CytoSorbents Corporation (CTSO)

[ping_pow_princess]

The company has publicly stated that they plan to run a pivotal trial to gain approval in the US. It will go through a PMA process because it is a high risk device under Class III. The costs associated with PMAs are high because of the clinical trial that needs to run. (The application cost alone from the FDA is approx 65K for small businesses or 250K for larger businesses.) Additionally, I'm not sure what the exact plans are, but they intend to run more than the 2 studies (US approval + the US air force) that have been publicly stated in the country of United States. We should hear more about that later.