TTOO T2 Biosystems Inc

T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has surpassed the shipment of 250,000 sepsis tests, marking a significant milestone that underscores the growing customer adoption of the Company’s direct-from-whole-blood technology.

A meta-analysis of 14 controlled studies, published in a peer-reviewed medical journal, compared T2 Biosystems’ sepsis tests to blood culture-based diagnostics, and showed that T2 Biosystems’ products provided: faster time to detection (e.g., species identification 77 hours faster), faster targeted therapy (e.g., patients testing positive with T2 Biosystems receiving targeted antimicrobial therapy 42 hours faster), and reduced length of stay (e.g., 5.0 fewer days in the ICU and 4.8 fewer days in the hospital). In March 2024, the Company announced the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy (i.e., 94.7% sensitivity, 97.4% specificity), rapid turnaround time (i.e., results available in 4.4 hours versus 58.3 hours), and clinical impact (i.e., clinical interventions in 41% of patients in the study; 24 of 59 patients).

“We are honored that hospitals have chosen to use our direct-from-blood diagnostic tests to care for hundreds of thousands of patients with bloodstream infections or sepsis, enabling clinicians to achieve faster targeted antimicrobial treatment,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Alternative diagnostics that that are used to identify sepsis-causing pathogens and antibiotic resistance first require a positive blood culture, which can take days, and it is well-understood that the risk of death increases by up to eight percent per hour of delayed targeted antimicrobial treatment.”

T2 Biosystems has developed and commercialized the T2Dx® Instrument, the T2Bacteria® Panel, and the T2Candida® Panel, the only FDA-cleared products able to detect bacterial and fungal sepsis-causing pathogens directly from whole blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The T2Bacteria Panel detects six bacterial species that account for nearly 75% of all bacterial bloodstream infections in the U.S, and the T2Candida Panel detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S. The Company is also marketing and selling the CE-marked T2Resistance® Panel in select European markets, which detects thirteen antibiotic resistance genes directly from whole blood, in just 3-5 hours, and which has also received FDA Breakthrough Device designation.

The Company’s competitors that market FDA-cleared products to detect sepsis-causing pathogens and antibiotic resistance are currently dependent on positive blood culture results. When these firms market that their products provide species identification results in 1-3 hours, or antibiotic susceptibility results in 7 hours, it is important to understand that these turnaround times are only after waiting 1-5 days for a positive blood culture. Further, if blood culture produces false negative results due to poor sensitivity, these blood culture-dependent diagnostics provide little to no value.

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 are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. 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 likelihood that the customer adoption of the Company’s direct-from-whole-blood technology will continue to grow and hospitals will continue to choose the Company’s direct-from-blood diagnostic tests to care for their patients with bloodstream infections or sepsis; and all other 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, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, 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