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Tenax Therapeutics cardiac surgery drug fails in phase 3 trial

Tenax Therapeutics Inc.'s phase 3 study on Levosimendan for use in cardiac surgery did not meet its primary endpoints.

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 a reduction in low cardiac output syndrome and a reduction in the post-operative use of secondary inotropes.

Tenax has a meeting scheduled with the U.S. FDA to review the preliminary trial data and discuss possibilities of bringing this treatment to patients undergoing serious cardiac surgery.