Dr. Phillip Chan, Chief Executive Officer, of CytoSorbents Corporation (OTCBB:CTSO) presented at the 12th Annual Healthcare Conference at the Rodman & Renshaw Global Investment Conferenceand on Tuesday afternoon and updated the investment community on its clinical program.
Among other things, the company has reached nearly 80% completion of its clinical trial being conducted in Germany for the treatment of severe sepsis. With over 600 human treatments, 250 of which were septic, and no serious device related affects Cytosorb appears to be effective. Additionally, Dr. Chan reiterated that he expects the pivotal trial to be completed in 2010 with CE Mark approval coming in early 2011. This of course would be a major inflection point for the company which would move from a development stage to a fully operational commercial company.
Partnership rumors have also begun to swirl as Dr. Chan discussed recent developments at several key investment conferences in August.
Of particular interest was the military’s interest in the company’s flagship device at the Advanced Technology Applications for Combat Casualty Care (ATACCC) and Force Health Protection Conference (FHP). Due to the fact that many GIs die from sepsis shock resulting from combat related injuries (infection, burn wounds, etc), Dr. Chan believes Cytosorb could be a life saving device for active soldiers overseas.
Dr. Chan also updated investors concerning the company’s production plans upon CE Mark approval. Germany, the third largest medical device market, would be their primary focus. Currently, the company is in discussions with several major distributors in Germany. With limited competition and enough production capacity to meet initial demand, Dr. Chan believes Cytosorb would have widespread acceptance and rapid penetration across Europe.
Once CE Mark approval is obtained, the company plans to begin a trial in the USA in 2011 in hopes of securing FDA approval. According to Dr. Chan, this trial would involve around 300-500 patients, cost between $8-12 million and would likely be funded by a strategic partner.
These two markets together represent a total of $10-$15 billion in annual spending. And with Cytosorb’s prestigious management team, unique approach, near term commercialization, 27 unique patents and highly profitable “razor/razorblade” business model, the company is set to take a major chunk of it.
In regards to shareholders, a number of key milestones are approaching which could impact shareholder value significantly. These include:
1. Successful completion of the pivotal European trial
2. Strategic partnership with big Pharma and possibly other third parties
3. CE Mark Approval
Together, these milestones could result in positive gains for shareholders of a company currently only valued at only $8.5 million.
Disclosure: Long CTSO
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