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MONMOUTH JUNCTION, N.J., March 12, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, provided an update from its Chief Executive Officer, Dr. Phillip Chan, MD, PhD.
Dr. Phillip Chan stated, "As documented worldwide coronavirus cases surpass 125,000, we are witnessing a global escalation of activity to try to stem the tide of COVID-19 infection. The official World Health Organization (WHO) declaration of a formal pandemic, the lockdown on travel and non-essential businesses in Italy, and the U.S. ban on all travel from Europe, are just some examples. Coronavirus has also already begun to affect our own communities, with a shut down of schools, sporting events, conferences, and social gatherings. As testing in the U.S. becomes more available, the true extent of the spread of coronavirus will become clearer.
In discussions with physicians who are working in the epicenters of infection in Italy and China, the real problem with the COVID-19 pandemic is that serious and critically-ill patients are flooding hospitals, and overwhelming their ability to treat these patients. Intensive care units (ICU) are in gridlock and in many cases at the breaking point, as an increasing number of patients with life-threatening complications of COVID-19 infection such acute respiratory distress syndrome (ARDS), shock (i.e. a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections, occupy the limited number of ICU beds, and consume tremendous medical, equipment, and healthcare worker resources, with little hope of a quick recovery and ICU discharge.
The underlying cause for these complications is often a cytokine storm that results in a massive, systemic inflammatory response, leading to the damage of vital organs such as the lungs, heart, and kidneys, and ultimately multiple organ failure and death in many cases. Steroids are being used reflexively to try to control this inflammation, despite WHO recommendations against using steroids in COVID-19 infection, and evidence from other coronavirus infections (e.g. SARS and MERS) and influenza that its use can delay viral clearance and increase mortality.
This is why CytoSorb represents a potentially promising option in helping to treat these patients, and get them out of the ICU faster, thereby relieving this bottleneck. Although CytoSorb does not kill or remove the virus, it has been used in more than 80,000 treatments as an approved treatment of cytokine storm in the European Union and distributed in 58 countries around the world, where it has helped physicians control severe inflammation while helping to reverse shock, and improve respiratory and other organ function. And again, these complications are often the real reason patients die of COVID-19 infection.
Over the past two weeks, multiple patients with at least respiratory failure, shock, or kidney failure, in multiple hospitals in Wuhan, China have been treated with CytoSorb. Based on preliminary positive feedback on patient outcomes, we have responded to a request for additional devices and have now delivered a second shipment of CytoSorb devices to our partner in China, intended for new critically-ill COVID-19 patients.
In addition, we have learned of the first initial treatments of CytoSorb on COVID-19 patients in intensive care units in Italy. Though challenging to get feedback on how these patients have done, due to the overwhelming workload of the treating physicians, we hope to have more information soon. Meanwhile, we have also received an additional order from Iran, another country where coronavirus infection has been rapidly spreading.
Oddly in Germany, where CytoSorb has the greatest potential for COVID-19 treatment experience, the cases of coronavirus infection have been relatively mild, with Germany reporting more than 1,600 cases and only 3 deaths (0.2% mortality). This is in stark contrast to the U.S. with 1,257 cases and 38 deaths (3.0% mortality), and France, with 2,281 cases and 48 deaths (2.1% mortality). That said, German Chancellor Angela Merkel has warned that 60-70% of the population may get infected. Unfortunately, the reality is that there will be many opportunities to build treatment experience with CytoSorb in COVID-19 infection, not just in Germany, but wherever we sell CytoSorb.
There has been much discussion about the development of vaccines and anti-viral drugs for COVID-19. Unfortunately, a vaccine is not expected to be available until 12-18 months from now, far too late to impact the pandemic today. We welcome and applaud efforts to rapidly develop and evaluate anti-viral drugs that have activity against COVID-19, as these have the ability to reduce the severity of illness and potentially reduce the likelihood of an infected patient transmitting the virus to others. CytoSorb would work in synergy with these medications. That said, vaccines and anti-virals are not the full answer, as they do not treat the deadly complications of COVID-19 infection, as highlighted above. Seasonal influenza is just one example of this. Vaccines and anti-viral medications are readily available and used for the prevention and treatment of influenza, yet this season according to the Centers for Disease Control and Prevention (CDC), influenza was responsible for an estimated 34 million infections in the U.S., with 350,000 hospitalizations, resulting in 20,000 deaths – most of which were due to the complications of influenza infection that are nearly identical to those in COVID-19 infection.
Given the asymptomatic spread of COVID-19, the current lack of a vaccine and anti-viral therapies, and the fact the world population has no specific immunity to COVID-19, this pandemic has the potential to be devastating, causing a significant loss of life globally. Our goal is to make physicians aware of CytoSorb as a potential treatment option to help treat patients suffering from these deadly complications of severe COVID-19 infection, with the goal of speeding recovery, reducing the burden on ICUs, and saving lives.
As a final disclaimer, we currently have a strong cash balance, and have no need to raise capital at this time."
CytoSorb is approved in the European Union and distributed in 58 countries around the world.
CytoSorb is not yet approved in the United States.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date.
How come we never hear about the U.K? insurance issues?
Obviously there aren’t any language issues
https://www.chalicemedical.com/products/cytosorb-usa/
Italy goes from lockdown to shutdown as shops and bars ordered to close https://www.cnbc.com/2020/03/12/italy-shops-bars-and-restaurants-ordered-to-close.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
I wish they would make the China story and potential usage with virus complications more prevalent on their website. Maybe even establish a 24 hour hotline for questions and support.
https://www.nytimes.com/aponline/2020/03/09/world/europe/ap-eu-virus-outbreak-germany.html
Yet another article on why so few deaths in Germany
Germany and other stats
https://www.worldometers.info/coronavirus/country/germany/
I don’t doubt it but it’s a global emergency so anything is possible.
Now is not the time to throw in the towel or waste energy on destructive thoughts.
I keep thinking of the question:
What can WE do to help?
I challenge everyone on this board to give some thought into that.
Do it for Bertha :)
I don’t doubt it but it’s a global emergency so anything is possible.
Not the time to throw in the towel.
I keep thinking of the question:
What can WE do to help?
Do it for Bertha :)
I get it. I have a big loss too.
Instead of using our energy to complain or drive each other nuts by looking at the stock price every five minutes, some of you,if you have the time, might want to use your energy to go on some of the medical sites, Twitter , Facebook etc. and let people know about Cytosorb. There are lots of discussions going on by both doctors and patients because many loved ones are in intensive care and not looking good. I’ve seen for example discussions on sepsis due to the virus. People are desperate.These discussions are going on globally. I wouldn’t make it sound like we have the known cure but this is something the doctor should be aware of that may be able to prolong or save lives due to the complications caused by the virus. Just a suggestion.
I’m not going to speculate what they want given it’s a national emergency. If approved, they need to get the machines and filters along with needed training into the hospitals before this thing passes. Not an easy task. I hope they are working on a plan to do that and not worrying about the stock price or shareholder accusations.
Hopefully they are working to get this approved in US. I wonder if there is anything we can do to help. I don’t think the low death rate in Germany has anything to do with the filters but I’ve all ready posted on that. I speculate that the company is having a hard time getting data out of China. I don’t buy into the conspiracy theories. Not always a big fan of Chan but this is not the time to shake up management. I hope the board is active in providing strategic direction.
Do we know if other company ( competitor) filters are being used on the virus in China? Chan danced around that question. Unlike others, I thought he was saying yes. Doesn’t one of our competitors have a decent market in Japan?
As a reminder, Chan said the following on the conference call:
Hi, this is Eric on for Josh, thanks for taking the question. Just looking at CytoSorb's use in China. Do you intend to report the outcomes associated with COVID-19 treatment in China on a case-by-case basis? We're just trying to think of how many cases can be reported when it's announced?
Phillip Chan
I think that the goal here is to create a sufficient number of patients to be able to make some type of assessment of the efficacy of therapy in those patients. I think what we've seen is that multiple patients are being treated at multiple hospitals. And so I think that, that's very helpful in terms of achieving that goal. There is a very strong interest in anything to do with coronavirus as a publication, given how it's now spreading to all corners of this of this globe. And China having the most experience with this, it's scientists there are researchers there are very motivated to get those studies published.
So our hope is that whatever comes of this evaluation, that those data are made available in a very timely fashion.
Back in January we were under 4 due to the SA article. All is not lost.
Everyone needs to remain calm. Please don’t go nuclear and contact IR or the company.
I hope those aren’t billable hours for IR or legal. I would be shocked if there was insider selling. I would also be surprised if they used the ATM right now. Please don’t waste their time. If we find an article or paper referencing Cytosorb that is different. If I was contacting them which I’m not, I would have asked if there is anything we can do to help or support them.
I think the run up was likely due to the virus and started before we thought. Will also be interesting to see the short sales. I know shorts have been piling into some of the other virus related stocks and bragging about their gains.
I’ve never seen a company disclose use of ATM in real time. They are required to disclose at least quarterly in certain filings.
Also, my understanding it that it is prohibited when the issuer is in possession of material nonpublic information. I would think that may reasonably apply right now.
BREAKING: Italy reports 977 new cases of coronavirus and 168 new deaths.
A total of 10,149 cases and 631 deaths.
Right. I wouldn’t pester him with emails. The world is not going to end tomorrow. I hope he is focusing on getting things accomplished and not setting up and doing other media interviews. As you can see with other stocks, those gains tend not to last. I’m in it for the long term. Thanks
I’m not convinced it’s the ATM but maybe you guys know something I don’t. A lot of stocks are acting strange, not just this one. It’s all based on supply and demand and not necessarily intrinsic value. I admit it does seem like someone has been liquidating. This could still bounce up pretty fast and stay there. I’ve seen it happen with other medical manufacturers.
We don’t want to be viewed as a one trick pony. I think everyone needs to calm down.
How germany is controlling the virus vs Italy
https://www.foxnews.com/health/germany-coronavirus-outbreak-no-deaths
Not new but still on the front page
https://www.nsmedicaldevices.com/
The last minute was awesome. Liz said I sure hope somebody is listening such as FDA or someone from Pence’s office. You can’t buy that publicity
See prior post
It was posted online on Fox
Website about 20 minutes ago
http://video.foxbusiness.com/v/6139921760001/
What a wild ride today. Crazy
I hope they post the FOX biz link
Two people have died of coronavirus in Germany — the first deaths in the country from the virus.
The deaths occurred Monday in the district of Heinsberg and the city of Essen, the health ministry of North Rhine-Westphalia
I spoke to a doctor from Germany today who thinks it’s the different types of medicine they are using over there for treatment and not Cytosorb, but who knows...
Good article about China. No mention of us. Posting FYI
https://www.nytimes.com/2020/03/04/health/coronavirus-china-aylward.html
And tonight:
China reports 40 new confirmed cases and 22 additional deaths as of Mar. 8, bringing the total number of cases in the mainland to 80,735 and the cumulative death toll to 3,119.
Following the discharge of most patients, 11 of the 14 makeshift hospitals in Wuhan that were built for treatment of the new coronavirus have closed, Chinese state broadcaster CCTV said.
Chan was asked on the conference call ( around 31 minute mark) whether he would release results in China on case by case basis as it comes in or wait until they have more data, he seemed to say the latter, but hope it would be soon given the number of hospitals using it. Just my translation. Listen to the call for the exact wording.
https://viavid.webcasts.com/viewer/event.jsp?ei=1284732&tp_key=9264cc64ad
Most of the cases are in Bavaria and Baden-Württemberg. Do we know if any of the hospitals there have historically been using Cytosorb?
JH website is pretty good for data by geography
https://www.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
Forgot to include this one:
https://berlinspectator.com/2020/03/08/coronavirus-in-germany-no-end-in-sight/
Some of the virus case reporting is pretty scary. You’re fine and then five minutes later you have 105° temperature, 30 minutes later you are in really bad shape and then 30 minutes later you are dead. I’m sure most of the cases are not that way. Are the practices including getting people tested different in Germany than in other countries? I got to think there will be lots of reported deaths in Germany soon.
https://www.reuters.com/article/us-health-coronavirus-germany-idUSKBN20U0G6
Is cytosorb really used throughout Germany?
Here is an article describing the localities impacted as of a few days ago.
https://www.thelocal.de/20200305/map-the-parts-of-germany-most-affected-by-coronavirus-outbreak
I prefer they take their time and compile as much data as possible before issuing a press release. It must be chaos in those hospitals. Let CTSO inform medical professionals in an appropriate manner. I hope we see more use in other countries such as Italy. The virus isn’t going any where. They don’t need to hype the stock through a PR every time something happens. Thai is a big turn off to me.
Wow! Great news.
Cytosorb-xl is 4-5 years out. Is that a change? I remember that was touted in a call around a year ago.
Timeline : CytoSorb-XL is in advanced pre-clinical development as a potential next generation polymer to CytoSorb. It is expected to follow a similar path to E.U. approval as CytoSorb, expected within 4-5 years.
I was hoping to learn more about the increased legal fees on patent expense but all they said was : ... This increase was due to an increase in legal fees of approximately $334,000 related to patent matters and certain corporate initiatives, an increase in employment agency fees of approximately $88,000 related to the hiring of senior level personnel, an increase in accounting and auditing fees of approximately $24,000 and an increase in consulting fees of approximately $14,000.
Page 47 in bold text as always:
We will require additional capital in the future to fund our operations
Not always accurate but SA has the following:
Andrew D'Silva
Yeah, I’ll get last part of that question, which is related to partnering with Pharma. AstraZeneca for example, at least while PhaseBio is still in clinical trial, actually, they have some sort of a connection together there from a partnership standpoint. But in the interim, I mean, they have a small window left to be able to recapitalize before generics start coming into the market. Just from where I'm standing, make a lot of sense for them to work with you to help with their adoption.
Phillip Chan
Well, I think that the goal of a lot of pharmaceutical manufacturers is to maximize the revenue opportunity further for their drugs, particularly ones that are very key to their pipeline. And so the ability to dominate a market or the potential to dominate a market should be very attractive and to be able to eliminate competitors from that market. So that's all I can say at this time.
I knew they would need cash and lots of folks criticized me for saying so.
I hope he cuts down on conferences. Given the number of conferences being cancelled due to virus, this shouldn’t be a problem.
“...advertising and conference attendance of approximately $863,000”.
I too hope we get some good data out of Germany. I hope they are using it although I would think they would know by now if they were.
I really hope our product turns out to be effective in helping these patients. The world. Plus use some good news.
NY family of four all test positive for coronavirus as state cases climb to 6 https://www.cnbc.com/2020/03/04/yeshiva-university-in-new-york-city-cancels-class-after-student-tests-positive-for-coronavirus.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
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