Medical device company CytoSorbents (OTC: CTSO) has developed a filtration system for the blood to treat the root cause of sepsis for some of the most vulnerable patients in a hospital — those in the intensive care unit. Its device uses polymers to “absorb” excessive levels of cytokines in the blood as well as harmful substances, such as bacterial toxins, in the blood.
The developers view CytoSorb as having the potential to be an effective treatment against sepsis and prevent multiple organ failure, caused by the overreaction of the immune system in response to infection, referred to as cytokine storm or cytokine cascade.
The device uses porous polymer beads the size of a grain of salt. Here’s how it works. A temporary dialysis catheter would be inserted into a vein, and the filtration system would be connected to the dialysis machine. Blood would be pumped out of the body and through the filter. For each procedure a new filter cartridge would be used. The company maintains that it can reduce the amount of cytokines by at least 50 percent.
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Although cytokine are proteins that help stimulate and regulate the immune system, an excessive amount can be harmful and lead to organ failure.
The target patient population is 65 years old and older since they are most vulnerable and have co-morbidities that make them more susceptible to sepsis, particularly pneumonia. About two thirds of sepsis cases are patients in this age range. Although it sees its device as being able to significantly reduce hospitalization costs caused by sepsis, and organ failures, it believes there are many other areas where it could be used sees its filter system as a way to tackle other medical issues such as pancreatitis, liver failure and for surgery.
Having received a CE Mark for its device in Europe in 2011, Cytosorbents is in expansion mode there — it’s been marketing CytoSorb in Germany, Austria, Switzerland and most recently in the UK. Now it is seeking FDA clearance for the device. CEO Dr. Phillip Chan said it has an approved Investigational Device Examination to do a small sepsis trial in the U.S., and plans to convert that into a pivotal trial IDE. Then it would begin a Premarket Approval trial in 2014 — a move that would cost about $8 million to $12 million and take two to three years. “We are the only ones to have specific approval for a cytokine filter,” in Europe, Chan said.
Prior to starting the Monmouth Junction, New Jersey company, Chan served as the co-founder of Andrew Technologies and commercialized a lipoplasty device called HydroSolve which receive 510(k) clearance from the US Food and Drug Administration in 2010. He also is a former partner at NJTC Venture Fund where he led life science investments for five years. CytoSorbents s one of the fund’s portfolio companies, as is Andrew Technologies.
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Last year CytoSorbents received a $3.8 million five year DARPA grant as part of its “Dialysis-Like Therapeutics” program to treat sepsis to remove cytokines and bacterial toxins. A few months later it was awarded a $1 million Phase 2 SBIR Trauma and Burn grant to research how its filter could be used to help burn victims vulnerable to infection.
European medical device companies have also been developing ways to address the cytokine storm that can cause multiple organ failure. Gambro‘s “dialyzer” to filter out cytokines called Nephral and Italian company Bellco’s CPFA devices are intended to counter the inflammation suffered in multiple organ failure.
The cost of treating sepsis was $14.6 billion in 2008, according to the Centers for Disease Control. Several companies are developing approaches to combat sepsis from therapeutics from BioAegis Therapeutics to preventive measures to flag up vulnerable patients earlier.