|Is CytoSorbents, Ready to Run?|
|By Vinny Cassano|
|Tuesday, 28 September 2010 00:28|
Shareholders of CytoSorbents Corporations (OTC BB: CTSO.OB) were greeted with pleasant news on Monday. The company has received an ISO 13485:2003 Full Quality Systems certification, a required milestone for medical devices to be considered for approval in Europe.
According to Monday's press release, ISO 13485 is an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (E.U.) and clears the way for gaining CE Mark approval for CytoSorb, a treatment for severe sepsis.
The CTSO share price traded up by roughly ten percent on the news, but more noticable was the signficant volume that this news attracting, working out to be nearly ten times the average trading volume.
The CytoSorb trial should be winding down at some point during the fourth quarter, and it's likely that we'll hear the results of the trial during the first few months of next year. Since a validated and effective treatment for severe sepsis has yet to materialize, CytoSorb could be a golden child for that market, if successful and approved in Europe.
Expect the company to roll into other countries - including the USA - shortly after an approval decision in Europe, and also expect a huge increase in price if the product is reported to have shown effective results in Phase III and especially if European approval follows.
Recent dilution has tempered expectations of the price spike potential, but a run to fifty cent should be a no-brainer on solid trial results, although I believe that CTSO could blow through the one dollar mark with ease if the buying demand is there. Over the longer term, the potential for growth is significantly higher.
Investors are still sceptical, I believe, and the stock may trade sideways for a while, but a cautious approach now by the big boys has opened the door for the small investor for the little guy to load up on shares that are going to look Crazy Eddie cheap if this product works out.
Keep it in the back of your mind, however, that there's nothing in the immediate pipeline for CytoSorbents to fall back on if this trial fails - all resources have been directed towards this trial - so it would be a prudent move to take some profits when possible just in case it doesn't work out.
The next six months should be full of excitements and developments for shareholders of CTSO.
Keep an eye on it.
Disclosure: Long CTSO.
Vinny also authors the popular stock investing blog VFC's Stock House.