Tenax : Phase 3 LEVO-CTS Trial In Cardiac Surgery Fails To Meet Dual Endpoint.

(RTTNews) - Tenax Therapeutics Inc. (TENX) announced 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 said it has a meeting scheduled with the U.S. Food and Drug Administration 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.