T2 Biosystems Praises CDC’s Actions Aimed at Optimizing U.S. Hospital Sepsis Programs
28 Agosto 2023 - 9:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today praised actions taken by the U.S. Centers for Disease
Control and Prevention (CDC) aimed at optimizing hospital sepsis
programs in the United States.
The CDC’s newly-released Hospital Sepsis Program
Core Elements is intended to help hospitals implement, monitor, and
optimize sepsis programs and improve survival rates. The program
includes seven elements: Hospital Leadership Commitment,
Accountability, Multi-Professional Expertise, Action, Tracking,
Reporting, and Education.
“Sepsis is taking too many lives. One in three
people who dies in a hospital has sepsis during that
hospitalization. Rapid diagnosis and immediate appropriate
treatment, including antibiotics, are essential to saving lives,
yet the challenges of awareness about and recognition of sepsis are
enormous,” stated Mandy Cohen, M.D., M.P.H., CDC Director in the
release announcing the Hospital Sepsis Program Core Elements.“
That’s why CDC is calling on all U.S. hospitals to have a sepsis
program and raise the bar on sepsis care by incorporating these
seven core elements.”
T2Biosystems’ products, including the T2Dx®
Instrument, the T2Bacteria® Panel, and the T2Candida® Panel, are
the first and only FDA-cleared products able to detect
sepsis-causing pathogens directly from whole blood, in 3-5 hours,
without the need to wait days for a positive blood culture. The
limitations of blood culture are well-known, including poor
sensitivity and lengthy time to result. A meta-analysis of 14
controlled studies was published in a peer-reviewed medical journal
and compared the use of T2 Biosystems’ products to blood
culture-based protocols. T2 Biosystems’ products identified
sepsis-causing pathogens 77 hours faster, allowed patients to
receive targeted antimicrobial 42 hours faster, allowed clinicians
to de-escalate from empiric therapy 7 hours faster, and reduced
length of stay on the hospital and ICU by approximately 5 days.
Data shows that empiric protocols used to
administer antimicrobials are only optimal in 30-60% of cases, and
mortality risk increases by up to 8% for each hour of delayed
targeted antimicrobial treatment. Rapid detection of sepsis causing
pathogens is essential to achieve faster targeted antimicrobial
therapy, improve antibiotic stewardship, and reduce the threat of
antimicrobial resistance (AMR).
"We applaud the CDC and Director Dr. Mandy Cohen
for taking action to address the sepsis crisis that is plaguing
U.S. hospitals and causing the death of hundreds of thousands of
Americans each year,” stated John Sperzel, Chairman and CEO at T2
Biosystems. “We cannot continue to rely on decades-old technologies
and past processes that are failing patients, payors, and
providers. We believe CDC’s leadership will serve as a catalyst to
accelerate the adoption of new products and technologies that can
enhance the standard of care, reduce cost, and improve patient
outcomes.”
Sepsis is the leading cause of death in U.S.
hospitals, causing the death of approximately 350,000 Americans
each year, including 80,000 following discharges to hospice. Sepsis
is the leading cost of U.S. hospitalization, costing the U.S.
healthcare system $62 billion annually, as well as the leading
cause of 30-day re-hospitalization in the U.S., causing 19% of
sepsis survivors to be re-hospitalized within 30 days and 40% to be
re-hospitalized within 90 days.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, is dedicated to
improving patient care and reducing the cost of care by helping
clinicians effectively treat patients faster than ever before. T2
Biosystems’ products include the T2Dx® Instrument, the T2Bacteria®
Panel, the T2Candida® Panel, the T2Resistance® Panel, and the
T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the T2Biothreat™ Panel, the T2Cauris™
Panel, and T2Lyme™ Panel, as well as next-generation products for
the detection of bacterial and fungal pathogens and associated
antimicrobial resistance markers. For more information, please
visit www.t2biosystems.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including, without limitation, statements regarding the
ability of CDC’s leadership to serve as a catalyst to accelerate
the adoption of new products and technologies that can enhance the
standard of care, reduce cost, and improve patient outcomes, as
well as statements that include the words “expect,” “may,”
“should,” “anticipate,” and similar statements of a future or
forward-looking nature. These forward-looking statements are based
on management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, (i) any inability to (a) realize anticipated benefits
from commitments, contracts or products; (b) successfully execute
strategic priorities; (c) bring products to market; (d) expand
product usage or adoption; (e) obtain customer testimonials; (f)
accurately predict growth assumptions; (g) realize anticipated
revenues; (h) incur expected levels of operating expenses; or (i)
increase the number of high-risk patients at customer facilities;
(ii) failure of early data to predict eventual outcomes; (iii)
failure to make or obtain anticipated FDA filings or clearances
within expected time frames or at all; or (iv) the factors
discussed under Item 1A. “Risk Factors” in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2021, filed
with the U.S. Securities and Exchange Commission, or SEC, on March
31, 2023, and other filings the Company makes with the SEC from
time to time, including our Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K. These and other important factors
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While the Company
may elect to update such forward-looking statements at some point
in the future, unless required by law, it disclaims any obligation
to do so, even if subsequent events cause its views to change.
Thus, no one should assume that the Company’s silence over time
means that actual events are bearing out as expressed or implied in
such forward-looking statements. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date of this press release.
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
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