CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to treat life-threatening illnesses. These are common, major conditions seen in the intensive care unit (ICU), such as sepsis and infection, severe trauma, burns, lung injury, and pancreatitis, that afflicts millions of people each year yet lacks effective therapies, leading to a mortality rate that often exceeds 30%. Failure of multiple organs, such as the lungs, heart, kidneys and liver, is the leading causes of death from these conditions, for which very little can be done today. Hospital acquired infections are another leading cause of death in the ICU. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster.
On Seeking Alpha, VFC's Stock House wrote an article discussing the reasons a company might choose to seek drug approval overseas before pursing the US market. In the case of Ampio Pharmaceuticals (AMPE), for example, "the reason why Ampio is not seeking a US approval for Zertane in the treatment of PE is quite simple - the FDA does not recognize the condition as a medical need." He noted that "Cytosorbents Inc. (CTSO) is another company that keyed in on Europe before setting sights on the US market."
He explained,
"There is little doubt that when it comes to making money in the pharmaceutical and health care industries, the US market is the place to be. Companies know that and investors thrive on making money based on that fact. That said, contrary to the belief of some, there is a whole wide world out there other than the United States, and in many cases it is cheaper to do business and conduct trials overseas than it is back home...
The more cautious investor may shy away from investing in a company that looks to see if a product works overseas first before then concentrating on the FDA in an effort to save a few dollars, but others may be attracted to a business model that might not leave a company as exposed to the loan shark financing deals that are prevalent in the US to keep the early stages of the pipeline going."