CytoSorbents Corporation (CTSO)

[ping_pow_princess]

Fresenius is a Logical Partner

I noticed in the CTSO 10K, under Competition heading, two studies were not mentioned. They were mentioned in the Medwell Capital report. Gambro, Fresenius, and Cytosorbents are all currently conducting studies to remove middle molecular weight toxins in setting of sepsis. CTSO will be the first on the market.

I bring this up because Fresenius appears to be a logical partner for CTSO and appears they may have an interest in a technology that removes these middle weight toxins. Their trial for the Ultraflux EMiC2, Ultraflux AV1000S, was just completed last month. Theirs uses a Polysulfone membrane which removes "substances with a molecular weight of up to approximately 30,000 Dalton can be eliminated, but plasma proteins like albumin, bigger molecules and cellular blood constituents are retained".

The difference between the technologies: CTSO devices do not rely on membrane technology but instead use an adsorbent of specified pore size, which controls the size of the molecules which can pass into the adsorbent. I guess this contributes to its massive capacity which they state as one of their competitive advantage. Cytosorb target molecules up to 50,000 Daltons.

The past connection between Fresenius Medical Care and CTSO:

1) In 1999, we entered into an exclusive, long-term agreement with Fresenius Medical Care for the global marketing and distribution of our BetaSorb™ device and any similar product we may develop for the treatment of renal disease. We currently intend to pursue our BetaSorb™ product after the commercialization of the CytoSorb™ product. At such time as we determine to proceed with our proposed BetaSorb™ product, if ever, we will need to conduct additional clinical studies using the BetaSorb™ device to obtain European or FDA approval.

2)Dr. Edward Jones was as medical director of a dialysis facility for Fresenius Medical Care that sat on the board of directors.
http://findarticles.com/p/articles/mi_pwwi/is_200704/ai_n18800304/

Trials:

Gambro AB - Cascade Hemofiltration (60 patients)
http://clinicaltrials.gov/ct2/show/NCT00922870

Fresenius SE - Ultraflux EMiC2, Ultraflux AV1000S (24 patients)
http://clinicaltrials.gov/ct2/show/NCT01067313

Cytosorbents Cytosorb (100 patients)
http://clinicaltrials.gov/ct2/show/NCT00559130


10K – About the Cytosorb Technology

We believe that our products represent a unique approach to disease states and health complications associated with the presence of larger toxins (often referred to as middle molecular weight toxins) in the bloodstream, including sepsis, acute respiratory distress syndrome, trauma, severe burn injury, pancreatitis, post-operative complications of cardiac surgery (cardiopulmonary bypass surgery), damage to organs donated for transplant prior to organ harvest, and renal disease.

Researchers have explored the potential of using existing membrane-based dialysis technology to treat patients suffering from sepsis. These techniques are unable to effectively remove the middle molecular weight toxins. We believe that our devices may be able to remove middle molecular weight toxins from circulating blood.

CytoSorbents’ technology uses the same extra-corporeal circuits as dialysis, however, our devices do not rely on membrane technology but instead use an adsorbent of specified pore size, which controls the size of the molecules which can pass into the adsorbent. As blood flows over our polymer adsorbent, middle molecules such as cytokines flow into the polymer adsorbent and are adsorbed. Our devices do not use semipermeable membranes or dialysate. In addition, our devices do not remove fluids from the blood like a dialyzer. Accordingly, we believe that our technology has significant advantages as compared to traditional dialysis techniques.