ping_pow-princess Good to hear from you...From Yahoo MB
ping_pow_princess • 1 hour 21 minutes ago
Thank you for that. I’m not sure when they would submit for the EAP but it would make sense that they would do so as soon as possible this year. It has been been stated that they plan to aggressively pursue the EAP for their products in the pipeline. From there, it is 30 day response back from the FDA; the post market clinical data must start within 6 months, if I recall. They would need to consult with the FDA on when CytoSorb can be used and how they plan to gather the post market data. The company has mentioned that they are in planning stages to run a few sepsis studies. If I were to guess about these sepsis studies, it could be for the EAP one in the US, the EU multi-center pivotal to support their findings from the first German Sepsis study (different dosage and/or patients over age 65), and perhaps as a lead clinical study investigator for the DARPA created device. They also have an international registry in place that can be used to gather the post market data.
If CytoSorb gets approved based on its usage as a cytokine reducer under the EAP, it opens it up as board usage device beyond sepsis. You may recall that the FDA has already approved the Air Force funded trauma study where the primary endpoint is myoglobin reduction, the company’s REFRESH cardiac study’s is hemoglobin and cytokine reduction. CytoSorb received CE Mark approval with reduction of iL-6 as its primary endpoint. I’ve posted this summary before.
Here is the summary on why I can see CytoSorb getting the EAP designation. The FDA would like to see reasonable assurance of safety and effectiveness for premarket approval for devices in the EAP Program.
1. CytoSorb currently targets the treatment of many life-threatening conditions such as sepsis, acute respiratory distress syndrome, severe acute pancreatitis, trauma, and many others that do not have effective treatments.
2. In 2013, the FDA approved the US Air Force and CytoSorbents pilot study using Cytosorb for the treatment of rhabdomyolysis as a result of trauma where the primary endpoint is myoglobin removal. CytoSorb received CE Mark approval with reduction of iL-6 as its primary endpoint.
3. As part of the IDE application process for the US Air Force pilot study , as per their 2013 PR, the "FDA has reviewed the CytoSorb treatment safety data from the European Sepsis Trial. We believe this early review of the European Sepsis Trial safety data will help streamline our future discussions with the FDA about a planned U.S. pivotal trial in sepsis"
4. In 2006, the original intention was to run a sepsis trial in the US. The CE Mark path would be less complex, less expensive and get the product on the market sooner, so they went this path with intentions to pursue the FDA approval after. Clinical data from the German sepsis trial was planned to be used as part of their application for the FDA pilot study whereas they can bypass the pilot study and go straight to a pivotal trial. They had discussions with the FDA as the German trial was on-going.
5. Data from the International CytoSorb registry shows the many examples where lives were saved. The registry has been developed in accordance with FDA and ICH guidelines to provide robust data on CytoSorb usage. More clinical data across many fields coming out, more investigator initiated studies underway, more publications in journals and the presentation of the data at well attended conferences by respected and some well known doctors.
6. CytoSorb has been approved with CE Mark since 2011. CytoSorb met the safety and label efficacy claim requirements of the European Medical Devices Directive.
7. CytoSorb currently used in over 200 hospitals worldwide. It is marketed in Europe, Asia, the Middle East and with plans for expansion into other countries that recognize CE Mark.
