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 the sale of four T2Dx® Instruments to its European (EU) distributor that represents multiple EU counties, demonstrating commercial expansion and increased international market penetration.

The multiple instrument sale demonstrates commercial expansion to enable increased utilization of the T2Bacteria® Panel, the T2Candida® Panel, and the T2Resistance® Panel. The target hospitals for the new instruments include:

• Selling a second T2Dx Instrument to a major reference hospital to expand “same store” sales;
• Selling the first T2Dx Instrument to a hospital in a country for initial market penetration; and
• Selling two T2Dx Instruments to hospitals in countries that already utilize T2 Biosystems’ products.

“Our international distributors continue to expand the global footprint of the T2Dx Instruments and make direct-from-blood diagnostic tests available to new sepsis patients,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The availability of the T2Resistance Panel in international markets strengthens the value proposition of our T2Dx platform and we believe the clinical experience using direct-from-blood detection of antibiotic resistance genes in these markets is an important precursor to our U.S. launch of the T2Resistance Panel. We previously received Breakthrough Device designation from the FDA for the T2Resistance Panel and plan to submit a FDA 510(k) premarket notification next quarter.”

The T2Resistance Panel, which runs on the FDA-cleared T2Dx® Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens (KPC, OXA-48, CTX-M-14/15, AmpC (CMY/DHA), NDM/IMP/VIM, mecA/C, vanA/B) in 3-5 hours, without the need to wait for a positive blood culture. The T2Resistance Panel is commercially available in Europe under a CE-mark and was granted “Breakthrough Device” designation from the FDA, which provides for a prioritized FDA review process. 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 vs. 58.3 hours), and clinical impact (i.e., clinical interventions in 41% of patients in the study; 24 of 59 patients).

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 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 sale of additional instruments will result in increased sepsis test revenue and the customer adoption of the Company’s direct-from-whole-blood technology will continue to grow and the likelihood that the international clinical experience with direct-from-blood detection of antibiotic resistance genes will be an important precursor to the potential launch of the T2Resistance Test in the U.S. market; 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