Tenax Therapeutics, Inc. announced top-line results from its Phase 3 LEVO-CTS trial. The study did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days. However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes. Patient visits for data on death through day 90 have not yet been completed. The company has a meeting scheduled with the U.S. Food and Drug Administration (FDA) to review the preliminary trial data and discuss a path forward to bring this potentially lifesaving treatment to the benefit of patients undergoing serious cardiac surgery.