In September 2020, BARDA exercised the first contract option valued at $10.5 million. In August 2020, the FDA issued EUA for the T2SARS-CoV-2 Panel. The CDC estimates that sepsis causes more than 270,000 American deaths per year. 8226; Broaden Our Addressable Markets Beyond Infectious Disease. In November 2019, we received CE Mark for T2Resistance. Antimicrobial therapies may be administered to a patient prior to taking a blood sample. 8 • Slow-Growing Pathogens Can Cause False Negative Results. Each are listed in abbreviated form in the tables below. Consistent with other studies, the time savings afforded by T2Candida was significant. Below is a summary of some those reports. - Additionally, 75% of negative patients had antifungals discontinued or deescalated. 18 The clinical study consisted of two arms, a prospective arm and a seeded arm. T2Bacteria demonstrated 100% sensitivity compared to blood culture. Our particles are supplied by a sole source supplier, GE Healthcare. We also own or license over 50 pending or granted counterpart applications worldwide. However, these can be difficult to protect. Some low risk devices are exempted from this requirement. At December 31, 2020, we had an accumulated deficit of $423.0 million. There can be no assurances that we would be successful in obtaining a waiver. We cannot be certain that we will achieve or sustain profitability. If we are unable to successfully manage our growth, our business will be harmed. In addition, recent healthcare reforms have strengthened these laws. We may fail to obtain any of these licenses on commercially reasonable terms, if at all. An active trading market for our common stock may not be sustained. We continue to be subject to applicable securities rules and regulations. We could be subject to securities class action litigation.