CytoSorbents Corporation (CTSO)

[ping_pow_princess]

The Zacks report talks about the FDA trial on page 4.

"As such, CytoSorb targets a multi-billion dollar total addressable market where very few treatment alternatives exist. The route for U.S. regulatory approval (the initial U.S. target indication would likely be sepsis) would likely be the PMA pathway - which will require the company to conduct U.S.-based clinical trials - the scope, size, duration, cost, etc. of which are unknown but which may become more clear in the coming months. In 2007 the FDA approved an IDE for CytoSorbents to conduct a small U.S. sepsis safety study. Given the positive results of the European sepsis trial and the fact that the European trial incorporated much of the FDA's guidance from the IDE, CytoSorbents now hopes to use their positive European trial data to request an IDE modification to allow for U.S. efficacy-powered
studies which would eventually support a PMA filing. CytoSorbents hopes to have the IDE amended for approval of either a large (~ 300 - 500 patients) pivotal study or a more targeted study (~150 patients) stratified for mortality risk factors (such as age and cytokine levels). Assuming positive results, CytoSorbents would then use data from one or more of these studies to support an eventual PMA submission. While a smaller study would incorporate a more narrow indication (e.g. aged 65 and over), it would likely require significantly less time and money to complete than
would a larger study with a more diverse patient population. In addition, a more narrow indication would not necessarily meaningfully limit the commercial opportunity in the U.S. as physicians could use the device outside the approved indication (i.e. - off-label) and the vast majority of sepsis patients are 65+ years old and/or have elevated cytokine levels anyway. CytoSorbents hopes to meet with the FDA to discuss a possible modification to their IDE in the near-term (specific timelines have not been announced)."

http://scr.zacks.com/Theme/Zacks/files/June%205,%202012_CTSO_Initiating%20Coverage_Marckx_v001_d9enrx.pdf

As for theranostics study, two high risk groups from the EU trial, those with high cytokine levels and those age 65+. He defined high cytokine levels as highly elevated levels of IL-6 (=1,000 pg/mL) or IL-1ra (=16,000 pg/mL). These information are from their product brochure and his presentations. I’m thinking they will have a test for cytokine levels and then decide on a which dosage to apply to the patient - the standard or the more aggressive. If the patient shows levels of IL-6 (=1,000 pg/mL) or IL-1ra (=16,000 pg/mL), then they are enrolled in the more aggressive treatment which could perhaps be more than 12+ hours per day or more than 7 days of treatment. If levels are less, patients probably go through the standard 6 hr per day for the 7 days.