Udenafil

SEOUL, South Korea, April 16, 2025 /PRNewswire/ -- Mezzion Pharmaceuticals, a global leader in the development of therapies for patients with single ventricle heart disease, announces a transformative milestone for the Fontan community: the introduction of new, dedicated ICD-10 diagnosis codes for Fontan-associated conditions in the U.S. Centers for Medicare & Medicaid Services (CMS) FY 2026 IPPS Proposed Rule. Listed under Table 6A of the proposed rule, the following new diagnostic codes represent the first-ever formal classification of complications specific to the Fontan circulation: I27.840 – Fontan-associated liver disease (FALD) I27.841 – Fontan-associated lymphatic dysfunction I27.848 – Other Fontan-associated condition I27.849 – Fontan-related circulation, unspecified These new codes will allow for improved clinical documentation, insurance reimbursement, and health system recognition of the unique and complex needs of patients living with Fontan physiology. "This is a monumental step forward for the Fontan community," said Dean Park, Chairman and CEO of Mezzion Pharmaceuticals. "The introduction of ICD-10 codes dedicated to Fontan-associated conditions represents long-overdue validation of the challenges faced by these patients and their families. We applaud the tireless efforts of our advocacy, clinical, and policy partners for making this achievement possible." The codes create a new branch within the ICD-10 classification system specific to Fontan physiology. This advancement will help clinicians better track and manage Fontan-related complications, fuel more accurate epidemiological research, and enable public and private payers to recognize Fontan patients as a distinct population with specific medical needs. For Mezzion, the new codes mark a significant regulatory and commercial milestone in the development of udenafil, a first-in-class therapy under investigation to improve exercise capacity in Fontan patients. Udenafil is currently being evaluated in FUEL-2, a Phase 3 confirmatory trial being conducted across the U.S., Europe, and APAC. "These codes bring clarity and structure to an area of medicine that has long lacked both. They strengthen the foundation for our continued development and future market access efforts," added Mr. Park. "As the only company solely focused on this patient population, Mezzion is proud to help lead the charge in advancing recognition, research, and treatment for those living with Fontan circulation." The proposed ICD-10 codes are open for public comment through June 10, 2025, with finalization expected by August 2025 and implementation anticipated by September 2025. About Mezzion Pharmaceuticals, Inc. Mezzion Pharmaceuticals is dedicated to improving outcomes for patients with rare congenital heart diseases. The company is advancing udenafil, a first-in-class therapy for individuals with Fontan physiology, currently in Phase 3 clinical trials. Learn more at and . Media Contacts: John Presser, EVP, CBO, [email protected] Mr. S.I. Noh, CFO, [email protected] SOURCE: CMS.gov SOURCE Mezzion Pharmaceuticals, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FORT LEE, N.J., March 1, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Continue Reading FUEL-2 Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. 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 patients that have undergone the Fontan operation, 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. Media Contacts: PR Contact – Philicia Thompson, [email protected], 7047749643 Medical Contact – John Hariadi, [email protected], (443) 699-6746 Mezzion Pharma Co. Ltd. Contact – S.I. Noh, [email protected], +82 2 560 8000 SOURCE Mezzion Pharmaceuticals, Inc