Spectral Medical Provides Tigris Trial Update
03 Oktober 2023 - 2:00PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late-stage theranostic company advancing
therapeutic options for sepsis and septic shock, today provided an
update on the progress of its Tigris trial including patient
enrollment and new trial site additions to further accelerate
patient enrollment.
As of October 2, 2023, the Company had 74
patients enrolled in its Phase 3 Tigris clinical trial with crude
mortality data continuing to exceed expectations. To further
accelerate patient enrollment, reach the interim milestone of 90
enrolled patients and subsequently complete the Tigris trial,
Spectral is on track to add seven new vetted trial sites in the
United States around the end of November 2023. The Company had
previously communicated reaching a full complement of 25 sites by
the end of September; however, administrative delays at new sites
has resulted in a slight shift in the new site onboarding
timeline.
“We are taking decisive action to maintain and
even increase momentum in patient enrollment with a view to
enrolling our interim count of 90 patients, which is expected to
play as a major catalyst for the Company,” said Chris Seto, Chief
Executive Officer of Spectral Medical. “Based on the pace of
patient enrollment in the past number of months, and our activities
around site additions, we are optimistic on the prospect of
reaching the 90 patient interim milestone around the end of
2023.”
As a reminder, under the exclusive distribution
agreement between Spectral and Baxter International (NYSE.BAX),
following the enrollment of 90 patients, Baxter will have the
opportunity to view the crude data as well as provide a second
milestone payment to Spectral in order to affirm and maintain its
exclusive distribution rights to PMX.
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™ (“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 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.
Spectral is listed on the Toronto Stock Exchange
under the symbol EDT. For more information please visit
www.spectraldx.com.
Forward-looking statement
Information in this news release that is not
current or historical factual information may constitute
forward-looking information within the meaning of securities laws.
Implicit in this information, particularly in respect of the future
outlook of Spectral and anticipated events or results, are
assumptions based on beliefs of Spectral's senior management as
well as information currently available to it. While these
assumptions were considered reasonable by Spectral at the time of
preparation, they may prove to be incorrect. Readers are cautioned
that actual results are subject to a number of risks and
uncertainties, including the company’s ability to raise capital and
the availability of funds and resources to pursue R&D projects,
the recruitment of additional clinical trial sites, the rate of
patient enrollment, the successful and timely completion of
clinical studies, the success of Baxter’s commercialization
efforts, the ability of Spectral to take advantage of business
opportunities in the biomedical industry, the granting of necessary
approvals by regulatory authorities as well as general economic,
market and business conditions, and could differ materially from
what is currently expected.
The TSX has not reviewed and does not accept responsibility for
the adequacy or accuracy of this statement.
For further information, please contact:
Ali Mahdavi |
David Waldman/Natalya Rudman |
Blair McInnis |
Capital Markets & Investor
Relations |
US Investor Relations |
CFO |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
Spectral Medical Inc. |
416-962-3300 |
212-671-1020 |
416-626-3233 |
am@spinnakercmi.com |
edt@crescendo-ir.com |
bmcinnis@spectraldx.com |
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