Spectral Medical Announces Major Milestone by Reaching Its Interim Enrollment Target of 90 Patients
15 Febbraio 2024 - 1:41PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late-stage theranostic company advancing
therapeutic options for sepsis and septic shock, today announced a
major milestone by reaching its Interim Enrollment target of
patient 90 in its TIGRIS trial.
Under the terms of the Company’s Exclusive
Distribution Agreement with Baxter International (“Baxter”)
(NYSE:BAX), at Interim Enrollment, Baxter has the option
to make a second milestone payment to Spectral to maintain its PMX
exclusive distribution rights. As such, Spectral has formally
notified Baxter of reaching its Interim Enrollment target of 90
patients.
“Enrolling patient 90 represents a major
milestone in many ways for Spectral as we continue to see
acceleration across our Tigris trial sites and building confidence
and momentum towards completing the trial,” said Chris Seto, CEO of
Spectral Medical. “We remain confident in the outcome of Tigris and
our potential for FDA approval, and look forward to our continued
partnership with Baxter to commercialize PMX and bring a new
standard of care across ICUs in the United States.”
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.
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.
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 |
|
Chris Seto |
Capital Markets & Investor
Relations |
|
CEO |
Spinnaker Capital Markets
Inc. |
|
Spectral Medical Inc. |
416-962-3300 |
|
|
am@spinnakercmi.com |
|
cseto@spectraldx.com |
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