Big Win for Tenax Therapeutics: USPTO Grants Patent for Oral Levosimendan (TNX-103) to Treat Pulmonary Hypertension & Heart Failure!

Tenax Therapeutics, formerly known as Oxygen Biotherapeutics, Inc., has been granted a Notice of Allowance by the USPTO for its patent application that covers the use of TNX-103, an oral levosimendan, for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). This newly approved product offers individuals with this condition an effective treatment option and opens the door to potential relief and improved quality of life.

Tenax is thrilled to have secured patent protection in the United States for its groundbreaking use of oral, subcutaneous, and intravenous (IV) administration of levosimendan to treat PH-HFpEF. The exclusive IP rights will last through 2040, allowing Tenax to better protect its innovative technology and giving the company a substantial competitive advantage in the marketplace.

Today, Tenax Therapeutics is thrilled to announce the issuance of a Notice of Allowance for a new patent protecting oral levosimendan until the end of 2040. This breakthrough marks an exciting development for the company, positioning them to capitalize on the significant potential of the daily, oral formulation, and take the next step of launching Phase 3 studies to treat PH-HFpEF, a heart condition impacting millions of people in the US with no available FDA-approved treatments. We can’t wait to see what the future holds!

Today, Tenax and our outside IP counsel are celebrating a major milestone! After several years of hard work, we have secured our levosimendan IP estate. This accomplishment marks a leap forward in our commitment to grow shareholder value by tackling a monumental unmet need in cardiovascular medicine.

With these IP rights now firmly in place, we can progress oral levosimendan into Phase 3 testing and keep shareholders updated on our progress. We are truly thankful for the dedication and diligence shown by our Tenax colleagues and IP counsel.

Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics, is enthusiastic about the potential of oral levosimendan to become the first treatment ever approved for the treatment of PH-HFpEF, the most common type of pulmonary hypertension globally.

The Phase 2 HELP Study revealed that intravenous levosimendan is the only drug to improve exercise capacity in this patient population, and even received guidance from the FDA that the same 6-minute walking test can serve as the primary endpoint in their Phase 3 program.

With remarkable mechanistic properties as both a potassium ATP channel activator and calcium sensitizer, oral levosimendan is a unique and promising candidate for use in the treatment of the disease.

The findings of the HELP Study have revolutionized the treatment of PH-HFpEF, thanks to the patent-protected use of oral levosimendan. In the study, patients experienced a 29 meter improvement in 6-minute walk distance when administered levosimendan compared to the placebo group. By transitioning to oral daily consumption of levosimendan, the results were improved even further — an exciting development for those suffering from PH-HFpEF.

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

Levosimendan, an innovative potassium ATP channel activator and calcium sensitizer, approved in more than 60 countries, is making waves with its potential to address the needs of patients suffering from pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF).

The findings of Tenax Therapeutics’ Phase 2 trial of levosimendan demonstrate the drug’s aptitude for producing potent dilation of the central and pulmonary venous circulations, translating into improved exercise capacity. This pivotal discovery paves the way to a potential groundbreaking therapy, offering a glimmer of hope to combat the growing epidemic of PH-HFpEF, a deadly condition that currently has no, safe and effective, treatment.

About Imatinib (TNX-201)

Tenax Therapeutics is pioneering the development of an innovative dosing and formulation of Imatinib mesylate, which was granted with the FDA’s orphan designation in March 2020 for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a former Phase 3 trial, has revealed a striking and enduring effect of oral imatinib in improving exercise tolerance compared to any other available medications for PAH, whether taken alone or in a combination.

Despite the availability of several pulmonary vasodilators, no existing treatment has the ability to stop the progression or cause risk of the disease. Imatinib, however, acts on the cellular proliferative pathways linked to PAH, offering a chance for the FDA to approve it as the first disease-modifying therapy for PAH.

About Tenax Therapeutics

Tenax Therapeutics is at the forefront of developing highly-effective treatments for cardiovascular and respiratory diseases. With a focus on ensuring unmet medical needs are addressed, the company has acquired the exclusive rights to develop and commercialize subcutaneous and oral formulations of levosimendan and an oral formulation of imatinib.

With these cutting-edge formulations, Tenax Therapeutics is leading the way in innovating solutions that improve the quality of life for those affected by these illnesses. Nasdaq has recognized the company’s potential and is now listing Tenax’s common stock under “TENX”.

Caution Regarding Forward-Looking Statements

Tenax Therapeutics is engaging in forward-looking statements to assess the potential outcomes of its business strategy. However, these outcomes may vary due to many factors, which may include intellectual property risks, delays in regulatory review and approval of product candidates, competitive position, the potential market opportunity, and the impact of the COVID-19 pandemic.

Tenax Therapeutics is committed to ensuring sustainable operations and is actively working to recruit the qualified personnel and advisors needed to meet its goals. As such, the company will remain accountable to the relevant legal, regulatory, and legislative changes that may arise.

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