The American Heart Association ("AHA") Recognizes Mezzion's FUEL Trial as the Biggest Victory in Congenital Heart Disease ("CHD") Advancements for 2019

The National Heart, Lung, and Blood Institute ("NHLBI") also Recognizes the FUEL Trial as an Advancement in CHD for 2019

News provided by

Mezzion Pharma Co. Ltd.

Jan 09, 2020, 13:00 ET

DEERFIELD, Ill., Jan. 9, 2020 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410: KOSDAQ) is pleased to announce that the AHA, one of the top funders of heart- and stroke-related research worldwide, selected Mezzion's FUEL Trial that concerns the treatment of single ventricle heart disease ("SVHD") adolescents who have undergone Fontan palliation with udenafil that showed improvement in exercise performance, as published in Circulation, as one of the top advances for 2019.

The AHA has been compiling an annual list of major advances in heart disease and stroke science since 1996 and Mezzion's FUEL Trial was selected as one of the biggest victories for 2019, grouped into 10 subject areas. See https://www.heart.org/en/about-us/scientific-research/aha-names-top-heart-disease-and-stroke-research-advances-of-2019.

"Mezzion is honored that the AHA has selected the FUEL Trial as the major advance in the congenital heart defect category for 2019. This AHA recognition highlights Mezzion's pioneering advance involving the treatment of Fontan patients with udenafil and Mezzion's dedication to the SVHD community," said Mr. D. Park, CEO, Mezzion Pharma Co. Ltd.

Mezzion is further honored and pleased to announce that the NHLBI of the National Institutes of Health ("NIH") has also recognized Mezzion's FUEL Trial as an advancement in CHD in 2019. Specifically, the NHLBI stated in Advancing Heart, Lung, Blood, and Sleep Research (January 2020) that the FUEL Trial "…showed a significant improvement in [Fontan teenagers'] ability to sustain moderate exercise after treatment with udenafil, a drug that helps improve blood flow." See page 3, https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/advancing-heart-lung-blood-and-sleep-research-0.

Mezzion Pharma Co. Ltd.

Mezzion Pharma Co. Ltd. is headquartered in South Korea. Mezzion Pharma and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ).

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of Fontan patients to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel.

These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:

Dr. James Yeager, Deerfield, Illinois, USA, Tel: +1-847-2122679

Email: [email protected]

Mr. YT Song, Seoul, Korea, Tel: +82 2 560 8011

Email: [email protected]

SOURCE Mezzion Pharma Co. Ltd.