TTOO News & Events

"We made considerable progress across the business during 2024, increasing our global installed base of T2Dx Instruments, and generating record sales for our sepsis test panels, including record U.S. sales of the T2Bacteria Panel and record international sales of the T2Resistance Panel. We entered into an exclusive U.S. commercial distribution agreement with Cardinal Health during the fourth quarter, which we expect to be a commercial growth driver, and we are training Cardinal's sales team the week of January 6, 2025," stated John Sperzel, Chairman and CEO of T2 Biosystems. "We are excited by the progress on our product pipeline in 2024, which included FDA 510(k) clearances for the expanded T2Bacteria Panel to include the detection of Acinetobacter baumannii, and the expanded claim for the T2Candida Panel to include pediatric testing. Additionally, we have three pipeline products that have received FDA Breakthrough Device designation, including the U.S. T2Resistance Panel, the T2Lyme Panel, and the Candida auris test. We believe we are well-positioned heading into 2025, and we expect to accelerate our product sales, enhance our operations, and continue to advance our new product pipeline."

T2 Biosystems 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, faster targeted therapy, and reduced length of stay. 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, rapid turnaround time, and clinical impact.

T2 Biosystems announced plans to license its proprietary technology to expand its leadership in direct-from-whole-blood detection of sepsis-causing pathogens. T2 Biosystems' proprietary technology is a key component of its FDA-cleared products, including the first and only products able to detect sepsis-causing pathogens directly from whole blood.