is waiting for the inflection point
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Thanks. Most likely bilirubin removal then. I could certainly see that application turn into high volume. It is only a matter of time until something hits the switch for exponential sales acceleration and with Cytosorb I think there are multiple buttons that could do that.
The January PR stated "Meanwhile, we are diligently pursuing additional catalysts, particularly new high volume applications for CytoSorb. This gives us visibility and confidence that accelerated growth is on the horizon this year and beyond."
I am dying to know what these high volume applications might be. I am thinking we may see Cytosorb use in the EU to treat CRS after CAR T-Cell therapy, but I just don't see that a qualifying as something that would be "high volume".
A while back it was mentioned that one hospital had it as SOC for rhabdo, but is rhabdo even that common of an issue?
How about treatment for patients stuck on the waiting list for organ transplant?
Does anyone else have a guess on what these applications may be?
Over 50 investigator-initiated trials. Refresh 1 in the books refresh 2 starting up. Multiple big-name partners, Biocon Fresenius, Etc. At least one Clinic where it is now standard of care for rhabdo. Let's also not forget the hospital that has purchased more than 1 million dollars worth of the device in a calendar year. By now that hospital is probably not alone in that category. $1000000 is 1000 treatments. Do you think that maybe they got to about 800 treatments and said damn this thing isn't working, but we have money to burn, let's keep buying it?
In Recent quarterly reports and presentations the company had been using the term de-risked. That means they have validation that the product works, they have validation there is a market for the device and they have the ability to turn this into a profitable company.
What are you talking about? There has been no US trial for treating sepsis with Cytosorb and Refresh 1 and Refresh 2 are both for cardiac surgery.
Are you thinking of the EU study that got them the CE mark? It's protocol was treatment for 6 hours/day for up to 7 days, I believe. That study was not powered to predict mortality.
The primary outcome measure of that study was: Relative IL-6 levels as a percent (%) of baseline will be lower in subjects receiving CytoSorb treatment in conjunction with the standard of care as compared to control subjects receiving only the standard of care for ARDS/ALI in the setting of sepsis.
From a PR on the study:
CytoSorbents had previously reported that the primary endpoint of the study had been achieved with an average IL-6 reduction of 49.1% (p = 0.01) across the 7-day treatment period. Analysis of other important cytokines demonstrated similar patterns of reduction including MCP-1 (-49.5%, p = 0.002), IL-1ra (-36.5%, p = 0.001) and IL-8 (-30.2%, 0.002) with additional cytokine analysis ongoing. These data further confirm the effectiveness of CytoSorb™ as a broad cytokine filter and its ability to reduce cytokine storm in patients with sepsis.
Age is one of the strongest predictors of death and is consistent with our own data showing that patients aged 65 years and older had a nearly 5-fold greater risk of death than younger patients. In these patients, CytoSorb™ treatment resulted in a statistically significant improvement in 14-day mortality (0% vs 36% control, p = 0.04, n = 21) with trends to benefit in 28-day mortality (40% vs 45% control), fewer mechanically ventilated patients at 28 days (60% vs 73% control), and improvements in MODS and APACHE 2 organ failure scores during treatment. These data suggest that 7 days of CytoSorb™ treatment is protective for up to 14 days in this elderly population and that longer treatment with CytoSorb™, beyond the 7-day treatment limitation of the trial, could yield even greater benefit to these patients.
As expected, there is also a good correlation between CytoSorb™ cytokine reduction and outcome in patients with highly elevated IL-6 levels (greater than or equal to 1,000 pg/mL) or IL-1ra (greater than or equal to 16,000 pg/mL) which are both known, independent predictors of mortality in sepsis. In these patients, CytoSorb™ treatment showed positive trends to benefit in 28-day all-cause mortality (0% vs 62.5% control, n = 14), fewer patients on mechanical ventilation at 28 days (33% vs 88% control), and fewer days in the ICU (23.8 vs 27.5 days control).
They conducted another dosing study after EU approval and that is where they started testing longer treatment duration, up to 24 hours. The small refractory septic shock study also took it a step further treating the moribund patients by swapping in new devices much earlier than 24 hours. The results of that study are pretty spectacular.
According to the medical team, the patient would not have survived without the use of CytoSorb
Taco Tuesday! With a large side of bead stock!
I sent her a message on Facebook, when that story was published 2 weeks ago, suggesting a follow up story on Cytosorb might be of interest.
Something big must be coming very soon. Some brave soul ponied up $18 today for some Feb $10 calls. : )
I'm pretty sure that level of open interest on the Feb calls has been there for a few months now. We now have less than three weeks for catalyst to hit. Unfortunately, ctso is notorious for missing even self-imposed deadlines. So, even if someone did have some inkling on something big happening it would be a big risk to cut it this close, in my opinion.
I have seen this stock walked down 10, even 20 percent in a matter of hours. If a group has that ability to control the price so easily and they are fairly confident there will be not materially significant news before 2/16 why not walk the price up around the $7.50 range for a while to help sell the calls with confidence that they can walk it back down when needed. There is no way to know for sure, but watching this CTSO trade for years it is obvious someone out there has the ability to move the price where they want it pretty easily.
I still think those Feb $7.5 call sellers just don't want to buy to cover/give up any shares. There are about 375,000 shares in play there right now. It doesn't take much volume to move the price of this stock, so that is why my guess is that CTSO will be under $7.5 at close on 2/16/2018. Sure, big news could could disrupt that, but we have seen price swings over the last few years over 10% in just the matter of a few hours, with no material news to justify it. A coordinated group effort could do that pretty easily with as little as 50k-75k shares in their control. I am not part of a group like that and I suspect that what is going on is not legal, but it is just part of the game I guess. I am just a small retail player. I have a core holding plus some trading shares. At $7.50 I am way up on my trading shares so I have covered calls on them.
I'm pretty sure you just have to be a physician at a hospital in a region where Cytosorb is available. I also suspect that some sites register that have yet to use the device just so they can receive the periodic data released from the registry.
This case study mentions one of the goals was to reduce myoglobin to prevent kidney failure. I'm pretty sure that in one of the Q calls, quite a while ago, it was mentioned that one particular hospital was using Cytosorb as SOC for Rhabdo to removes excessive myoglobin that can lead to kidney failure. I imagine the use in these cases is prior to organ failure when possible.
I don't know about my closing price estimate but my roller coaster statement is spot on. : )
Under $7.50 and those 4000+ call options are out of the money. Over $8 the success fee on the 5 million dollar loan is triggered.
Continued roller coaster with closing at $7.49 on February 16th.
So I was listening to some music videos on YouTube this morning and an advertisement started playing for a drug named KeyTruda. It is apparently an FDA approved form of immunotherapy known as checkpoint inhibition. As with most drug commercials there was a listing of potential side effects with the most serious being "your immune system attacking normal organs". A quick look at the web page for the drug repeated this warning prominently in many locations. Perhaps Cytosorb use as a rescue therapy may be more wide-spread than as previously mentioned for CAR T-Cell treatment.
From the Keytruda site:
KEYTRUDA is a type of immunotherapy that works by blocking the PD-1 pathway and to help prevent cancer cells from hiding. KEYTRUDA helps the immune system do what it was meant to do: detect and fight cancer cells.
KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
So many things going on in this price range. Thousands of Feb $7.50 call options in play. Do the sellers or buyers have more ability to swing the share price? A success fee that the company must pay on the 5 million loan if they trade above $8 for more than 5 days. The burntoast guy citing $7.44 on the technical charts.
Then what is this talk of new high volume Cytosorb applications? EU CAR T-cell therapy support maybe? Something coming out of one of the DARPA or SBIR grants?
Did you contact Dr. Chan?
I have seen estimates of CAR T-cell therapy ranging from 470k to north of one million dollars. It has been mentioned that standard therapies to counter CRS can negate the effectiveness of CAR T-cell therapy. It seems like a no brainer to use a $1000 cartridge at the first sign of CRS to ensure the very very expensive cancer treatment is not wasted.
It sounds like researchers have determined that elevated cytokines(cytokine storm) creates an environment favorable for tumor growth. Circulating dead cancer cells can trigger elevated cytokines regardless of what killed the cells, be it chemo, radiation, etc. So the elevated cytokines increase the likelihood of the recurrence of cancer. They do not specifically call out CAR T-cell therapy, but from the studies it is apparent that the therapy frequently has the side effect of CRS(Cytokine Release Syndrome).
This stock is so easily manipulated with the low trading volume. Maybe run the price up close to 7 to bait folks into buying those Feb 7.50 calls, then beat the price back down to ensure they don't end up in the money.
I have them also.
As a fun exercise, take a peek at the posting history of a few of the most prolific negative posters here. Kinda interesting that they predominantly post to the same two message boards.
Just got the recording to work. Still saying this year for Refresh 2 start. Sounds like they must have submitted the IDE already if he still thinks things could come together in the next three weeks.
What was the line of Refresh 2? Start in 2017 or "next few months"?
I tried IE, Chrome and my cell phone. No luck with any of them.
LD Micro presentation. Has anyone been able to connect?
Bridge Back Success fee.
One of the triggers of the success fee is the stock trading over $8 for 5 days. They are also securing additional funding with the ATM sales. With these two factors in play, excluding a blast off and exponential rise in share price, isn't it in the companies best interest to keep the share prices as close to, but below, $8 as possible? If they trigger the success fee they will be on the hook to pay or dilute by $637K.
Speaking of the $8 share price. All those thousands of Feb $7.5 calls will also not make most of the buyers any money unless the prices is a bit over $8.
That is almost certainly a bot generated article where certain quarterly stats are used to select companies that meet some specific financial metrics and the company name and company specific metrics are plugged into the article text. There are absolutely no other facts about the company in the article.
2-3 years... I doubt that. This is another example of how long it can take to get a medical device through development and regulatory approval.
"In 2003, the project attracted its first NIH funding, and in 2012 the Food and Drug Administration selected the project for a fast-track approval program.
....
Pilot studies of the silicon filters could start in patients by the end of 2017."
So 14 years and no human studies yet. We complain about the slow progress of Cytosorbents, but is it really slow? They have 31,000 safe human treatment behind them along with a phase 2 FDA trial.
You would be hard pressed to find any long term investor that is happy with the companies issues setting expectations and meeting self imposed deadlines. While much slower than anyone would like, we do see them laying the groundwork to commercialize the product. We do see increasing sales. We do see progress towards the first pivotal US trial. We do see significant sales to early adopter hospitals, which validates potential future sales volume.
I believe that we have yet to see significant benefit from the time consuming groundwork that has taken place, but feel that it will help accelerate sales eventually. 15% QoQ sales increase is a good thing, but I am sure we are all still hoping for a breakout quarter to hit with a more exponential growth in sales. So, us long term investors stick around because we believe in the technology and we do see progress.
On the flip side, if someone does not believe in the technology of the "beads", does not believe regulatory and commercialization progress is being made and does not believe in management, then why would they waste hours upon hours monitoring and posting thousands of messages on and internet board? If one really has nothing but a negative sentiment about the company why waste so much time thinking about and posting about the company, rather than just moving on with life? Unless, that person has ulterior motives like I suggested or as swsmmss suggested, the person is simply unstable.
Anyone can say anything they want anonymously on an internet message board, so one must be cautious when evaluating the validity of the information presented by any poster. I have followed many biotechs over the last 2 decades. If I don't think a particular company is going to be successful, I move on, as most all reasonable investors do. If you see someone make thousands of negative posts, over a period of years, you can’t help but question the true motive of the poster. If they truly believed all the negative information they are presenting, they should have moved on long ago. The fact that they have not moved on can only lead one to assume they have an ulterior motive in their postings. Shorting, swing trading, who knows? It is perfectly within their rights to post whatever they want. However, when assessing the credibility of their negative posts just keep in mind that their motives are almost certainly for their own benefit which likely does not align with those investing in a company based on the merits and future outlook of the company.
Sales up about 15 %
CytoSorbents Recognized on Deloitte's 2017 Technology Fast 500™ as One of the Fastest Growing Companies in North America. Still saying REFRESH 2 will start this year and profitability in 2018.
Hmmm. I dind it somewhat odd that there have been a number of post deletions by the IH Admin, rather than the board Admins, with no obvious TOS violations.
I'm pretty sure this was the study that got them EU approval for IL-6 removal, started back in 2008. Note the max treatment duration of 6h/day for up to 7 days. Treatment for 6 hours and then allowing the cytokine storm to re-intesify for 18 hours was probably not the best treatment plan. However, at that time, they had no clinical data on human treatments, so they had to play it safe. They are using the device up to 24h/day now.
So they removed pig kidneys, kept them on ice for 22 hours then reperfused on a circuit or did they actually transplant them into a pig?
Of course institutional investors always immediately invest in a new company after listening to a 17 minute presentation and a conference. It would be absolutely ridiculous for them to do any additional Due Diligence first, right?
Do you think the hospital that hit the one .million dollar mark in annual Cytosorb purchases and the others nearing that milestone are seeing poor clinical result but are still using the device anyway?
BTW, those investigator initiated trials are funded by the investigator.