Helios Cardio Announces First Patient Enrolled in FDA Investigational New Drug (IND) Study of CardiaMend™ and Amiodarone for Postoperative Atrial Fibrillation Prophylaxis
Weston, Massachusetts – January 3, 2025 – Helios Cardio Inc., a commercial-stage biopharmaceutical company focused on developing innovative solutions for cardiac surgery, today announced the successful enrollment of the first patient in its landmark Phase 1/2 clinical trial evaluating the safety and efficacy of CardiaMend™ in combination with amiodarone for the prevention of postoperative atrial fibrillation (POAF). This Investigational New Drug (IND) study, registered as NCT06730828, marks a significant milestone in developing a potential new approach to addressing this common and serious cardiac complication.
POAF is a frequent occurrence following cardiac surgery, affecting up to 60% of patients. It is associated with increased morbidity, mortality, and healthcare costs. CardiaMend™, a novel epicardial patch derived from fetal bovine extracellular matrix, is designed to reduce inflammation and oxidative stress on the surface of the heart, potentially mitigating the risk factors associated with POAF. This study will investigate its synergistic potential with the local delivery of amiodarone, a commonly used antiarrhythmic drug.
Yiannis Monovoukas, PhD, MBA, President and CEO of Helios Cardio, said, “The initiation of this IND study is a crucial step forward in our mission to improve patient outcomes following cardiac surgery. We are excited about the potential of CardiaMend™ to address a significant unmet need in the prevention of POAF and look forward to the results of this important clinical trial.”
The study will enroll 80 subjects undergoing cardiac surgery at The University of Louisville under the direction of Mark Slaughter, MD.
About CardiaMend™
CardiaMend™ is an epicardial patch composed of decellularized fetal bovine dermis, a material with a rich heritage of exceptional clinical safety and performance in over 1 million patients in critical applications such as dura mater repair, hernia repair, and plastic and reconstructive surgery.
About Helios Cardio Inc.
Helios Cardio is a privately held commercial-stage biopharmaceutical company dedicated to developing innovative therapies for cardiac surgery. The company focuses on leveraging the unique properties of decellularized fetal bovine dermis to create treatments that improve patient outcomes and address unmet needs in cardiovascular care.
