This looks to us like it will translate in to a steady, modest growth trajectory, with no impending near-term milestone.
As for approval in the U.S., a small pilot trial is underway that is funded by the U.S. Air Force in trauma and rhabdomyolysis (muscle-crushing trauma). Although anecdotal results show that CytoSorb is saving lives in Europe, the company must do a trial in the U.S. before the FDA considers the product for approval. Importantly, the FDA has reviewed the safety date from the European trial and given CytoSorbents an investigational device exemption approval to conduct the Air Force trial. This application is one possible path to U.S. approval. The company also plans to commence a pivotal trial in sepsis, cardiac surgery or perhaps other indications by the end of this year that could lead to U.S. approval.
I project an organic ramp-up in growth as CytoSorbents expands its sales force, which is small now because it's a small company, with a $72M market cap. It appears as though CytoSorbents will achieve $1M in trailing 12-month sales in this quarter, with sales mainly in just three countries—Germany, Austria and the United Kingdom.
(PART 1): Quoted from his Life Science Report on March 6, 2014:
GZ: CytoSorbents is a small company, and is well off the radar of most analysts and investors. It has an interesting blood purification product called CytoSorb (a hemoperfusion device containing polymer beads in a cartridge installed inline with a dialysis machine or a cardiopulmonary bypass pump). The beads serve as a filter for a particular molecular weight range of proteins in the blood—in particular, CytoSorb filters out cytokines in critically ill patients who may suffer multiple organ failure if something is not done quickly. This cytokine storm, as it's called, is a response to serious bodily injury, such as infection, trauma or lung injury. CytoSorb is simple to use. You just put the cartridge in a blood dialysis or cardiopulmonary bypass circuit. Nothing special needs to be done to get it into the circuit, and once installed, it filters out cytokines. It has been approved for use in all 28 countries of the European Union (EU), and it is generating revenue there.
TLSR: Is it accurate to say that CytoSorb helps the critical-care physician stabilize the patient while dealing with the etiology of disease?
GZ: It does stabilize the patient, yes. It takes away a potent proinflammatory stimulus. In other words, it may save a patient's life while the physician deals with whatever caused the problem.
TLSR: CytoSorb is approved in Europe. What about the company's prospects for growth, and for approval in the U.S.?
GZ: Yes, it is CE-marked in the EU and available in other countries that recognize the CE mark, like Russia, India and Turkey. CytoSorbents is starting out with a small sales force, but it is in the process of building the force up to get the word out about the product, and inform physicians about successful case studies and a number of investigator-sponsored trials currently underway.
Agree. The Biocon deal was not even announced until April 8th. How much traction could they really get in one and a half months anyway? They essentially said on yesterday's call that very little premium was coming from India in Second Q. I expect some faster growth for next two quarters and we need to give these partnerships time to cultivate and grow.
Too many people were posting rediculous revenue pictures and somehow people were believing that they would be crushing the numbers by now. Didn't happen and we now just need to be cognizant that things do reuire patience and that all is on the right track.
I for one have a lot of shares and I was very happy with the tone of the entir call yesterday. BUY on dips.
Agree anything below $.26 at this point is a good buy.
Nice to FINALLY see them talking about it yesterday on CC (2 slides). They need to be shouting from the rooftops on he advantages on Cytosorb, and the ability to increase time for immune system to kill virus.
How about a PR on Ebola telling the world what you "next steps" are, not just those on CC!!!??
For those that actually listened to the CC, twice the Company clearly indicated that sales are dependent up geographical abnormalities. In the second quarter, Germany had 6 national holidays. These days of no sales had an effect on total sold. Not going to make much of an addition if they were not holidays, but a little explanation non the less.
I see your point. Agree totally that we should be hearing something from management. Extremely dissapointed.
It has no basis as a treatment direclty for the disease, but it could be a very prominent treatment for the cytokine storm that is associated with the back-end of the disease.
My question is whay are we not talking MORE about that?
The CEO should be out shouting from the rooftops about the effectiveness of our device for cytokine storm control.
LOL as he has to keep moving it up as the Ask and Bid keep going up!
The chart signals a reflection point. I like the coiled spring analogy. BUT, it still all comes down to execution and the Company needs to fulfill their previous exclamations for this to truly take off.
I am taking the calculated risk of anticipating this coiled spring momentum and have also bought in a very large amount of shares since the dip from $.20 after the $.25 offering. hard to believe we have not popped yet with the market peaking but I believe we may one day hit some furious uptick of which I will be standing by happily calculating my potentially significant gain.
Looking for $.50 and have a sell in for $.75 on a potential significant pop. Let's hope we continue the upward momentum!
I saw two large 50,000 share or above buys during the day. Slow rise from here until earnings. I am in at 423.25 and believe we are going up from here as well.
Agree!!!, But It's all relative! It is half of the average daily volume as of today, so it is a HUGE amount of share sin that respect. would love to see 2M shares traded today. Hopefully 333K shares is a drop in the bucket in 6 months!
$1.55 in cash and no debt makes it a possible target as well. Should hit $6.50 this week.