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Spectral Medical Inc
Symbol EDT
Shares Issued 280,380,539
Close 2024-06-28 C$ 0.47
Market Cap C$ 131,778,853
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Spectral enrolls nine patients in Tigris trial in June

2024-07-02 13:20 ET - News Release

Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES JUNE 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.

Enrollment:

  • Robust enrollment activity continuing throughout the first half of 2024:
  • 116 patients enrolled at end of June 2024
  • Record monthly enrollment with nine patients enrolled in June
  • Thirty-five patients enrolled in 2024 so far - represents the most robust enrollment rates since the start of the Tigris study
  • With 34 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial

Trial Sites:

  • Currently 23 clinical sites
  • Recently onboarded the Thomas Jefferson University an experienced, high-quality site from the EUPHRATES trial
  • Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible

Dr. John Kellum, Chief Medical Officer of Spectral, noted, "The excitement level has never been higher. In addition to record enrollment in June for the trial as a whole, individual sites have been extremely busy. The commitment to the success of the trial is evidenced from the broad participation from sites including enrollment on nights and weekends."

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(TM) ("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(TM)), 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.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.

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. For more information, please visit www.spectraldx.com.

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