is waiting for the inflection point
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What announcement?
I did a quick comparison against the previous presentation. Here are the changes I noted:
Obviously sales and treatment counts have been updated.
There is a new slide for CAR-T Cell.
New slide for organ transplant product, Perlife system, to launch by Aferetica this year.
Refresh 1 slide now points out “reduces pfHb by 35 - 40%”
Refresh 2 slide mentions 20-25 centers rather than 30-40. Projected timeline remains unchanged with start in Q4 2017 stated. I wish there was some actual news on progress with the FDA.
Still projecting Operating profitability in 2018
That dialog does read like a late night infomercial, but do you think a hack of an organization could generate 10 X normal volume? In my opinion it is probably more likely a leak of big news or simply an institutional investor(s) starting or increasing their position.
I am not familiar with them. If they really are a P&D group do you think they could generate the recent volume?
Wow. No doubt that is CTSO!
Psu, do you think this run up is going to end today?
BTW. Water intoxication is a real thing.
We live near the space center. There was a mandatory evacuation on the barrier islands, but with the move to the west I would guess 80 percent of my neighbors decided to stay. We are boarded up and sand bagged. I have my RV in front of my garage as a wind break. After the storm we can stay in it and enjoy the generator and AC if the house has no power. Tornados are about the only thing I am really concerned about right now.
Hey pears, did you evacuate? I am boarded up and sand bagged on the space coast.
It is not on the Cytosorb web site because it is a different product than Cytosorb. It is, however, on the Cytosorbents web site under technology and pipeline.
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor antagonist. The study that got it approved for CRS looked for a resolution of CRS within 14 days. “Thirty-one patients (69%; 95% CI: 53%–82%) achieved a response, defined as resolution of CRS within 14 days of the first dose of Actemra/RoActemra, no more than two doses of Actemra/RoActemra were needed, and no drugs other than Actemra/RoActemra and corticosteroids were used for treatment.”
If you follow the many case studies and studies of the week you will note that in most cases Cytosorb dramatically reduces IL-6 in a matter of hours not days. The Actemra study also had some of the patients on corticosteroids. Dr. Chan mentioned the following in the Q2 call “in many cases does not work and then they have to turn to high dose steroids, as it means that they exclude to shut off the immune response, but the problem with high steroids is that it can trigger apoptosis in the CAR T-cell immunotherapy therapy”. Do they really want to jeopardize the potential effectiveness of a treatment that costs $475k?
Cytosorb sounds like a much better rescue therapy than tocilizumab. However, tocilizumab is already approved in the US and Cytosorb is not. It should be interesting to see how things play out once Kymriah is available somewhere in the EU where Cytosorb is actually approved for use.
Good info, but I'm pretty sure the transcript incorrectly attributes this response to Dr. June. This response was actually from Dr. Chan. You can listen to the recording to verify.
The CNN article on the approval mentioned "The one-time treatment has a boxed warning for cytokine release syndrome or CRS".
I have read other CAR T-cell treatment articles that speculate the cost could be as high as 500k-750K. Sound crazy, but the same article pointed out that some chemotherapy treatments are around 625k per year.
A $1k Cytosorb cartridge might be good insurance for the $500K CAR T-Cell treatment.
He asked a simple math question based on number of issued shares and a fictitious market values. I simply answered it.
Approximately , 11 billion divided by 30 million would be around $366 per share.
I'm at 4.73. Some 8 cent shares in the mix.
The article is fishy. Her only having 2 articles is fishy. The trading this morning is fishy and likely an intentional coordinated effort by some party to pick up some shares before Monday. Let's see what Monday brings.
Also, if she is an Oxford Educated Biochemist, I am the Pope.
Wow. She lost all credibility with me with the assertion that sepsis may be a "disappearing" market only to then give credibility to a vitamin treatment for sepsis! Try searching: "A vitamin C cure for sepsis? Don’t hold your breath".
CTSO has the backing of Fresenius, Biocon and Terumo who have certainly done their own thorough Due Diligence before partnering. Also note that an early adopter in Germany already exceeded 1000 annual treatments in 2016 with other hospitals approaching that same milestone. If they were not seeing good result, do you really think we would see numbers that large?
A year ago I would have said there is no way they could get approval, but after the Sarepta approval last year, who knows what could happen.
I agree. He was doomed to a short life, but chemotherapy bought him 10 years. Without the infection it could have bought him a few more.
ectomesenchymoma. It was the infection from the port not that cancer that took him out.
A long time coworker lost her teenage son yesterday morning after a decade long battle with brain cancer. He had gone through many cycles of chemotherapy over the years. This time an infection from his chemotherapy port spread. I can't help but wonder if the outcome could have been much different if Cytosorb therapy was an option.
This is not a sepsis board. Also, Spectral’s product isn’t even specifically a sepsis treatment. It removes a potential sepsis trigger. That is endotoxins that are found on the outer membrane of gram-negative bacteria. These endotoxins can trigger an immune response leading to Sepsis. Once full blown sepsis has set in Spectral’s product can do very little to help the patient.
Cytosorb IS a sepsis treatment, but it is also much more. Cytosorb eliminates elevated cytokines associated with severe sepsis, septic shock, trauma, rhabdomyolysis, pancreatitis, lung injury, liver and kidney transplantation, liver failure, influenza, cardiac surgery, post-operative inflammation, toxic shock syndrome, necrotizing fasciitis, CAR T-cell therapy and many others. Additionally, it reduces plasma free hemoglobin associated with cardiac surgery, bilirubin associated with liver dysfunction and myoglobin associated with Rhabdo.
Big positive news and a short squeeze sounds good to me.
Can you cite any examples where post-hoc analysis directly lead to an FDA approval?
As for why Cytosorb might want a new generation device to also target endotoxins:
Sepsis is a run-away immune response. It is a cytokine storm, also known as cytokine cascade and hypercytokinemia, is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and white blood cells. Using a fire analogy, it is a conflagration that can result from a number of different ignition sources. One of the many is Gram negative bacteria, which has an outer membrane containing endotoxins. Endotoxins elicit strong immune response that can lead to sepsis. Spectral’s product targeted the removal of these endotoxins. So, it was targeting a very specific ignition source. The problem with that treatment approach is that sepsis/cytokine storm consists of “a positive feedback loop between cytokines and white blood cells.” That means once it hits a certain point the treatment of the initial ignition source is less critical than stopping the conflagration/cytokine storm that is now fueling itself. Spectral’s product could very well be effective at removing endotoxins, but the window of treatment between when the gram negative bacterial infection sets in and when the cytokine storm kicks in is probably very short and in the real word, the endotoxin removal treatment is not likely to be started within that window.
All that being said, the initial ignition source may be less critical, but it still needs to be addressed once the more critical cytokine storm is extinguished. That is where the need for Cytosorb XL come in to play. Like Cytosorb, it squashes the storm, but it also removes the endotoxins.
Wow. This statement is flat out false and I cited facts in an earlier post to back it up. Achieving the primary endpoint of IL-6 reduction with even fewer patients included in the analysis boosts the confidence in the results rather than reduces it.
So even with a smaller N, after excluding some patients, it proved effective in reduction of IL-6. That is not a failure. It was also enough for the CE mark.
Failure? The primary endpoint was IL-6 reduction.
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.
This is a very small company. In the march toward commercialization, obtaining funding in the early stages for large scale randomized, controlled FDA study would likely have been nearly impossible. At that time, even if they did, it would have been a risky all or nothing adventure.
Instead, they took an incremental EU route, using a small study to get Cytosorb broadly approved in the EU as cytokine adsorber. After approval they recruited KOL and earlier adopters to run IIT in addition to running their own dosing study in order to obtain further data supporting the safety and efficacy of the product. They also created an International Registry, which is registered as an observational study, in order to obtain further data supporting the safety and efficacy of the product. This collection of data and increasing use by early adopters in effect, fairly inexpensively, incrementally de-risked the product commercialization efforts by demonstrating efficacy and a market demand for the product by the physicians who have actually used in in the field.
They have stated many times that they can become a very successful company even without FDA approval, but of course FDA approval is obviously desired. So, with the EU sales starting to ramp up, profitability on the horizon, and completing recent funding efforts, they can now use the data collected in the EU treatments and their own phase 2 FDA cardiac study to help design an FDA pivotal study. They have also stated that a sepsis study in the US is planned eventually.
Bridge bank also likely got a peek at the expected Q2 numbers before closing this deal. Do you think they would have stated they were pleased with the performance is sales were down or the same as Q1?
My comments was meant add evidence to your claim that it does work.
Yes, a large scale study would be nice to be able to point to. The lack of clinical data is almost certainly a sticking point in getting new hospitals to try the device. But, I think one of the best signs of efficacy is that an early adopting hospital in Germany purchased over $1,000,000 in Cytosorb cartridges last year and there are other hospitals that should hit that mark soon. If they did not see positive results do you really think we would be seeing repurchasing at this level?
Spectral’s product and Cytosorb XL are very different devices.
Sepsis is a run-away immune response. It is a cytokine storm, also known as cytokine cascade and hypercytokinemia, is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and white blood cells. Using a fire analogy, it is a conflagration that can result from a number of different ignition sources. One of the many is Gram negative bacteria, which has an outer membrane containing endotoxins. Endotoxins elicit strong immune response that can lead to sepsis. Spectral’s product targeted the removal of these endotoxins. So, it was targeting a very specific ignition source. The problem with that treatment approach is that sepsis/cytokine storm consists of “a positive feedback loop between cytokines and white blood cells.” That means once it hits a certain point the treatment of the initial ignition source is less critical than stopping the conflagration/cytokine storm that is now fueling itself. Spectral’s product could very well be effective at removing endotoxins, but the window of treatment between when the gram negative bacterial infection sets in and when the cytokine storm kicks in is probably very short and in the real word, the endotoxin removal treatment is not likely to be started within that window.
All that being said, the initial ignition source may be less critical, but it still needs to be addressed once the more critical cytokine storm is extinguished. That is where the need for Cytosorb XL come in to play. Like Cytosorb, it squashes the storm, but it also removes the endotoxins.
For more details on endotoxins, sepsis and how short the viable window of an endotoxin removal treatment might be for sepsis, search for “brown.edu Sepsis Drug Fails To Help In Clinical Trial”.
BTW. Congrats on the new born. Alias I mean, of course.
I'm pretty sure margin calls are triggered by the amount of equity in the security compare to the maintenance margin. The last I looked, it's 25% with ctso. I don't think there's some magic $4 Margin Call trigger.
How long should it take for a tiny R&D biotech to build its own sales force and secure marketing partners to transition into a commercial medical device company?
In order to derisk cytosorb they took a path fiscally responsible for us shareholders. They did not launch a massive pivotal do or die US study, but instead chose the route of testing the waters with early adopters in Germany and a few other select countries to prove there is a market for the product. The investigators initiated studies and Cytosorb registry are the spark that should get sales burning. The company has said a few times recently that they consider the product derisked. That tells me that they are seeing, from the increasing sales to existing customers, that there is indeed and need and demand for the product.
BTW. CE mark happened in 2012, not in 2008 as your 9 year comment light suggest.
Hi Admins. Are there any controls in place to try to ensure that a user does not have multiple accounts, beside simply limiting one account per email address?
I did a quick scan of clinicaltrials dot gov for Car T-cell trials outside of the US where they might be able to Cytosorb if needed. Most of the studies were US based, but it looks like there are 4 in China.