Juli 10, 2023
MyoPax Receives FDA Rare Pediatric Disease Designation

We are excited to announce that MyoPax has been granted the Rare Pediatric Disease Designation by the U.S .Food and Drug Administration.

This FDA designation marks a major step forward in our mission in utilizing our proprietary technologies to repair a congenital muscle defect and restore continence in children diagnosed with Exstrophy-Epispadias-Complex. We are proud to be pioneering new frontiers and addressing an unmet medical need and pediatric disease.
The FDA acknowledgment recognizes the potential impact our new therapeutic modality may have on the lives of young patients and their families.

„Receiving the RPDD from the FDA is a significant milestone,” said Simone Spuler, co-founder and Professor of Myology. “It reflects the urgency and importance of our work in developing a transformative treatment for EEC and beyond. Muscle disorders encompass many devastating genetic and acute diseases for which today there are only supportive therapies.”

This significant milestone underscores our commitment to leveraging our innovative technology in restoring muscle function for individuals affected by muscle diseases.