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again this nonsense with the manipulation ..... more likely to be due to the miserable and untrustworthy management .... let's be surprised by the next quarterly results
A propensity score matching analysis
... Furthermore, there was no significant difference in the relative change in C-reactive protein, lactate, or norepinephrine demand in either group and the in-hospital mortality was similar between groups (73.7%). This small, heterogenous study showed no difference in IL-6 reduction, hemodynamic stabilization, or mortality in patients with CytoSorbtreatment compared to a matched patient population.
Yeah ..... we think we are the best company in the world, but unfortunately we are too stupid to prove it !
"....conditional approval..." !!!
See #25.993 !
REMOVE-Results ?
- regarding REMOVE results, after this very current publication (publication date Feb.03.2021) from Switzerland, I am absolutely no longer sure
Hemoadsorption during Cardiopulmonary Bypass in Patients with Endocarditis Undergoing Valve Surgery
- ... maybe this is why the publication of the REMOVE results will be "postponed" and the head of studies and CTSO management is now desperately looking for any positive data in the results
COVID-use ?
- can it be used at all for Corona in Germany due to the new "Recommendations (= guidelines !) for inpatient therapy for patients with COVID-19" at the ICU?
(See point 7.1 "Hospitalized patients with COVID-19 should receive standard drug thromboembolism prophylaxis with low molecular weight heparin in the absence of contraindications. Fondaparinux can be used as an alternative.")
S3-guideline - recommendations for inpatient therapy for patients with COVID-19
Here is a current publication from India and it is about the use of the filter after a heart operation (bypass operation) with the following severe septic shock; these are the basics or investigations within the framework of the REMOVE study (the results of which should be published in Q1 2021):
CytoSorb in the management of severe septic shock after coronary artery bypass graft surgery
Just have a look at the APACHE II- and SOFA-score before and after treatment with the filter!
Hemoperfusion with CytoSorb as Adjuvant Therapy in Critically Ill Patients with SARS-CoV2 Pneumonia
Rampino T, Gregorini M, Perotti L, Ferrari F, Pattonieri EF, Grignano MA, Valente M, Garrone A, Islam T, Libetta C, , Albertini R, Bruno R, Belliato M Blood Purification 2020; epub
11/2020
pubmed - Online ahead of print
In this article the authors conducted an observational study on nine consecutive COVID-19 positive patients hospitalized in their COVID Intensive Care Unit. Five of the patients were treated with hemoperfusion (HP) using a CytoSorb adsorber. Due to the emergency overload it was impossible to deliver blood purification in the other four patients. All patients had severe pneumonia requiring continuous positive airway pressure. HP was started in all five patients 6–7 days after hospital admission. The treated patients (T) received 2 consecutive sessions of the CytoSorb adsorber. The results showed a better clinical course for these CytoSorb treated patients compared to the control patients (C). All five CytoSorb patients except 1 survived, and only 2 of them had to be intubated, while all control patients required intubation and unfortunately died. Lymphocytopenia worsened in the controls but not in CytoSorb treated patients. C-reactive protein decreased in both patients, but to a greater extent in the CytoSorb group. Interleukin (IL)-6, IL-8, and TNF-a decreased after CytoSorb, IL-10 did not change. Respiratory function remained stable and did not worsen in the CytoSorb group compared to the controls. As the authors note, this experience suggests a potential therapeutic role of adjuvant CytoSorb in the early course of COVID-19 pneumonia by improving respiratory function and lowering mortality. The authors are currently conducting a randomized clinical trial which is ongoing.
Cytokine Adsorption in Severe Acute Respiratory Failure Requiring Veno-Venous Extracorporeal Membrane Oxygenation.
Rieder M, Duerschmied D, Zahn T, Lang C, Benk C, Lother A, Biever P, Bode C, Wengenmayer T, Staudacher D, Supady A. ASAIO J 2020; epub
11/2020
pubmed - Online ahead of print
Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is a last resort treatment option for patients with acute respiratory failure (acute respiratory distress syndrome [ARDS]). This is a report of a single-center registry data from nine all-comers with severe ARDS predominately from infectious cause, treated with V-V ECMO and cytokine adsorption using the CytoSorb adsorber, compared with a control group of nine propensity score matched patients who had undergone V-V ECMO support without cytokine adsorption. Even though scores (SOFA – Severity of Organ Failure Assessment, RESERVE – Predicting Death for Severe ARDS on V-V ECMO) both predicted a higher mortality in the cytokine adsorption group, mortality was reduced in the CytoSorb plus V-V-ECMO group compared with V-V ECMO alone. In total, 5 patients in the CytoSorb plus V-V-ECMO group survived (55.6%), compared with 2 (22.2%) from the V-V- ECMO alone group. The need for fluid resuscitation and vasopressor support as well as lactate levels dropped significantly in the cytokine adsorption group within 72 hours, whereas vasopressor need and lactate levels did not decrease significantly in the control group. Therefore, the authors conclude that cytokine adsorption might be beneficial in patients with severe ARDS requiring V-V ECMO support by contributing to hemodynamic stabilization and, in turn impacting on survival.
E-ISICEM 2020: visit our virtual booth
cytosorb-therapy website
Ticagrelor and Rivaroxaban Elimination With CytoSorb Adsorber Before Urgent Off-Pump Coronary Bypass
Case of the week out of Munich; published May 11, 2020 in Ann Thorac Surg.
case of the week 34
At 6-month follow-up, the patient had good pump function, sinus rhythm, and no cardiac symptoms => The operation should have been in autumn or winter 2019 ! Before
european approval
Q2 2020 Presentation
Earnings-Presentation-8.4.20
EAP Update Dec. 2015
".....In this discussion, the FDA indicated that 28-day all-cause mortality would be the appropriate primary endpoint regarding CytoSorb and the treatment of sepsis. CDER noted that historically, in many other sepsis trials unrelated to CytoSorb, there has been a lack of utility or correlation in surrogate endpoints when predicting mortality improvement in sepsis outcomes....."
Conference Call 2020:
"....In the ticagrelor registration PLATO trial, 1584 patients underwent CABG surgery randomized between dose received either ticagrelor or its competitor called Plavix or also known as Clopidogrel, and those patience with life-threatening bleeding are shown in this diagram. Bleeding risk is high despite waiting up to seven days off the drug prior to surgery. So you can see that if patients need to go to emergency surgery right away after failing the Cath Lab and not being able to get a stent, their risk of serious major or fatal life threatening bleeding is up to 65% if they have to go to surgery that first day....."
These are the facts or the results of the Plato approval study !
Everyone involved, including the FDA, is aware that operations on patients taking blood thinners pose an enormous risk of bleeding.
Conference call 2020:
"...Now what this has all done is it has set the stage for potential expedited U.S. regulatory path given our FDA breakthrough designations here in the United States. As I mentioned before in April, the FDA granted breakthrough designation to CytoSorb to remove ticagrelor during cardiopulmonary bypass in emerging or urging cardiothoracic surgery,which highlights the unmet medical need recognized by the FDA, but also helps to facilitate the path towards potential U.S. FDA approval. We're now in the process of defining the regulatory paths for the therapy with the FDA, whether or not it's a 510(k) versus the de novo 510(k) or PMA. If a clinical trial is needed, competitors such as Portola, that was recently acquired by Alexion for $1.4 billion and Fabio [ph] that is a public company that is still in the clinical trial phase. They've established an FDA Precedent, that surrogate markers such as platelet aggregation of Factor Xa activity can be used as the primary endpoint for FDA approval and in the sub-study, in the paper coming out of St. Georg Asklepios Hospital in Hamburg, Germany, four out of five or 80% of patients treated with CytoSorb had a rise in the MEA or Multiple Electrode Aggregometry Assay that correlates with the restoration of platelets function giving us additional visibility that if we were to pursue a trial, that we could see benefits here as well...."
Chan's statements in the conference call are shameful for a CEO and shameful for every rational-thinking person and shareholder of Cytosorbents (I am are shareholder !).
At the end of the first quarter, cytosorbents had a massive order backlog of around $ 2.7 million, and then the corona epidemic really started.
At the beginning of April, the "Emergency Use Authorization for Use in Patients with COVID-19 Infection" was obtained in the USA, and after this approval, some hospital in other regions of the world should have canceled orders or no longer needed the filter.
The US approval and the grazing corona epidemic in particular should have led to significantly more demand. No hospital on this planet will cancel an order in such a situation!
This is Chan's statement.
"And so in fact some of those, some of that backlog we never had a chance to fulfill, because those devices were not needed at the end of the day."
Chan should just take his hat and let a capable man take over his position!
Hemo Defend contract
Now known news has only been published once in an official press release. This news has already be "inofficial" be published on July,22.
SEC 8-K filing on July,22
The placement of the capital increase, including the exercise of the over-allotment option, has also not yet been published in an official press release (only via SEC filing).
OK, one more time:
Which cardiac surgery has or has the filter been used so far, where the patient can freely choose the period (so it is not an emergency operation?). You are welcome to give specific examples here, I did that too !!
And we are talking about the previous users in the heart area, i.e. mainly the German clinics and not the US clinics, which so far have not been allowed to use the filter for heart operations.
I am aware of this and that's why I wrote it !! "...the filter is currently not used for stent placement..."
Apparently you have no idea what operations the filter is used for. We are not talking about any visits or presentations by patients to doctors or in hospitals, but rather urgent cardiac operations. These emergency operations cannot and have not been postponed, you are welcome to call Bad Oeynhausen and inquire contact details!
The term "elective cardiac surgery" alone is an impudence in this context, because in contrast to an operation that cannot be postponed, the elective intervention can be freely selected in time.
Which cardiac surgery has or has the filter been used so far, where the patient can freely choose the period (so it is not an emergency operation?). You are welcome to give specific examples here, I did that too !!
And nobody denied that the sales people had significantly fewer customer contacts and probably no new customers in the field of cardiac surgery could be won during this period from the end of March to the end of June!
The issue here is that according to CytoSorbents, the existing customers inquired or ordered significantly fewer filters in Q2 because, according to Cytosorbents, there should have been declines in elective heart surgery and this is nonsense!
Perhaps the german clinics have reduced their inventories and then there will be some catching up effects in Q3, but they definitely have not performed significantly fewer emergency heart operations (where the filter is used normaly).
The negative interpretation would be that there was no reduction in inventory and that there was simply significantly less demand; because e.g. some clinics were not convinced of the results.
"Elective surgeries were stopped for months!" => "...that more than offset decreases in elective cardiac surgeries..."
Sorry, but this is a completely idiotic statement and I absolutely do not believe this statement by the management. In Germany (e.g. Bad Oeynhausen) the filter is currently only used for serious heart operations (open heart surgery) and these serious heart operations cannot even be postponed for weeks or months due to corona (maybe some days but not for months). These serious heart operations are as follows:
- heart valve surgery
- bypass surgery (if the veins are blocked, then this is always an emergency and the doctors cannot simply postpone a necessary operation for days or weeks, because the patient is dead or has serious damage !)
- combination interventions on heart valves with bypass surgery
- heart transplants
- implants of artificial heart support systems
As far as I know, the filter is currently not used for stent placement (i.e. no open heart surgery). The board can explain to us exactly what an “elective cardiac surgery” mean and in which cases the filter has been used or is used always or frequently. Then everyone can make their own opinion about this statement.
Again, this seems to be one of those obscuse management excuses.
It is a big deal !
This is very important and especially important for the current use in other areas (COVID-19) in America. If there is an interruption in an official approval study due to safety concerns, doctors may have problems using this filter in other areas without concern. And if there are no security concerns after an intensive review, this is very important and absolutely a big deal. In terms of sales, this will of course have no effect in the next few months, but this "clearance certificate" is extremely important for the company and the product.
"... the newly updated version of guidelines...." !!!
placement confirmation
"On July 24, 2020, CytoSorbents Corporation, a Delaware corporation (the “Company”), completed its previously announced underwritten public offering (the “Offering”) made pursuant to the Underwriting Agreement, dated as of July 21, 2020, by and among Cowen and Company, LLC and SVB Leerink LLC, as representatives of the several underwriters named therein (the “Underwriters”). On July 22, 2020, the Underwriters notified the Company that they had exercised their option to purchase an additional 789,473 shares of common stock, $0.001 par value per share (the “Common Stock”) in full. After giving effect to the full exercise of the Underwriters’ option, the Company issued and sold an aggregate 6,052,631 shares of Common Stock in the Offering, pursuant to the Company’s existing shelf registration statement on Form S-3 (File No. 333-226372). The Company received gross proceeds of approximately $57.5 million, before deducting the underwriting discounts and commissions and fees and expenses payable by the Company in connection with the Offering. Cowen and SVB Leerink acted as joint book-running managers for the Offering. B. Riley FBR acted as co-manager for the Offering."
As expected, the capital increase including the over-allotment option was fully placed and this has now been announced by SEC-filling. The part I highlighted in bold is interesting and the over-allotment option was already on July 22nd. drawn and then you can actually only come to the conclusion that everything had already been clarified and agreed in advance and there was no risk of placement.
Just a quick reminder of the schedule:
- July, 20th. after the market closes publication of preliminary Q2 figures and announcement of a large 40 million capital increase without mentioning placement price (publication of blank prospectus)
- July, 22th. Announcement of the final conditions and increase to 50 million => notification of an expected closing on July 24th.
- directly on July 22nd the issuing banks are already pulling the over-allotment option over the additional approx. 790,000 shares !! (a prankster who thinks of an agreement here ... there are bigger investors behind it)
The Combined Use of Tocilizumab and Hemoadsorption (CytoSorb) in a Patient with SARS-COV-2-19-Associated Pneumonia: A Case Report
A Case Report
"...A 40-year-old man with an uneventful history was admitted to our ICU due to a severe respiratory failure caused by SARS-CoV-2 that was diagnosed from the pharyngeal swab...."
Conclusions
In our experience, the combined use of CytoSorb® and tocilizumab was followed by the rapid improvement of the gas exchange and CRX in a patient with SARS-COV-2-19 pneumonia. These variations were associated with a sharp decrease of CRP and IL-6 whose levels remained low even on the day after the end of the treatment. We suggest considering the use of the combined approach of CytoSorb® and tocilizumab in patients with SARS-COV-2-19-induced pneumonia, ARDS, and/or multiple organ dysfunction syndrome with elevated levels of CRP.
My question then again:
Who can give me a derivation for the cash balance of 35.1 million at the end of Q2 ?
End of Q1 = 26.4 Mio cash
+ sale of own shares in Q2 for 4.5 Mio
+ 1.1 Mio. New Jersey Business Tax funding
= 32 Mio
32 Mio against 35.1 Mio ?
Cashflow of 3.1 Mio in Q2 => never ever ?!
Maybe someone can help me here: who can give me a derivation for the cash balance of 35.1 million at the end of Q2 ?
End of Q1 = 26.4 Mio cash
+ sale of own shares in Q2 for 4.5 Mio
+ 1.1 Mio. New Jersey Business Tax funding
= 32 Mio
32 Mio against 35.1 Mio ?
Cashflow of 3.1 Mio in Q2 => never ever ?!
Sorry but you are distorting the statements and the statements of the management were relatively clear in some points:
1) Statements from V. Capponi (minute 36.40 to 38) at the general meeting June 2, 2020:
"ramped production to near capacity over an ~8 week period allowing backorders and ongoing orders to be addressed in a timely fashion...."
2) Q1-results publication:
"The Company entered April with its first ever sales order backlog of approximately $2.7 million, which orders are expected to be filled in Q2 2020"
3) Q1-results publication:
"For the first time, we are able to make CytoSorb commercially available to all U.S. hospitals, physicians, and patients, now with nearly 200 inquiries, 30 active hospital accounts, with CytoSorb either shipped or in use at half of these, and multiple reorders. In the U.S., in a very short period of time, there have been approximately 25 patients treated, quite a number who have been weaned off of extracorporeal membrane oxygenation (ECMO) or mechanical ventilation...... This demand was on top of the already strong results from our existing business, resulting in an exceptional quarter with our first backlog ever."
and so on and so on !!!
My sales expectations were about $ 15 million, which is significantly higher, and the figures that have now been published show once again that management's statements cannot be trusted and should be trusted in the future. Apparently Dr. Chan is quite overwhelmed with the communication and management of the company and not up to the demands of good management. It is really time that the management is exchanged and experienced and trustworthy people are used here!
If the management make statements in the last conference calls like "our production runs 24/7 near full capacity" and "backlog 2.7 million from Q1" and "stocking order Fresenius in Mexico etc." then you have to ask yourself how a product turnover of only 9.5 million can be shown and whether the whole statements "were only false pretenses". Since the numbers absolutely do not agree with the statements made and the numbers speak a clear language.
And if Cytosorbents in Q2 uses the share sale program with the free sale of shares on the stock exchange at the same time, then everything gets a rather negative "taste". At the end of Q1 you had cash of around $ 26.4 million in your hands and now you have as of June 30th. Cash of approximately 35.1 million reported. Assuming Q2 with the lower margin and higher sales was roughly at "cash break even level", then Cytosorbents sold treasury shares for sales of around $ 9 million.
And on top comes a feature with the exclusion of subscription rights. Basically, I am more of a big fan of capital increases without subscription rights, since shares can be placed here more quickly and easily, which means that costs are significantly lower. Good management also manages to place these shares quickly and on acceptable terms in consultation with the accompanying banks. In my opinion, acceptable terms means the share price or max. 10% to 15% below the price before publication of the capital increase; with our management, however, I am afraid that the banks will cut their mark again here and that the placement price will be significantly below the last prices. I hope for a placement price of around $ 10, but I fear a course between $ 8.50 and $ 9.
And if I then read this passage "The Company intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering.", then I can really just shake my head and have to deny management any expertise !!
If you want to listen and watch yesterday's recording of "CytoSorbents to Host Key Opinion Leader Call on the Use of CytoSorb Blood Purification to Remove Antithrombotic Medications in Patients at Risk of Bleeding", simply register briefly and then you can watch the 90 minutes incl. view and listen to questions and answers. Very interesting:
Registration to view the recording
Stupid is as stupid does.
Here is the video record of "Euro Elso 2020 Virtual ECMO Day". The comments of the doctor from New York (minut 12.10 to 20.45) are interesting (First Clinical Experience in the USA !!):
Euro Elso 2020 Virtual ECMO Day
I am completely at fantomphan. The board has now repeated several times that the production has been increased since mid-march and that the machines run around the clock 7 days a week. They are not yet running at full capacity but quite close. Therefore, any sales for Q2 below $ 12 million will need a lot of explanation and management should have really lost the last credibility.
The management has made so many mistakes and wrong decisions in recent years that it is finally time for them to deliver.
All communication about the dismissal of Dr. Mortensen and the miserable process of REFRESH II would normally have been enough to replace Dr. Chan.
The tactic of the past 5 years has always been to conjure up new areas of application whenever problems with studies or admission studies occur.
Hemoadsorption for blood purification — incomparability of clinically available procedures
Abstract
Background.
In the field of intensive care medicine, but also increasingly in cardiac surgery, the use of adsorptive blood purification technologies for the treatment of hyperinflammatory conditions is becoming progressively more important. In addition to the CytoSorb concept, which is more and more clinically accepted and currently the most frequently used method, other companies—particularly from China—have recently entered the market with similar concepts.
Objectives.
Given this, the aim of this article is to analyze the different aspects of the various hemoadsorption products offered on the market today and to take a critical look at the available evidence.
Methods.
Technical features, applicationspecific characteristics, and the existing evidence of the adsorption technologies CytoSorb® (CytoSorbentsTM Inc., Monmouth Junction, NJ, USA), Jafron® HA series (Jafron Biomedical Co., Guangdong, China), and Biosky® MG series (Biosun® Medical Technology Co., Foshan City, Guangdong Province, China) were analyzed. The purely substance- specificmethods for endotoxin elimination only (Toraymyxin®, Alteco®) were not considered.
Results.
A comprehensive analysis of these criteria reveals that there are considerable differences between the various available technologies in terms of materials used, adsorption characteristics, application, and available data on safety and clinical experience. Furthermore, it becomes clear that not only the efficacy of blood purification technologies should be considered in terms of an effect–price–performance ratio, but that in particular the safety of the individual technologies is of crucial importance.
Discussion.
Among the technologies analyzed, CytoSorb currently represents the most investigated and clinically established procedure. Furthermore, it should be noted that clinical results, but particularly safetyrelevant aspects, are not transferable between the products due to technically different procedures.
Hemoadsorption for blood purification
The new flyer for "Ticagrelor- and Rivaroxaban- Removel" is really great:
Flyer Ticagrelor- and Rivaroxaban- Removel
Somehow strange that Biocon publishes an ad-hoc regarding the granted EUA approval in India and that CytoSorbents does not publish any news regarding this EUA:
Biocon Biologics Receives DCGI Approval for Emergency Use of CytoSorb® to Treat Critical COVID-19 Patients
In this short article the authors describe the immense challenges intensive care units are facing with the recent coronavirus SARS-CoV-2 pandemic, with hypoxic lung failure, acute heart failure and cytokine storm being the major determinants of an often fatal outcome. Recently it has been suggested that patients be screened for the cytokine storm by monitoring elevated levels of interleukin (IL)-6, IL-8 and tumor necrosis factor, as well as for the secondary form of hemophagocytic lymphohistiocytosis (HLH) by calculating the H-score. Anti-inflammatory interventions with specifc antibodies (e.g. against the IL-6 receptor), are currently evaluated, however, many aspects of the hyperinflammation caused by this novel disease are still unknown. To this end, the authors describe extracorporeal hemoadsorption, specifically CytoSorb, for COVID-19 associated cytokine storm syndrome. As they point out, CytoSorb has already been successfully used in various conditions with hyperinflammation including HLH. The authors state that there is also a reasonable chance that CytoSorb adsorbs the molecular motifs of the virus itself (pathogen associated molecular patterns) thereby limiting the cytokine storm rather than actively targeting individual pathways during inflammation. Finally, the authors consider it reasonable to employ hemoadsorption in selected COVID-19 patients with cytokine storm before prospective data is available, given the immense dynamics of disease, the pre-existing experiences in other conditions, and the devastating mortality of complicated cases.
EXTRACORPOREAL HEMOADSORPTION