CytoSorbents Corporation (CTSO)

[stingman49]

.From Dr. Chan: In terms of the Cures Act, the portion that is relevant to medical devices is an extension of the EAP pathway that we tried to pursue for sepsis in 2015, but now allows 510(k) applications to participate. Unfortunately at that time, the FDA required that we would need to demonstrate 28-day mortality benefit, which offered us no benefit. The new program does not really change this path, but may offer the opportunity to pursue other applications of the CytoSorb technology. There have only been 17 devices/diagnostics accepted to the EAP program in the past nearly 3 years, so not a prolific program.

There are other provisions, such as an openness to patient advocacy, but critical illness is not a chronic disease where there are many advocates. There are also some provisions trying to compel the FDA to follow its own Least Burdensome Requirements, so we will see where this goes.

Ultimately, there may be some benefit, in terms of more money towards research, and potentially the greater receptiveness of the FDA to real world data, but ultimately not much more impact than the original EAP guidance.