Tenax Therapeutics Announces Study Design for Phase 2 Trial of Levosimendan in PH-HFpEF Patients

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, today announced the registration of their Phase 2 clinical trial in the use of levosimendan for treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) on ClinicalTrials.gov.

The Phase 2 PH-HFpEF study is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that chronic, intermittent doses of levosimendan will significantly improve hemodynamic measures of exercise performance in patients suffering from Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction. PH-HFpEF patients will be enrolled at a targeted 20-25 sites, in an open-label lead-in phase of the study. Subjects who have responded positively to the first hospital-administered dose of levosimendan will be randomized in the study and receive levosimendan or placebo for four additional weekly treatments. The study is expected to be initiated in the third quarter.

"We are very pleased to begin this new Phase 2 study, which has been designed in collaboration with - leading pulmonary hypertension and HFpEF experts to efficiently evaluate the effectiveness of levosimendan in this patient population,” said Michael Jebsen, Interim CEO of Tenax. "The estimated prevalence of PH-HFpEF in the US is high, with some estimates exceeding 1.5 million patients. PH-HFpEF patients have increased mortality and morbidity, as well as suffer from reduced exercise capacity and quality of life. There are no drugs approved to treat this condition. If levosimendan can improve their hemodynamic function, the improvements in their quality of life could be significant.”

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on licensing, development, and commercialization of drugs that address conditions with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan and is conducting a Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

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, matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements, and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on April 2, 2018 and 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.

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