The second phase of the strategy is to work with distributors or strategic partners to expand the commercial footprint of CytoSorb® to the rest of Europe and to other countries that accept European regulatory approval. This will allow us to leverage their pre-established sales force and distribution capabilities, including important KOL contacts, enabling broader CytoSorb® filter sales.
By layering these two sources of revenue with grant income from government R&D contracts, we hope to accelerate our revenue growth and time to cash flow breakeven. If our European strategy is successful, it would provide an abundance of opportunities for the Company. We estimate that Germany alone represents a total addressable market of at least $500 million to $1 billion for critical care applications. However, to further drive success of the Company, we plan to pursue U.S. regulatory approval for CytoSorb®. We intend to leverage our existing FDA approved IDE application (to run a small sepsis trial), to run a larger pivotal trial in the U.S. The timing of a trial in the U.S. is subject to many variables, and we are working through those now with the intent of conducting detailed discussions with the FDA regarding trial design later this year. Should a pivotal trial be successful in the U.S., it could lead to U.S. FDA approval and be yet another major catalyst to CytoSorb® adoption and usage worldwide.
With each new CytoSorb® treatment, we learn more about how best to use it. In our ongoing dosing study, CytoSorb® has been successfully used with continuous treatment (each cartridge used for 24 hours) for 7 days with no serious device related events. The trial is ongoing, with additional patients being enrolled, samples collected and data being analyzed. We are currently expanding the study to include a total of seven hospitals in Germany, all of which are leading university hospitals that expressed an interest to join our trial. We are also using the trial as an opportunity to answer some important questions related to treatment, which will be helpful to further guide clinical usage.
Outside of the trial, in every day clinical practice, physicians have had generally encouraging results with CytoSorb®. For example, there have been a number of cases of septic shock and multiple organ failure where CytoSorb® was used in patients with extremely high cytokine levels (e.g. IL-6 greater than 20,000 pg/ml). These patients were extremely sick with a variety of infections ranging from a Streptococcal limb infection to suspected gram negative sepsis following complications from a gynecologic procedure. In each of these cases, the prognosis was reportedly grim by the treating physicians. With CytoSorb® treatment, IL-6 levels dropped dramatically over the course of several days, with an eventual resolution of organ failure, and patient recovery. Based upon feedback from these physicians, they are interested in documenting these surprising results for potential publication.
There have also been a handful of cases, unfortunately, where CytoSorb® has not been able to rescue the patient. A common theme in these treatment failures appears to be either suboptimal usage of CytoSorb® or treatment that was too late in the disease process. We cannot expect CytoSorb® to save all patients, particularly when patient's illnesses are so advanced that recovery is unlikely. That said, the more clinical experience we gain with the technology, the better the odds of treating these patients optimally and having a better clinical outcome.
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