Innovation The study device, named the HemiBridgeTM System, is the result of extensive pre-clinical research and development initiated by Donita Bylski-Austrow, PhD and Eric Wall, MD both of Cincinnati Children's Hospital Medical Center and the University of Cincinnati. Research and development of the study device to date has used an interdisciplinary team, including pediatric spine surgeons, engineers, scientists and regulatory experts. This team has helped define the compressive loading required to alter growth, tested prototype devices in preclinical models, improved the test articles for clinical use, and confirmed repeatable in-vivo results in compliance with FDA Good Laboratory Practices. This process has led to the approval of a study device that has achieved FDA and IRB approvals to begin clinical phase testing.