23:49:57 EDT Fri 17 May 2024
Enter Symbol
or Name
USA
CA



Spectral Medical Inc
Symbol EDT
Shares Issued 278,547,804
Close 2023-05-29 C$ 0.295
Market Cap C$ 82,171,602
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Spectral Medical enrolls 8 patients in Tigris trial

2023-05-30 14:19 ET - News Release

Mr. Ali Mahdavi reports

SPECTRAL MEDICAL PROVIDES UPDATE ON 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 enrollment. Management is pleased to report positive progress on the following initiatives:

Enrolled eight patients in the past seven weeks since the Company's investor update call.

Witnessing early indications of Tigris Investigator Meeting acting as a catalyst for enrollment, with three patients enrolled in the subsequent week.

61 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.

28 patients were enrolled in the last 12 months, up from 19 patients enrolled in the same period ending May 31, 2022. Enrollment rate increased to 0.19 patients per site, per month from the previous 0.18, due to strong enrollment in April and May. Enrollment rate for sites enrolling at least one patient in the last 12 months has increased to 0.29. Management is targeting an enrollment rate of 0.25 patients per site per month for all sites.

On track to have 25 active trial sites open by the end of September 2023, with three new sites anticipated to be open for enrollment in June.

New CRO transition progressing on schedule, with full transition expected to be complete by the end of June.

Crude mortality results of those enrolled in the Tigris study, thus far, continue to exceed expectations.

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

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 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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