MedaSorb requested that we clarify a few of our assumptions. We previously mentioned that we were hopeful we would get a progress update on trials at the upcoming 2009 International Sepsis Forum in November because of the following statement from the CEO, Dr. Chan, in the interview conducted in July 2009 by CEOCFOinterviews.com: "We also plan to publish our results and present at major annual conferences such as the International Sepsis Forum and the Congress of the Society of Critical Care Medicine." MedaSorb has informed us that they will not be attending the conference this year and that the statement given in the interview was an example of venues where they may present results after the trials are complete.
We also assumed MedaSorb was nearing completion of their current clinical trials based on end of year target information we obtained from various recent press releases, but MedaSorb notified us that in their recent 10Q filed with the SEC in August 2009, they made cautionary statements related to this timing: "To date patient enrollment has been slower than originally anticipated. The Company has taken a number of steps to improve recruitment, the most significant of which is the increase in the number of our clinical trial sites. With more sites actively seeking to enroll patients, we expect the patient enrollment rate to increase going forward. Concurrent with the clinical study, we have commenced preparation for the CE Mark submission process. Management believes it will take up to an additional 3-6 months following its submission for CE Mark approval to receive European regulatory approval. Assuming an increase in patient recruitment, availability of adequate and timely funding, and a successful outcome of the study, we continue to expect to obtain CE Mark approval in 2010."
We are still extremely optimistic about the potential of MedaSorb Technologies and their current pipeline of medical devices. We look forward to hearing the results when the clinical trials are complete.
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SOURCE: TapeBeat.com
TapeBeat.com Philip Runfeldt, 800-856-8734 admin@tapebeat.com

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