Katherine Kumar Ph.D

Katherine Kumar Ph.D General Information

Biography

Dr. Katherine Kumar served as Vice President Clinical & Regulatory Affairs at TVA Medical. She also served as Clinical & Regulatory Advisor and Board Member at Inspired Life Medical. She is an experienced leader in clinical strategy and regulatory affairs. Most recently, Katherine was Sr. Director of Science & Clinical Affairs at Cardiovascular Systems Inc. (NASDAQ: CSII) where she was responsible for clinical study development and execution, all scientific activities and, the bridge between clinical and marketing activities. Katherine's ability to quickly assess business needs led to the establishment of a growth-oriented clinical strategy and clinical operations and science teams. Amongst the most notable achievements was a "findings free" FDA BIMO audit for the pivotal coronary artery PMA trial. The quality execution of this trial resulted in one of the fastest PMA approvals in the history of coronary artery devices. Prior to CSI, she was with the Medrad Interventional/Possis business unit of Bayer HealthCare, leading the clinical efforts for the combination product division focused on developing drug-coated balloons. Katherine also held clinical positions with American Medical Systems, and several startup companies developing various therapeutic devices worldwide.