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Tuesday, 03/21/2017 8:37:03 AM

Tuesday, March 21, 2017 8:37:03 AM

Post# of 27254
TENX - .5576

Tenax Therapeutics Announces Year-End 2016 Financial Results and Provides Corporate Update

MORRISVILLE, N.C. --(BUSINESS WIRE)-- Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced financial results for the full year ended December 31, 2016 and provided a corporate update.

"While we were disappointed that the LEVO-CTS trial did not meet its dual or quad primary endpoints, there are positive data in the results. Levosimendan demonstrated statistically significant reductions in clinically meaningful secondary endpoints including a reduction in low cardiac output syndrome (LCOS) and reduction in postoperative use of secondary inotropes. There was also a statistically significant increase in cardiac index in the levosimendan arm. Additionally, levosimendan was found to be safe with no clinically significant increases in hypotension or cardiac arrhythmias and the clinical data showed a numerical reduction in 90-day mortality," said John Kelley , CEO of Tenax Therapeutics .

Dr. John Alexander of the Duke Clinical Research Institute presented the results of the LEVO-CTS trial on Sunday, March 19, 2017 , during a late-breaking clinical trial session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C. Dr. Alexander concluded "levosimendan is effective and safe as an inotrope to increase cardiac output in patients at risk for perioperative low cardiac output syndrome." Slides from the presentation can be found on the Tenax website at www.tenaxthera.com. The trial results were also simultaneously published in The New England Journal of Medicine .

"Based on these positive findings, we continue to evaluate cardiac surgery and other indications that may benefit from levosimendan," said John Kelley , CEO of Tenax Therapeutics . "We have initiated discussions with the U.S. Food and Drug Administration ( FDA ) regarding the approval of levosimendan to treat Acute Decompensated Heart Failure (ADHF). Levosimendan is approved and on the market in Europe and South America for ADHF, where it has been used to treat over one million patients. We have a pre-NDA meeting scheduled with FDA to discuss a New Drug Application (NDA) for this indication in the U.S. based on existing data in ADHF, along with the positive data generated in the secondary endpoints in the LEVO-CTS trial. We are also planning to begin the process of filing an application for approval to Health Canada ," continued Mr. Kelley.

While the company is working on its regulatory options for levosimendan, it will explore additional strategic options to broaden its product lines. To this end, the company will engage an investment bank to assist in these efforts.




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