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Tenax Therapeutics Announces New Clinical Study Publication Results Indicate Levosimendan Offers Renal Protective Benefits to Heart Failure Patients

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  • Results indicate levosimendan increases glomerular filtration rate
    (GFR)
  • Levosimendan may be a preferred drug for heart failure patient with
    impaired renal function

Tenax Therapeutics, Inc. (NASDAQ:TENX) today announced the results of a
new study titled "Differential Effects of Levosimendan and Dobutamine
on Glomerular Filtration Rate in Patients With Heart Failure and Renal
Impairment: A Randomized Double‐Blind Controlled Trial"
were
published in the August 21, 2018 issue of the Journal of the American
Heart Association (https://www.ahajournals.org/doi/full/10.1161/JAHA.117.008455).
The results indicate that levosimendan offers unique renal protective
benefits to patients who have heart failure and coexisting impairment of
their kidney function.

The study authors (Lannemyr, et al) note "this study is the first
evaluating the differential effects of levosimendan and a catecholamine
on measured RBF, GFR, and renal oxygenation in patients with HF and
renal dysfunction." Renal impairment is a common comorbidity seen in HF
patients and is a strong predictor of their mortality. This study
provides evidence of a mechanistic explanation for direct renal
protective effects that is based on the unique K-ATP channel mechanism
of levosimendan. The findings of this study are consistent with previous
studies that provide evidence that levosimendan improves GFR and other
metrics of renal function in heart failure patients. These facts
contributed to the authors' conclusion that levosimendan may be a
preferred drug for heart failure patient with impaired renal function.

The study enrolled 32 patients with HF and renal impairment in a
randomized, double-blind, controlled design and compared the acute renal
and systemic effects of moderate doses of levosimendan (0.1 µg/kg per
minute) and dobutamine (7.5µg/kg per minute). Both agents induced a
renal vasodilation and increased RBF to a similar extent. However, only
levosimendan treated patients experienced an increase in GFR (22%,
P=0.012). In contrast, dobutamine treated patients experienced no
improvement in GFR.

Anthony DiTonno, CEO of Tenax Therapeutics, stated "The results of this
new study are encouraging. These findings are consistent with earlier
studies and potentially very relevant to our current levosimendan
clinical development plans in heart failure patients with pulmonary
hypertension and preserved ejection fraction (PH-HFpEF). Heart failure
patients commonly suffer from renal dysfunction and should benefit from
the unique renal protective benefits that levosimendan appears to
provide heart failure patients, including PH-HFpEF patients with renal
impairment."

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused
on identifying, developing and commercializing products for the critical
care market. 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 in the start-up stage of 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, 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 April 2, 2018, its quarterly report on Form 10-Q
filed on August 14, 2018 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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