Tenax Therapeutics Spotlights Academic Publication On Levosimendan In Cardiac Surgery

MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today highlighted a recently-published meta-analysis in the Journal of Cardiac Surgery on the role of levosimendan in cardiac surgery patients which, pooling the result of 14 previous clinical studies, showed that levosimendan decreased early mortality in patients with reduced ejection fraction (5.5% for levosimendan compared to 9.1% for the control group).

“Levosimendan reduces mortality in adults with left ventricular dysfunction undergoing cardiac surgery: a systematic review and meta-analysis”

Additional endpoint analysis showed a reduction in postoperative acute renal failure, a shorter stay in the intensive care unit, and a lower incidence of low cardiac output syndrome (LCOS) for the levosimendan group in trials. All endpoint conclusions were based only upon studies which reported those respective measures.

Tenax is currently enrolling patients in its Phase 3 LEVO-CTS trial for levosimendan, a double-blind, randomized, placebo-controlled study that is evaluating the use of levosimendan administered before and during cardiac surgery to reduce the incidence of LCOS and associated morbidity and mortality. The trial is expected to enroll 760 total patients.

“We are very encouraged by the increasing number of recent publications that point toward a potential benefit for levosimendan in this critical care indication,” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “We continue to make significant progress with our enrollment pace for the LEVO-CTS study, with 50 centers currently active and 116 patients enrolled, and we look forward to seeing topline data from this trial next year.”

The article, titled “Levosimendan reduces mortality in adults with left ventricular dysfunction undergoing cardiac surgery: a systematic review and meta-analysis,” was recently accepted in the Journal of Cardiac Surgery from Lim, et al. It was first published online on May 19, 2015, and a reference link to the abstract is provided here: http://www.ncbi.nlm.nih.gov/pubmed/25989324

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market. The company owns the North American rights to develop and commercialize levosimendan, and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The company is currently enrolling a Phase 3 trial with levosimendan in that indication, and is also supporting Imperial College London’s ongoing LeoPARDS trial for levosimendan in septic shock. For more information, visit www.tenaxthera.com.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on March 17, 2015 and annual report on Form 10-K filed on July 29, 2014, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.