MAVERIC-2 trial will evaluate the impact of CardiolRx(TM) following cessation of interleukin-1 blocker therapy (rilonacept or anakinra) and is expected to run concurrently with the Company's planned ...
The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo ...