T2 Biosystems Praises CDC’s Actions Aimed at Optimizing U.S. Hospital Sepsis Programs

The U.S. Centers for Disease Control and Prevention Releases 2023 Hospital Sepsis Program Core Elements

LEXINGTON, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) — 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 Biosystems
T2 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 Statements
This 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 Group
ir@T2Biosystems.com
415-937-5406