03:31:11 EDT Sat 18 May 2024
Enter Symbol
or Name
USA
CA



Spectral Medical Inc
Symbol EDT
Shares Issued 278,547,804
Close 2023-06-19 C$ 0.265
Market Cap C$ 73,815,168
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Spectral enrolls 11 patients in Tigris trial in Q2 2023

2023-06-20 11:31 ET - News Release

Mr. Blair McInnis reports

SPECTRAL MEDICAL PROVIDES UPDATE ON CONTINUED FAVORABLE TIGRIS CLINICAL TRIAL ENROLLMENT

Spectral Medical Inc. has provided an enrolment update on Tigris, the company's follow-on study designed to build on knowledge gained from the earlier Euphrates trial, which evaluated the use of polymyxin B hemoperfusion (PMX) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

During the first quarter, the company implemented a number of business initiatives, as outlined in Spectral's investor update call on April 6, 2023, that are targeted to enhance and accelerate Tigris enrolment. Management is pleased to report positive progress on the following initiatives:

  • 11 patients enrolled in the Tigris trial during the second quarter, subsequent to the company's investor update call;
    • Six of the 11 patients enrolled since the Tigris investigator meeting, held on May 17 to 18, 2023;
  • 64 patients enrolled to date and continuing to close in on the interim target of 90 patients, an important milestone as the company's strategic commercial partner, Baxter, will have the opportunity to view the data as well as provide a second milestone payment to Spectral;
    • The enrolment rate experienced over the past 10 weeks maintains the target timeline of 90 patients enrolled around the end of 2023;
  • On track to have 25 active trial sites open by the end of September, 2023, with three new sites anticipated to be open for enrolment in June, 2023;
  • New chief revenue officer transition progressing on schedule, with full transition expected to be complete by the end of June;
  • Crude 28-day mortality results, thus far, continue to exceed efficacy targets.

While the company is witnessing initial benefits of its business initiatives, management believes that the company will realize the full impact of these initiatives over time. Management looks forward to reporting Tigris progress as material developments unfold.

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). 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 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 endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.

We seek Safe Harbor.

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