Spectral Medical Supports World Sepsis Day
13 September 2023 - 1:00PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late-stage theranostic company advancing
therapeutic options for sepsis and septic shock, is pleased to
support World Sepsis Day today. World Sepsis Day is an initiative
by the Global Sepsis Alliance and was established in 2012. Every
year, countless events are hosted on World Sepsis Day to increase
the awareness of sepsis and sepsis organizations around the world.
World Sepsis Day is a great opportunity to remind the public,
media, national, and international healthcare authorities,
healthcare providers, healthcare workers, policymakers, and
governments that there is an urgent need to increase and improve
education at the facility, regional, national, and international
level.
Dr. John Kellum, Chief Medical Officer of
Spectral Medical, commented, “Each year, approximately 120,000
patients in the U.S. are afflicted with the most malignant form of
septic shock, endotoxic septic shock (ESS). We continue to work
aggressively to complete the enrollment of our Tigris Trial and
currently have 72 patients enrolled to date. To support our
efforts, we have partnered with The Balancing Act to increase the
awareness of endotoxic septic shock, as well as our ongoing efforts
to bring a personalized therapy to market. In addition, we support
all the efforts that go into World Sepsis Day and the work the
organization does to educate the market and people on the severity
of sepsis. We are proud to be a part of this effort to help
patients suffering from endotoxic septic shock and hope to bring a
new standard of care to the market.”
Spectral Medical is at the forefront of
scientific endeavors, focusing on a precision-based strategy
designed to substantially enhance outcomes in ESS patients. Our
approach involves a targeted diagnostic assay with an innovative
therapeutic intervention, specifically engineered for the removal
of endotoxins from the circulatory system. This targeted diagnostic
and therapeutic (theranostic) strategy, as featured on
@BalancingActTV, is currently undergoing a phase 3 clinical trial,
presenting a promising avenue for patients and caregivers
confronted with this complex condition.
For the full story, visit https://youtu.be/6RANrHHi9L8
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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