InGeneron has introduced its system into the U.S. Food and Drug Administration?s (FDA) regulatory process to ensure it is safe and effective. Successfully attaining FDA approval will allow us to market our regenerative cell therapy for specific indications in the United States.
Our products have been available for us in Europe since 2014. Our quality management system is EN ISO 13485:2016 certified, and the medical devices carry a CE Mark. This mark shows that our product meets all of the applicable health, safety, and environmental protections that were required at the time of manufacturing and that conform to the standards of European Union regulations.
InGeneron is a cell therapy company that enables novel, evidence-based treatments designed to heal certain chronic conditions using a patient?s own regenerative cells processed at the bedside for same-day application. We produce a platform of medical devices that process adipose (body fat) t