Tenax Therapeutics, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of TNX-103, oral levosimendan, titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” The patent, once granted, will have a patent term through December 2040. It will provide the Company with substantial added intellectual property (IP) protection in the United States; Tenax will now have secured IP rights surrounding the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan for the treatment of PH-HFpEF. The patent covering the use of oral levosimendan for the treatment of PH-HFpEF is based on key discoveries from the HELP Study, in which levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when compared with placebo.

When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further.