In collaboration with Baylor College of Medicine, Christus Santa Rosa Health System and Children’s Hospital of San Antonio, ViaTechMD is undertaking a second human fitment study under IRB approval FDA guidelines. This comes ahead of our second FDA Pre-submission Filing, which will include a sophisticated clinical trial proposal being designed in collaboration with regulatory experts from DuVal & Associates and JD LYMON Group, which promises to bring our groundbreaking, device-based treatment to a growing and tragically underserved patient population suffering from Preterm Labor.
Our IDE clinical trial being designed in collaboration with regulatory experts from DuVal & Associates and JD LYMON Group will be undertaken at Children’s Hospital of San Antonio’s state-of-the-art facilities, and will be overseen by the ETP Principle Investigator, Andrea D. Shields, MD, Vice-Chair, Department of Obstetrics and Gynecology, Children’s Hospital of San Antonio; Member, Medical Executive Council, Children’s Hospital of San Antonio; January 2017; and, Director of Research, Education and International Development, Department of Obstetrics & Gynecology, Baylor College of Medicine, San Antonio, TX. The ETP will also include collaboration with Dr. Brook Thomson, director of the OB Hospitalist program, and Dr. Peter Nielsen, OB-in-chief for the Children’s Hospital of San Antonio.