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Tenax Therapeutics Announces Presentation of 24-Hour HELP Study Results at the American Heart Association Scientific Sessions 2020

MORRISVILLE, N.C.–()–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that data from the 24-hour open-label portion of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be presented during the American Heart Association (AHA) Scientific Sessions 2020 that is being conducted online from November 13, 2020 – November 17, 2020.

The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan’s hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the prespecified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.

The 24-hour HELP Study results being presented at AHA include data from a total of 44 patients, of which 36 (~85%) were determined to be responders. Details regarding the presentation are as follows:

 

Title:

24-hour Levosimendan Infusion Decreases Biventricular Filling Pressures at Rest and Exercise in PH-HFpEF

 

Author:

Daniel Burkhoff, MD PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al

 

Session:

Novel Translational Insights for Pulmonary Vascular and RV Remodeling

 

Date/Time:

Available OnDemand beginning Friday, November 13, 2020 at 9:00 a.m. CST

 

The above presentation will be available to conference registrants for viewing on the AHA Scientific Session’s Virtual Platform at https://professional.heart.org/es/meetings/scientific-sessions.

Tenax Therapeutics’ CEO, Tony Ditonno, stated, “We are very excited to have these additional HELP Study results presented at the American Heart Association meeting. The results are very complimentary and supportive of the 6 week-double blind randomized phase of the HELP Study that was recently presented as a late-breaking clinical trial at the Heart Failure of Society of America, and we are very excited to have this additional 24-hour data being shared at this major scientific forum.”

About Phase 2 HELP Trial

The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their 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 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, 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; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; 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 March 30, 2020, and its quarterly report of Form 10-Q filed on August 14, 2020, 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.

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