ping_pow_princess-Yahoo Message Board-very good write up.
A few things to note by today's PR is very positive as it is one of many pieces coming into place.
In Q1, they hired a Clinical trials manager devoted to work on US cardiac surgery trial and the US Air Force trauma trial. They plan to submit an IDE this summer, of which I think they have already done because they had this data in their hands before today's publication came out along with some of the data from their international patient registry.
The International CytoSorb Registry began with two major patient groups: Severe Sepsis/Septic Shock and Cardiac surgery patients. The data can be used to guide future therapy, be used to publish papers and abstracts, and be used to support regulatory filings for device approval. From the Q4 2013 conference call, Dr. Steiner says this: “The next evidence layer, the International CytoSorb Registry, should be online by the end of Q2 this year. It took massive efforts to set up this high quality medical registry, which also fulfills FDA requirements and is led by the world-renowned sepsis researcher Prof. Brunkhorst and his Study Center at the U. of Jena. This will give us the opportunity to very quickly collect data from nearly all treated patients on an international basis. Also we will have the ability to embed randomized studies into this registry.”
Out of the 30 investigator initated studies in the EU, there are 11 studies in the peri-operative application of CytoSorb in cardiac surgery patients, of which two randomized controlled studies will be finishing recruitment in Q2 and Q3 of this year.
Positives about the switch from sepsis to cardiac surgery, "So, although early, the initial experience with many cardiac surgery patients has been very promising. Clinical trials can be done very rapidly in this space. A typical center can do three to five cardiac surgeries per day, and so you can really rack up many patient experiences in a very short period of time. And, cardiac surgery represents a total addressable market of more than $500 million in the U.S. and Europe alone, particularly if we can establish CytoSorb® as standard of care therapy. And interestingly, it is a market that sits separate from critical care, and represents a completely separate market opportunity for CytoSorb® and could represent a beachhead for us to work off of as we approach more risky applications."
Some other points:
* Endpoint for US cardiac surgery will not be mortality, rather the incidence of respiratory failure or acute kidney injury which is much easier to prove.
*Patients often develop inflammation due to cytokine storm and free hemoglobin release during the surgery
*Organ dysfunction and failure, particularly lung and kidney failure, frequently result
*No technology has been able to easily and directly reduce cytokine storm and free hemoglobin
New! Cytosorb In Cardiac Surgery KardioTechnik 2014[b]
Seems to me that they probably already submitted the IDE application for the FDA. Using the data from this study, they would bypass the required pilot study and go straight to a pivotal trial. We should hear back soon. When the company submitted back in 2007, I think it took a few months to hear back from the FDA
8 hours ago
Things could change 7 years later but the timeline for IDE approval was indeed a few months back in 2007. Submitted IDE application on Dec 29, 2006. Was approved in Q1 2007 for an initial 5 patients (with room to add more patients from one of their other PR) to start for the pilot study. For US approval, a pilot study first, then a pivotal trial.
On January 4, 2007, the company issued a PR: "MedaSorb Technologies Corporation (OTCBB: MSBT) announced that is has submitted an Investigational Device Exemption (IDE) Supplement to the FDA for its CytoSorb hemoperfusion blood filtration device.
The IDE application addresses the use of CytoSorb(tm) for the treatment of Acute Respiratory Distress Syndrome (ARDS) caused by sepsis. The filing, which includes a proposed pilot study, was delivered to the FDA on December 29, 2006. If the proposed pilot study is approved by the FDA, MedaSorb intends to commence clinical trials by the third quarter of 2007."
From a 2007 filing: " In the first quarter of 2007, the Company received approval from the FDA to conduct a limited study of five patients in the adjunctive treatment of sepsis. The Company had also been pursuing approval to conduct clinical trials in Europe with the ultimate goal being to obtain a CE Mark for its CytoSorb™ device. In August of 2007, the German Ethics Committee approved MedaSorb’s application to proceed with a clinical trial enrolling up to 80 patients with acute respiratory distress syndrome or acute lung injury in the setting of sepsis. The Company estimates that the market potential in Europe for its products are substantially equivalent to that in the U.S. Given the opportunity to conduct a much larger clinical study in Europe, and the Company’s belief that the path to a CE Mark should be faster than that of an FDA approval, MedaSorb intends to launch its next clinical study in Germany. The Company will, however, continue to work with the FDA and keep the FDA informed of its progress with its European clinical trial.
