Autonomix Medical added Sandra Cohen Kalter to its board on September 18. Kalter spent nearly two decades at Medtronic and left as vice president and chief regulatory counsel, where she worked FDA strategy for renal denervation, pulsed field ablation, structural heart and transcatheter pacing. Before that she was counsel in King and Spalding's FDA practice.
Autonomix (Nasdaq: AMIX) is a development-stage company in The Woodlands, Texas. Its catheter carries a microchip sensing array that picks up individual nerve signals from inside a blood vessel, finds the overactive ones, ablates them and then checks whether the signal is gone. The first clinical work is in pancreatic cancer pain and pancreatitis.
A company this small putting a regulatory lawyer on the board says something about where it thinks its risk sits. Transvascular nerve sensing has no clean predicate, and the four programs on Kalter's Medtronic resume are all ones where the regulatory path, not the engineering, set the timeline.