In a recent interview, MedaSorb Technology Corporation’s (OTC:MSBT) Chief Executive Officer, Dr. Phillip Chan, said in a recent interview that if European trials for its flagship product CytoSorb™ in Germany prove as successful as expected, the Company could receive EU approval and begin commercialization late this year.
CytoSorb™ is a novel blood purification device designed to treat people afflicted with severe sepsis. Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza. This devastating syndrome is characterized by an overwhelming systemic response to infection, which can rapidly lead to organ dysfunction and ultimately death. Dr. Chan cited alarming statistics regarding sepsis.
“Over 1 million people are afflicted with severe sepsis in the U.S., 1.5 million are affected in Europe and an estimated 18 million are affected worldwide.” To put the severity of the condition into perspective, Dr. Chan further stated that, “Despite the best care available, in the U.S., 1 in 3 patients die from severe sepsis which is more than the number of people that die of heart attacks or single form of cancer.”
The U.S. and EU markets alone for MedaSorb’s medical device treatment, CytoSorb™, are huge, representing between $5 billion to $7 billion, with limited competition. The only direct competitor with an approved product is Eli Lilly, which markets Xigris™. Interestingly, while Xigris™ has proven to be a good product, it has had limited adoption due to its high cost, efficacy rates, timing of use, and potentially dangerous side effects.
Interestingly, much of the organ failure and mortality in severe sepsis is caused by the massive production of cytokines by the immune system, which clinicians refer to as a “cytokine storm”. CytoSorb™ is a cartridge used with standard dialysis equipment, that contain highly porous polymer beads designed to remove certain, harmful cytokines and treat this potentially fatal cytokine storm.
MedaSorb’s novel approach is not only a technological marvel, but the device has a 3 year shelf life, and can not only save hospital’s ICU resources, but has 3rd party reimbursement plans associated with its use.
The Company is currently conducting its European Sepsis Trial in Germany, which is the 3rd largest medical device market in the world. The trials randomized, controlled clinical trial are being conducted in 14 sites, using the CytoSorb™ device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Management pointed out that in recent weeks, recruitment has been accelerating. With the trials expected to end sometime later this year, if proven successful, MedaSorb will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. Thus, MedaSorb appears to be on the cusp of migrating from the R&D phase to the revenue generating stage.
During his discussion of MedaSorb’s history, Dr. Chan relayed an insightful story. As a partner in the NJTC Venture Fund, Dr. Chan led the Company’s Series B $5.25 million investment round. When it came time to name a successor to the outgoing President, Dr. Chan was elected to take over the Company. The Company raised $1.3M in late 2009 via warrant exercise by existing shareholders, including Dr.Chan, who is very excited about the MedaSorb’s prospects and present cash position, citing that. “We presently have a comfortable cash cushion” and may seek non-dilutive financing down the road.
In addition to treating severe sepsis, Dr. Chan believes that the CytoSorb™ device could potentially be used to treat other diseases and conditions and that the Company will develop a pipeline of proof of concept opportunities, including potential licensing candidates for the treatment of H1N1.
Since many infections such as severe sepsis, various forms of influenza such as H1N1, are the cycling of a cytokine storm as a body immune response, the use of the CytoSorb™ device could prove very effective. Management also believes that CytoSorb™ could one day be used as first line of defense against biological warfare such as anthrax or bubonic plague, as a treatment of the infection or pathogen triggered cytokine storm.
According to Dr. Chan, MedaSorb is currently weighing its options of signing up a strategic partner for potential European marketing of CytoSorb™, and it is possible that if the Company does not go it alone, that a strategic partner would be signed.
Dr. Chan noted, “If our technology works the way we hope it does, then it has the potential to be a blockbuster product. That can impact the top and bottom lines of most strategic partners. We believe we have a product that has little competition, a big market with unmet needs, technology attractive to strategic partners, and a solid, profitable business model.”
If MedaSorb meets its goals, it will not only be attractive to strategic partners, but to prospective shareholders as well.
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