Closer Look: CytoSorbents' surprise CE Mark approval Print
By Patrick Crutcher   
Friday, 01 April 2011 00:44
cytosorbentsShares of CytoSorbents Corp.(OTC: CTSO) soared on Thursday after the surprise announcement that their flagship product, CytoSorb, received European CE Mark approval.

We view this event as extremely positive for their future success; however, we are still hungry for the full results from their European Sepsis Trial. CE Mark approval certifies that CytoSorb™ has met the safety and label efficacy claim requirements of the European Medical Devices Directive and can now be sold in the European Union (E.U.). As we told readers on March 9th, we believed the device had significant potential to succeed in their EU trial.  

CytoSorb is a hemoperfusion device that utilizes highly porous polymer beads designed to remove certain proinflammatory and anti-inflammatory cytokines(eg. TNF-α, IL-1b, IL-10) from blood and physiologic fluids without reducing immune function. They are currently running a 100 patient study in the EU, data from which supported CE Mark approval. This was a randomized, placebo-controlled study comparing the standard of care(SOC) therapy versus SOC plus CytoSorb in the treatment of patients with severe infection and sepsis in the setting of acute respiratory distress syndrome(ARDS) or acute lung injury (ALI).

From the company's PR, "CytoSorb™ achieved its primary endpoint of IL-6 (interleukin-6) reduction with statistical significance based on an interim analysis of the trial. Interim data from this study demonstrated that CytoSorb™ plus standard of care therapy reduced IL-6 levels by an average of 49.1% (p = 0.01) during the CytoSorb™ treatment period compared to standard of care therapy alone."

Note that the secondary endpoints have yet to be announced; these endpoints will have a significant effect on the market potential for the device. Specifically, 28-day all cause mortality, Ventilator Free Days, and Multiple Organ Dysfunction Scores (MODS) will be very important secondary endpoints for the future success of their product. If CytoSorb can show a survival benefit in sepsis, that would be a very significant achievement.

Dr. Phillip Chan, Chief Executive Officer, stated, "Obtaining European regulatory approval for CytoSorb™ is the most significant accomplishment in our company's history and we thank our employees and our shareholders for their dedication and support. To our knowledge, we are the only device approved in the E.U. specifically as a cytokine filter, opening up many opportunities to not just treat patients with sepsis, but also patients with a host of life-threatening and non-life threatening inflammatory conditions where cytokine levels are elevated. As we analyze the clinical data from our current trial in sepsis, we look to continue to lead and foster additional clinical studies with a strong focus on sepsis and other critical care illnesses such as acute respiratory distress syndrome, severe burn injury, trauma, and pancreatitis, where the need is great and the human and financial costs are staggering. The goal is to drive broad usage of our technology and generate valuable clinical data across many fields."

Dr. Chan continued, "Now that we are permitted to manufacture CytoSorb™ devices for clinical use in the E.U. under CE Mark approval and ISO 13485 certification, we will ramp manufacturing for a controlled-market release in select territories in the second half of this year. The goal for 2011 is to build a solid foundation for future growth and responsibly make the transition from a development stage to a commercial stage medical device company. Our longer term goal is to pursue trials in the U.S. and attain FDA regulatory approval as well."

We have contacted management to get further commentary on this game-changing event for CytoSorbents. We are interested to talk about manufacturing capacity, initial sales projections, future clinical studies in the US and more. We look forward to hearing the full results from the EU Sepsis trial, since these will give a clear picture of CytoSorb's market potential.

See full press release here: CytoSorbents Corporation Achieves European Union Regulatory Approval for CytoSorb™

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