You know times are tough for medtech start-ups in the US when even a successful serial entrepreneur like Michael Lesh, MD, is told by VCs, “We love the technology, haven’t seen anything like it, but it’s too early for us.” Generally speaking, VCs don’t like early stage companies as much as they used to, and they’re avoiding the kinds of implant companies that are subject to the PMA regulatory process, since, in having to navigate the highest hurdles at the FDA, getting these products to market costs more time and money than limited partners can stomach these days.
Lesh is, of course, the successful electrophysiologist/entrepreneur who founded atrial fibrillation company Atrionix Inc., which was sold to Johnson & Johnson in 2000, [See Deal] mitral valve repair...