finalizing full Tigris enrolment around year-end 2024."

About Spectral Medical Inc.

Spectral is a phase 3 company seeking U.S. Food and Drug Administration approval for its unique product for the treatment of patients with septic shock, toraymyxin. 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, 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 United States 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.

The Tigris trial is a confirmatory study of PMX in addition to standard care versus standard care alone and is designed as a 2 to 1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis.

The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials."

Spectral is listed on the Toronto Stock Exchange under the symbol EDT.

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