Cytosorbents (CTSO) shares have been on a roller coaster ride over the past year while moving from a relative unknown on the bulletin boards to becoming a commercial stage company with a potentially breakthrough product on the European market.

Surprising approval news in Europe - and I say surprising because few, if any, expected the European CE Mark approval to come before the trial was even finished - sent shares on a quick and clean triple before retracing their steps.

Shares then stabilized and consolidated when it became apparent that there was no quick road to immediate profits, rather the methodical commercial release would need to be accompanied by shareholder patience.

A couple of dips and bounces along the way, however, have offered up some decent trading opportunities, while the drop to the current levels in the mid teens might also have the long termers salivating at the buying opp.

The tale of the tape reads the same as it has for the past few months: this is going to be a volatile and exciting play until revenues ramp up to the point that the share price can stabilize behind guidance and expectations. Investors panic with every dip and expect the world with every spike, but as has been emphasized on numerous occasions, this is a patience play right now.

Check it out - Cytosorbents received a European approval for a product that fits a relative unmet medical and critical care need before the trial was complete.

That, in my view, is a sign of confidence.

With that approval, the company has been able to devise and put into motion a commercial launch, geared towards a slow roll-out in Germany before expanding to other regions. In other words, we're talking about a commercial stage company.

Additionally, news of the secondary endpoints results provided a worthy follow-up to go along with the solid primary endpoints that were met, and now that the results are out and the commercialization has commenced, it's time for the road show.

An announcement on Friday highlighted two key events that representatives of the company would be attending, AdvaMed 2011 MedTech Conference in Washington, D.C. on September 27, 2011, and then at the European Society of Intensive Care Medicine Congress in Berlin, Germany from October 2-5 in Berlin.

Dr. Phillip Chan, CEO of Cytosorbents, prepared this statement in advance of these events:

"Severe inflammation and cytokine-induced injury play a key role in many of the conditions targeted at the conference, including sepsis, acute respiratory distress syndrome, multiple organ failure, and trauma. Historically, however, therapies were not available to address these issues. CytoSorb™ is in a unique position to potentially fill this treatment gap, as a first-in-class cytokine filter that has demonstrated statistically significant reduction of cytokine storm in critically ill patients while improving patient outcome."

Highlight the comment about CytoSorb potentially filling the "gap."

There's no guarantee that a solid, new product is going to hit the market with a storm - even for those devices filling "gaps" in treatment as could CytoSorb - and that might have some investors squeamish since CTSO is a relatively small company that looks to be "going it alone."

That said, the methodical roll-out planned by the Cytosorbents staff is fit for a company of its size as it exposes less risk than an all-out commercialization blitz. The road shows will enable the company to 'spread the word', but the product also deserves a little bit of time to sell itself when put to use in live applications without investors worrying about the jockeying for a decent share price on a day to day basis.

We understand the impatience of the American investor, who wants to see his or her riches this evening, but good wine takes time to age to perfection, and if you believe that you've found that fine wine, then you'll have the patience to let it age until it's ripe to sip.

For a quick fix, you can always day trade some Grey Goose.

The general market stinks right now. A three hundred point gain in the DOW can be followed by a five hundred point drop. You can get dizzy trying to keep up, especially if you have been sipping on the Goose along the way.

If the volatility sets the panic in motion, then it might not be the time to dabble in stocks right now.

It's times like this where patience needs to be exercised and entry/exit strategies need to be observed.

As applied to CTSO, here's a company with a new product that might have no competition on the market that can do what CytoSorb does.

Are there non-believers still out there?

You bet.

You'll here about the small sample size and this and that, but the fact is this - CytoSorb is approved and it's all about seeing it work commercially now. The benefit is that any new treatment means new data. Probably not enough to convince the FDA to approve without another trial, but maybe enough to have the medical community in Europe become believers.

And that's all the company is shooting for right now.

The volatility is a sure certainty moving forward; CTSO is still a speculative play with no real revenue yet. But it's a lot less speculative than it was at this point last year, and if you play by the golden rule of investing - take some money off the table into any and all significant spikes - you should be way ahead of the game by now with an opportunity to reload in the mid teens.

There's no guarantees in this game, but I still like the Cytosorbents story, and it's only just still developing.


Disclosure: Long CTSO.

Add a Comment