Tenax Unveils Revolutionary Patent for Treating Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF).

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company dedicated to developing and commercializing products that address critical cardiovascular and pulmonary diseases with high unmet medical need, is proud to announce that the USPTO has issued them a patent for the use of IV levosimendan in the treatment of pulmonary hypertension associated with HFpEF. U.S. Patent No. 11,607,412, entitled “Levosimendan For Treating Pulmonary Hypertension With Heart Failure With Preserved Ejection Fraction (PH-HFpEF)”, is a major milestone in Tenax’s mission to improve the lives of those suffering from cardiovascular and pulmonary diseases.

The Company has now secured a new patent for the use of levosimendan, providing them with substantial added intellectual property protection up until December 2040. This advanced patent builds upon their existing IP for levosimendan, which includes U.S. Patent No. 11,213,524 issued in January 2022, giving them coverage for all medical uses of the subcutaneous formulation of levosimendan in humans.

With this new patent in place, the Company is now even better equipped to provide their customers with the highest quality of care and treatment.

Tenax Therapeutics is thrilled to announce the issuance of U.S. Patent 11,607,412, which covers the use of IV levosimendan to treat pulmonary hypertension-heart failure with preserved ejection fraction (PH-HFpEF). This new patent adds to Tenax’s rapidly growing IP foundation and serves as a strategic asset as Tenax continues to advance levosimendan through clinical trials and explore partnering opportunities.

The issuance of the patent confirms the innovative nature of Tenax’s work and sets the precedent for action in their pending U.S. patent application for an oral formulation (TNX-103) in the same patient population. According to Tenax’s President and Chief Executive Officer, Chris Giordano, “Tenax is building a solid patent estate surrounding levosimendan, and this new patent is an important milestone in our mission to bring novel treatments to patients who need them.”

The HELP Study results revealed that levosimendan, a unique cardiovascular drug, could be a potential breakthrough for patients suffering from PH-HFpEF. These patients, who currently have no FDA approved therapies, saw a significant improvement in their 6-minute walk distance of 29 meters (p=0.03) when compared to placebo.

Furthermore, as patients transitioned to an oral formulation after the weekly IV regimen, their 6-minute walk distance further improved. The FDA has acknowledged the 6-minute walk distance endpoint as a suitable one for a Phase 3 registration program, further validating the efficacy of levosimendan in treating PH-HFpEF.

Levosimendan is a remarkable agent, setting itself apart from any other therapy tested in patients with PH-HFpEF. According to Tenax Therapeutics’ Chief Medical Officer, Dr. Stuart Rich, levosimendan is the only potential therapy that combines K+ATP channel activation and Ca++ sensitization, two key mechanisms of action that have been proven to enhance symptoms and exercise tolerance in these patients.

About Levosimendan (TNX-101, TNX-102, and TNX-103)

Levosimendan, an innovative potassium ATP channel activator and calcium sensitizer, is revolutionizing the way we think about the heart and vascular system. Developed by Orion Corporation in Finland and now approved in over 60 countries, this intravenous therapy is being studied by Tenax Therapeutics as a potential groundbreaking treatment for pulmonary hypertension and heart failure with preserved ejection fraction.

Results of their Phase 2 trial suggest that levosimendan can significantly improve patients’ exercise capacity, a discovery that has the potential to change the lives of those suffering from this debilitating condition. No other drug therapy has been able to provide this level of relief, making levosimendan a much-needed breakthrough in cardiovascular care.

About Imatinib (TNX-201)

Tenax Therapeutics is on a mission to revolutionize the treatment of pulmonary arterial hypertension (PAH). In March 2020, the FDA granted Tenax orphan designation for the development of a novel dosing and unique formulation of the kinase inhibitor imatinib mesylate. The previous Phase 3 trial, IMPRES, showed that patients taking the full dose of imatinib experienced a greater and longer-lasting improvement in exercise tolerance than with any other PAH treatment.

As no existing treatment has been able to halt progression or induce regression of the disease, imatinib has the potential to be a game-changer, by targeting the cellular pathways associated with PAH. With Tenax’s innovative approach, the potential for a new disease-modifying therapy for PAH is on the horizon.

About Tenax Therapeutics

At Tenax Therapeutics, Inc., we are passionate about developing and commercializing innovative treatments for cardiovascular and pulmonary diseases with high unmet medical need. We are proud to own North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan, as well as a unique oral formulation of imatinib. Our goal is to provide patients with alternative treatments to improve their quality of life.

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