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Andy, any thoughts on where we are regarding getting to 120 enrollees? Your post says to me we are in good shape when the data is analyzed. Opinions?
Cost-Effectiveness and Budget Impact of a Novel Antithrombotic Drug Removal System to Reduce Bleeding Risk in Patients on Preoperative Ticagrelor Undergoing Cardiac Surgery
Benjamin G Cohen et al. Am J Cardiovasc Drugs. 2023.
Hide details
Am J Cardiovasc Drugs
. 2023 May 19.
doi: 10.1007/s40256-023-00587-4. Online ahead of print.
Authors
Benjamin G Cohen 1 , Francine Chingcuanco 2 , Jingwei Zhang 3 , Natalie M Reid 2 , Victoria Lee 3 , Jonathan Hong 4 , Efthymios N Deliargyris 3 , William V Padula 5 6 7
Affiliations
1 Stage Analytics, Duluth, GA, USA. benjamin.cohen@stageanalytics.com.
2 Stage Analytics, Duluth, GA, USA.
3 CytoSorbents Corporation, Princeton, NJ, USA.
4 St. Boniface Hospital, University of Manitoba, Winnipeg, MB, Canada.
5 Stage Analytics, Duluth, GA, USA. padula@usc.edu.
6 Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, CA, USA. padula@usc.edu.
7 The Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, USC Schaeffer Center, 635 Downey Way (VPD), Los Angeles, CA, 90089, USA. padula@usc.edu.
PMID: 37204675
DOI: 10.1007/s40256-023-00587-4
Cite
Abstract
Background: Antithrombotic drugs, including the P2Y12 inhibitor ticagrelor, increase the risk of perioperative bleeding in patients requiring urgent cardiac surgery. Perioperative bleeding can lead to increased mortality and prolong intensive care unit and hospital stays. A novel sorbent-filled hemoperfusion cartridge that intraoperatively removes ticagrelor via hemoadsorption can reduce the risk of perioperative bleeding. We estimated the cost-effectiveness and budget impact of using this device versus standard practices to reduce the risk of perioperative bleeding during and after coronary artery bypass grafting from the US healthcare sector perspective.
Methods: We used a Markov model to analyze the cost-effectiveness and budget impact of the hemoadsorption device in three cohorts: (1) surgery within 1 day from last ticagrelor dose; (2) surgery between 1 and 2 days from last ticagrelor dose; and (3) a combined cohort. The model analyzed costs and quality-adjusted life years (QALYs). Results were interpreted as both incremental cost-effectiveness ratios and net monetary benefits (NMBs) at a cost-effectiveness threshold of $100,000/QALY. We analyzed parameter uncertainty using deterministic and probabilistic sensitivity analyses.
Results: The hemoadsorption device was dominant for each cohort. Patients with less than 1 day of washout in the device arm gained 0.017 QALYs at a savings of $1748 (USD), for an NMB of $3434. In patients with 1-2 days of washout, the device arm yielded 0.014 QALYs and a cost savings of $151, for an NMB of $1575. In the combined cohort, device gained 0.016 QALYs and a savings of $950 for an NMB of $2505. Per-member-per-month cost savings associated with device was estimated to be $0.02 for a one-million-member health plan.
Conclusion: This model found the hemoadsorption device to provide better clinical and economic outcomes compared with the standard of care in patients who required surgery within 2 days of ticagrelor discontinuation. Given the increasing use of ticagrelor in patients with acute coronary syndrome, incorporating this novel device may represent an important part of any bundle to save costs and reduce harm.
Talking to a buddy yesterday and he told me his friend's girlfriend needs major heart valve operation and that specifically the 3rd Covid vaccination has been causing all kinds of heart problem mayhem.
I only got the first two Covid vaccines thankfully !
He also told me that the Covid virus itself can also lead to these issues.
So gang, sit tight the real Covid related revenues could be just starting...
Now that is a very good sign. Hopefully more will do the same!
Bloch bought 10,000 shares at market price $31K.
15 years like a lot patience. Why do you think hecwukk get better at his job? He totally misread the outlook, did not raise money when could have and the clock and cash are ticking away.
JGR, you state "Chan blamed that on the factory's lack of ability to produce caused the lack of sales". I just don't recall that occurring. Can you post a link? It really doesn't seem like something he would state.
This is beyond remarkable. That she survived all of those medical emergencies, any of which could have taken her out, is simply amazing. How can our stock be sub $3? How?
Case of the Month
Literature Database
Use of CytoSorb for bilirubin removal in ischemic hepatitis and multiple organ failure due to uterine rupture with massive postpartum hemorrhage
Henry Kai Wing Chan, Kenny King Chung Chan | Department of Anesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China
05/03/2023
New!Other indicationsBilirubinCase of the Week / MonthCase reportCritical CareCRRT pre filterLiver failure
Download documentDownload document
Summary
CoM 05/2023 – This case reports on a 43-year-old pregnant woman, who was hospitalized for an anticipated complicated delivery.
Case presentation
The patient had hypothyroidism and was additionally on antihypertensive medication (methyldopa). She had also suffered from persistent liver impairment with hyperbilirubinemia from admission to hospital
Due to her medical condition, she was transferred to the Department of Anesthesia and Intensive Care for further management and induction of labor was performed at the 39-weeks gestation
Postpartum, the patient suddenly developed pulseless electrical activity (PEA) which resulted in a cardiac arrest for 20 minutes. An uterine rupture was noted and treated by emergency hysterectomy with embolization of the right internal iliac artery and ligation of left internal iliac artery. During the operation, the patient developed abdominal compartment syndrome with hypoxemia and so she was eventually connected to veno-venous extracorporeal membrane oxygenation (VV-ECMO) therapy
In addition to fluid substitution given her hypovolemic shock state high dose inotropic support was initiated
In the postoperative period, she required mass blood transfusions to manage her postpartum hemorrhage
Although the patient could eventually be weaned from ECMO, she developed signs of ischemic hepatitis accompanied by massive liver failure with serum bilirubin levels increasing to over 64 mg/dL on day 10 after ICU admission
Simultaneously, she developed acute renal failure, resulting in the initiation of continuous renal replacement therapy (CRRT)
Moreover, she was noted to be in atrial fibrillation with short pause intervals, followed by severe bradycardia (heart rate 40-50 bpm) and asystole for 2 minutes. Therefore, transvenous pacing (TVP) was inserted by the cardiologist for severe bradycardia
With the rationale to reduce her elevated bilirubin levels, a CytoSorb adsorber was integrated into the CRRT circuit
Treatment
A total of three treatment sessions of CytoSorb were run consecutively for a total of 52 hours
The CytoSorb absorber was installed pre-hemofilter into the CRRT circuit (AV1000S, multiFiltrate, Fresenius)
Blood flow rate: 80-100 ml/min
Measurements
Bilirubin serum levels
Results
CytoSorb treatment led to a reduction in serum bilirubin levels from 64 to 33 mg/dL within 12 hours of initialization. A slight rebound of bilirubin was observed and a second CytoSorb treatment was started. The patient’s serum bilirubin remained stable during CytoSorb treatment and continued to decrease over time
Patient Follow-Up
The patient was eventually weaned from TVP two days after discontinuation of CytoSorb treatment as her heart rate returned to normal sinus rhythm
Over time, her clinical condition further stabilized and liver as well as renal function progressively improved, both returning to normal values
She was discharged home four months later after a prolonged course of rehabilitation with her healthy baby
Conclusion
To the best of the authors knowledge, this is the first case that describes the use of CytoSorb for bilirubin removal in multiple organ failure, including cardiac arrest, ischemic hepatitis and renal failure following severe postpartum hemorrhage postpartum with uterine rupture
In this complex and multifactorial scenario, implementation of CytoSorb treatment successfully reduced the patient’s serum bilirubin level and was associated with improved liver and cardiac function, and eventually enabled weaning-off from transvenous pacing within a short time period
These data further support the use of hemoadsorption for bilirubin removal while treatment with CytoSorb was safe and feasible without technical problems.
Kathy had to leave the call to get to the bank. Sorry everyone.
Q1 2023 was $9.4 million...
CytoSorbents Reports First Quarter 2023 Results
May 2, 2023 - 4:15 pm
Pivotal U.S. and Canada STAR-T Trial enrollment enters the last third of the study. Strong customer demand from Q4 2022 continued into Q1 2023, with current expectation of overall sales growth in 2023
PRINCETON, N.J., May 02, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended March 31, 2023.
First Quarter 2023 Financial Results
Total revenue, including product sales and grant income, for Q1 2023 was $9.4 million, an increase of 9% compared to $8.7 million in Q1 2022
Q1 2023 product sales were $7.9 million versus $7.9 million in Q1 2022.
There were no COVID-related sales this quarter, compared to approximately $300K of COVID-related sales in Q1 2022
Currency effects negatively impacted Q1 2023 sales by approximately $349K. Constant currency core product sales in Q1 2023 were $8.3 million, an increase of $635K or 8.3%, over core products sales of $7.6 million in Q1 2022
Q1 2023 represents the second consecutive period of sequential quarterly product sales growth, and the first time that Q1 core product sales sequentially exceeded seasonally strong core Q4 sales in the past five years, which we believe represents a positive indicator of improving business
Q1 2023 product gross margin was approximately 68%, compared to 80% in Q1 2022 due to start-up activities of our new manufacturing facility
We believe the Company remains well-capitalized with cash and cash equivalents of $20.7 million (which includes $1.7 million in restricted cash) as of March 31, 2023
Recent Operating Highlights
We have now surpassed 200,000 cumulative human treatments globally after achieving 100,000 cumulative CytoSorb treatments in August 2020 less than 3 years ago. As of the end of Q1 2023, there have been more than 203,000 CytoSorb cumulative treatments delivered across more than 75 countries worldwide
The pivotal STAR-T randomized controlled trial achieved its second milestone of 80 patients enrolled on schedule in mid-April 2023, following the first milestone of 40 patients enrolled in November 2022, triggering a second pre-specified Data and Safety Monitoring Board (DSMB) review, which is expected to complete in the next few months. The trial continues to enroll well and is now in its last stage of enrollment, which is expected to complete this summer
Our Board Chairman, Al Kraus, announced his intent to retire at the end of his term in June 2023, following 20 years of leadership with the Company at age 78. He will continue to consult for the Company as needed. Pending the results of the 2023 Annual Meeting, current Board Director Michael Bator will succeed Al Kraus as Chairman of the Board
Highlighted a landmark publication in the high impact, peer-reviewed journal, Critical Care, underscoring the power of CytoSorb to reduce cytokine storm during systemic hyperinflammation caused by a very important toxin in half of sepsis cases, in a well-controlled, balanced, and definitive human study
Hosted a successful and highly attended scientific symposium and exhibition at the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) in Brussels, Belgium in March 2023, where data from the latest studies were presented and live-streamed, detailing the effect of CytoSorb in treating cytokine storm and deadly inflammation in diseases such as sepsis, shock, and acute respiratory distress syndrome (ARDS), including the study above which was the centerpiece of the session
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We believe we have started 2023 with favorable momentum and are pleased with the continued execution of three key goals described in the shareholder letter earlier this year.
1. Opening the U.S. and Canadian markets with DrugSorb®-ATR
The STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal, randomized controlled trial is designed to support U.S. FDA and Health Canada marketing approval of DrugSorb-ATR with the goal of demonstrating that DrugSorb-ATR reduces the risk of perioperative bleeding in patients undergoing cardiothoracic surgery on Brilinta® (ticagrelor, AstraZeneca). The STAR-T trial is enrolling well with recruitment by nearly all trial sites, both here in the U.S. and in Canada, and has recently outpaced our own internal projections. Should these trends continue, we expect to enroll the final third of the study this summer and have topline data by year-end that if positive, we believe would support the application for FDA and Health Canada marketing approval of DrugSorb-ATR.
As discussed recently, the rapid pace of enrollment of STAR-T led us to elect to forego a formal interim analysis on the first 80 patients. To fully understand this decision, it is important to clarify that the original intent of this interim analysis was to provide the opportunity to stop the trial early, an important option if enrollment was expected to be slow or delayed. However, the current enrollment pace is brisk and our projections suggest that the trial will likely be completed by the time a formal interim analysis - that requires fully monitored, cleaned, locked, and adjudicated data - would have been completed. Accordingly, a trial that is fully enrolled cannot be stopped early and as such we are now focusing our efforts on the final analysis. We believe it is also important to emphasize that there are no other considerations or information underlying this decision and that the STAR-T study data remain fully-blinded. The next milestone for the STAR-T trial is the second independent Data and Safety Monitoring Board (DSMB) safety evaluation after the first 80 patients which we expect to be completed in the next 2-3 months. As previously disclosed, the DSMB recommendation after the safety evaluation of the first 40 patients was to continue the study as planned without any modifications.
In parallel to the clinical study, Dr. Irina Kulinets, Senior Vice President of Global Regulatory, is leading the execution of the regulatory strategy for DrugSorb-ATR that at this stage includes strengthening her team, planning for future regulatory submissions, and driving interdepartmental alignment and responsibilities to meet our regulatory objectives and timelines.
Finally, we spoke previously of a pending proposal from Centers for Medicare & Medicaid Services (CMS) for Transitional Coverage of Emerging Technology (TCET) that could establish four years of U.S. Medicare coverage to breakthrough medical devices approved by the FDA. This proposal was expected in April 2023, and is still expected imminently. We believe that DrugSorb®-ATR, as an FDA Breakthrough Designated Device that targets many patients in the Medicare population undergoing open heart surgery and at high risk of unwanted bleeding due to blood thinners, could be well-suited for such a program.
2. Return to Sales Growth
We believe the achievement of sequential growth in Q1 2023 product sales from the prior quarter, and 8% quarterly core product sales growth year-over-year on a constant currency basis, represent an encouraging sign towards our goal of returning to sales growth this year. More important than this, however, is the general perception of our employees across each of our business segments of strong customer engagement, excellent feedback on our most recent clinical and scientific data across multiple indications in our therapeutic area verticals, and a trend of improvement in our hospital markets in core countries - though healthcare professional staffing remains a key issue. For example, in Germany, the DIVI Critical Care Society is reporting an increase in regularly operating adult intensive care units, and a concomitant sharp reduction in restricted ICUs – an important, non-quantitative assessment of the supply situation, which is governed by availability of staff, rooms, materials, and other factors. This has correlated with a major drop in COVID-related ICU admissions. If sustained, we believe it is likely that the mandate to have emergency reserve ICU beds for COVID-19 will also likely be lifted, freeing additional ICU capacity throughout the country. We expect this to translate into the ability to accept more non-COVID critically ill patients to the ICU and to do more surgical procedures, such as cardiac surgery, that require ICU postoperative care, which are all drivers of our business. Among our many growth initiatives, we are also seeing good progress in our strategy of expanding into German hospitals within private networks based on our preferred supplier agreements, increasing our accounts in these German networks by 50% last year over 2021.
https://www.stocktitan.net/news/CTSO/cyto-sorbents-reports-first-quarter-2023-qb8krwzat2t2.html
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Sorry that's one million two hundred thousand dollars a year!
Less than one tenth of that capacity of this factory was sold in 2022. Yet Chan blamed that on the factory's lack of ability to produce caused the lack of sales. This guy is making over one million two hundred dollars in salary and perks. Totally undeserved!! Been here over fifteen years hoping things would change. With this product we should be well above this price point. Total BAD leadership!
no "we" Harbor6460. I like that he has moved us from OTC to the Nasdaq, built a new production facility that can produce $400 million in product, got us to within a short period of time that we will have an expedited FDA approval, then restart the second one.
Chan we know is Worst CEO of all time. Imagine this product and we are still here 15 years later. Sad. And how about the amount of people that have died cause this product is not available.
I would like to ask Chan what 190 employees are doing!
Market seems to be worried that Chan will run out of cash before revenues pick up significantly. CFO Block had retired to a nifty consulting relationship and thus no liability.? Why no CFO to replace her? Have you noticed that press release -are often not posted on their website until hours or a day later? Poor IR effort .Chairman has resigned so he has no liability. No replacement. Chan getting rid of his detractors?Still paying lease on old facilities? What has happened to number of salesmen in Germany? Rough quarter?
CytoSorbents’ Pivotal STAR-T Trial Reaches Second Key Milestone With 80 Patients Enrolled
CytoSorbents
Thu, April 20, 2023 at 7:00 AM EDT
PRINCETON, N.J., April 20, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces that its pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial has enrolled 80 patients, achieving the second of three key enrollment milestones, and triggering a pre-specified Data and Safety Monitoring Board (DSMB) safety review.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased with the solid enrollment pace of the STAR-T trial, now two-thirds enrolled, and believe it reflects a) the positive enthusiasm and commitment of participating U.S. and Canadian study centers, b) the large unmet medical need and numbers of patients on ticagrelor undergoing cardiothoracic surgery, and c) the laser focus of our clinical team. We expect completion of the second DSMB safety review over the next several months.”
Dr. Deliargyris continued, “Because of the brisk enrollment of the trial, we continue to project that STAR-T will be fully enrolled this summer. Because of this, as we discussed in our last earnings call in March, we have elected to forego an interim analysis at this stage which would have otherwise taken several months to conclude, and instead race to complete trial enrollment on schedule and initiate the final study analysis, while preserving the full statistical power of the study. This would put us in the position of having top-line data later this year, with the goal of filing for U.S. FDA and Health Canada regulatory approval thereafter.”
The STAR-T trial intends to enroll approximately 120 patients at 30 centers in the U.S. and Canada to evaluate whether intraoperative use of DrugSorb®-ATR can reduce the high perioperative risk of bleeding in patients undergoing cardiothoracic surgery who have recently received the blood thinning agent, ticagrelor. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application, for which CytoSorbents received FDA Breakthrough Device Designation in April 2020, recognizing it as a major unmet medical need for which there are no FDA-approved or cleared therapies.
https://finance.yahoo.com/news/cytosorbents-pivotal-star-t-trial-110000273.html
I'm not an expert on this. That said, I am a heart patient on blood thinners. Here's my guess. There is no delay from the point of agreeing to be enrolled and the surgery. The whole point of the CTSO filter is to facilitate a quicker surgery when time is of the essence. These 80 couldn't wait. So, again my guess, all 80 already had surgery. The good news for us? The company has to know how this has been going AND I was buoyed by the positive comments in the cc. If the results haven't been good, they (Makis, Chan) certainly didn't let on. Again, not a doctor so all this is just an educated guess on my part. In 1993 I needed an emergency surgery and was given something to counteract my Coumadin. When the conversation goes like this "Take this and we can operate now. Or we can wait up to 5 days and you can die on any one of them". The choice is easy.
Thanks for sharing fantom. So how does this trial work? We wait for one of those of the 80 tacking a blood thinner to have a heart attack or heart complications, go back into the hospital and then (depending if not one of the placebo controlled) that patient gets treated with the cytosorbents filter during the the procedure/operation?
What a joke! What is she going to due consult Chan how to lose money which he has done for the last 15 years? Unbelievable!
Case of the Month
Use of CytoSorb in a case of hyperinflammation in the context of severe acute necrotizing pancreatitis
José O. Castro Abteilung für Intensivmedizin, Pacifica Salud Hospital, Panama-Stadt, Panama
04/04/2023
New!PancreatitisReduction in catecholaminesSafetyStandalone (HP)Improv. fluid balanceAnticoagulation HeparinCase of the Week / MonthCase reportCritical CareInflammatory parameters
Download documentDownload document
Summary
CoM 04/2023 – This case reports on a 34-year-old male patient with a history of heavy alcohol intake (1 bottle of wine per day for the past 15 years) but no other comorbidities, who was transferred to the emergency department due to an acute onset of epigastric abdominal pain, 24 h prior to admission.
Case presentation
Following initial physical and laboratory examinations, he was transferred to the general ward with severe pain and nausea, but without hemodynamic instability or respiratory failure
Over the next 48 hours, the patient showed progressive abdominal distention, tachypnea (36/min) and otherwise poor respiratory mechanics while already on a non-rebreather mask (15 L/min)
As a trial, high flow nasal cannula did not ameliorate his clinical picture, so he was finally intubated and mechanically ventilated. His hypoxemic respiratory failure was seen to be primarily attributed to volume overload due to aggressive fluid resuscitation (cumulative fluid-balance: 5 liters) as well as abdominal distention interfering with respiratory mechanics
After intravenous administration of furosemide and following initiation of positive pressure ventilation, a PaO2/FiO2 ratio >200 mmHg could be achieved
During his stay, the patient was extremely difficult to sedate, most probably due to high benzodiazepine tolerance and alcohol withdrawal
24 hours after intubation, a new onset of fever was noticed, accompanied by increasing vasopressor requirements and abdominal hypertension (intraabdominal pressure 16-18 mmHg)
Abdominal CT confirmed suspicion of pancreatic necrosis (around 80%) without any fluid collection, and bi-basal infiltrates (serum lipase on admission 1,718 U/L, amylase 389 U/L)
Moreover, methicillin-sensitive Staphylococcus aureus (MSSA) was isolated from his sputum and bacteremia with Streptococcus agalactiae was confirmed in the blood, resulting in the initiation of antibiotic therapy with meropenem
Despite antibiotic therapy and supportive care, his condition deteriorated further, with persistent fever, tachycardia (130/min), norepinephrine requirements up to 0.4 µg/kg/min, increasing leucocytes, C-reactive protein (CRPI 648 mg/l) and elevated procalcitonin (PCT) levels (4.2 ng/ml)
Given his worsening clinical condition and with the rationale to control the ongoing hyperinflammatory response, CytoSorb hemoadsorption was commenced in a stand-alone configuration (in the absence of renal failure)
Treatment
Two consecutive treatments with CytoSorb were performed for an overall treatment duration of 48 hours
CytoSorb was used in a stand-alone configuration (hemoperfusion mode) using a conventional dialysis machine (Aferetica)
Blood flow rate: 200 ml/min
Anticoagulation: 400-600 IU/h
Measurements
Hemodynamics and catecholamine requirements
Inflammatory response
Renal function
Cumulative fluid-balance
Results
Treatment resulted in an immediate improvement in his clinical condition. Within the first 6 hours of therapy, the dose of vasopressors could be reduced significantly (norepinephrine 0.1 µg/kg/min) accompanied by control of his hyperdynamic state (heart rate 95-100/min). He remained hemodynamically stable on low-dose vasopressor therapy over the following days. Norepinephrine administration was finally stopped on day 8 after admission
Additionally, there was control of the hyperinflammatory condition indicated by a clear reduction in inflammatory mediators (procalcitonin 2.69 ng/ml, CRP 559 mg/l) during the course of hemoadsorption therapy. This was accompanied by decreasing fever and an overall improvement in his clinical condition
Renal function remained normal throughout the entire period
The cumulative fluid balance (+7 liters at 48 hours) also decreased over time without any necessity for initiation of renal replacement therapy or ultrafiltration treatment
Patient Follow-Up
Following discontinuation of CytoSorb treatment, the patient remained on mechanical ventilation and medical management of the abdominal hypertension for 10 more days
In the follow-up period, the patient suffered an episode of severe acute respiratory distress syndrome (ARDS) in the context of ventilator-associated pneumonia, which was treated with prone positioning, steroids (dexamethasone) and intravenous antibiotics
Tracheostomy was performed and weaning from mechanical ventilation was started as well as adjustments to his nutrition and physical therapy
The patient was transferred to the normal ward after a total of 30 days
At the time of documentation, the patient is able to perform active exercises in the rehab center, is managing a low-fat diet by mouth with no assistance, requires only minimal oxygen support (nasal cannula 3L/min) and is planned for discharge in a stable clinical condition
Conclusion
In this patient with hyperinflammation in the context of severe acute necrotizing pancreatitis the use of CytoSorb led to hemodynamic stabilization and control of hyperinflammation
According to the authors, application of CytoSorb contributed to an overall reduction in morbidity and potentially rescued the patient from more severe long-term sequelae
In this case, CytoSorb was safe and easy to apply.
Landmark Publication Underscores Robust Ability of CytoSorb to Reduce Cytokine Storm during Systemic Hyperinflammation
March 29, 2023 08:30 ET | Source: CytoSorbents
"PRINCETON, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, highlights the recently published study entitled, “CytoSorb hemoperfusion markedly attenuates circulating cytokine concentrations during systemic inflammation in humans in vivo” in the renowned medical journal “Critical Care.” In this landmark publication, leading sepsis researchers in the group of Prof. Dr. Peter Pickkers from Radboud University Medical Center, Nijmegen, Netherlands convincingly demonstrate the robust ability of CytoSorb® to rapidly reduce cytokine storm during systemic hyperinflammation in a well-controlled and well-established human experimental sepsis model.
In this clinical study, Jensen, et al., intravenously administered bacterial lipopolysaccharide endotoxin - a dangerous toxin found on the surface of most Gram-negative bacteria such as E. coli, Pseudomonas, and Klebsiella - to twenty-four healthy male volunteers (age 18-35). Endotoxin is a common culprit in sepsis that potently activates the immune system, triggering the high production of cytokines, often called a “cytokine storm,” and severe inflammation. Extracorporeal blood purification with CytoSorb was then used to treat half of the volunteers for a total of 6 hours. Baseline demographic characteristics between those that received CytoSorb therapy and those that did not (control) were similar. All other interventions between the two groups were identical. Cytokine measurements were taken every hour or half-hour throughout the experiment.
Intravenous administration of endotoxin resulted in impressive transient increases in cytokine concentrations in the control group, characteristic of levels seen in a true cytokine storm. Meanwhile, the CytoSorb group had significantly lower plasma levels of cytokines, including TNF (median AUC: -58%, p<0.0001), IL-6 (-71%, p=0.003), IL-8 (-48%, p=0.02), IL-10 (-26%, p=0.03), MCP-1 (-34%, p=0.02) and MIP-1a (-39%, p=0.006), showing that CytoSorb profoundly attenuates the increase in circulating cytokine concentrations during endotoxin-induced systemic inflammation in humans. This result is very clinically relevant, as the severity and duration of cytokine storm and inflammation in sepsis are directly correlated with life-threatening complications such as shock, respiratory failure, and other organ failure, and the risk of death. Importantly, following endotoxin re-challenge seven days later (without blood purification), no differences in cytokine response were observed between the two groups, demonstrating that use of CytoSorb a week earlier did not affect long-term immune function.
Dr. Christian Steiner, Executive Vice President of Sales & Marketing of CytoSorbents, stated, “We are pleased to highlight this most recent publication from Professor Pickkers and colleagues, and were excited to invite Prof. Pickkers to speak on these results at our symposium at last week’s International Symposium on Intensive Care & Emergency Medicine in Brussels, Belgium. The response from current and prospective users has been extremely positive, and has helped to refocus our discussions on how to optimize the way CytoSorb is used to have the strongest effect, such as treating early, as seen in this study. We are very excited by this development and will continue to strive to make CytoSorb Therapy accessible to all patients in need.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The beauty of this study is its simplicity and elegance, demonstrating definitively that CytoSorb reduces cytokine storm in a well-controlled and balanced study that eliminates the heterogeneity and confounding variables that plague clinical trials in critically ill patients. This study corroborates the well-established literature on CytoSorb and cytokine reduction across many different fields over the past decade, and we strongly believe closes any debate on the utility of CytoSorb for this purpose. No other blood purification technology has amassed this level of evidence, helping to establish CytoSorb as the de facto standard for extracorporeal control of cytokine storm and hyperinflammation. Importantly, the use of CytoSorb for this purpose has been directly associated with positive clinical outcomes, such as high 74% survival in 100 critically ill COVID-19 patients when used with ECMO under FDA Emergency Use Authorization, as we reported from our U.S. CytoSorb Therapy in COVID-19 (CTC) Registry, or the reduction in sepsis-related mortality when used intraoperatively in patients with Staph. aureus endocarditis, for example. This is the heart of why CytoSorb has been used across 75 countries in more than 200,000 human treatments around the world to date.”
https://www.globenewswire.com/news-release/2023/03/29/2636667/25359/en/Landmark-Publication-Underscores-Robust-Ability-of-CytoSorb-to-Reduce-Cytokine-Storm-during-Systemic-Hyperinflammation.html
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Annoyed I forgot about this. Did anyone listen? Thx.
CytoSorbents Highlights New Clinical Data from Current Studies at the Live 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM)
March 22, 2023 08:09 ET | Source: CytoSorbents
PRINCETON, N.J., March 22, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced its scientific program for the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) Congress being held this week in Brussels, Belgium. Importantly, new data from some of the latest studies will be presented on Thursday, March 23, 2023, during a live streamed symposium entitled “Hemoadsorption with CytoSorb® – New evidence from current studies” from 12:30-1:30 PM CET (7:30-8:30AM EDT).
Session: “Hemoadsorption with CytoSorb® – New evidence from current studies”
Time: 12:30-1:30 PM CET (7:30-8:30AM EDT)
Place: Copper Hall, Brussels Congress Center
Registration: Live streamed webinar
https://www.globenewswire.com/news-release/2023/03/22/2632168/0/en/CytoSorbents-Highlights-New-Clinical-Data-from-Current-Studies-at-the-Live-42nd-International-Symposium-on-Intensive-Care-Emergency-Medicine-ISICEM.html
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Case of the Month
Use of CytoSorb in a patient with urosepsis and septic shock
Dr. Zsolt Rausch Department for Anesthesia, Surgical Intensive Care Medicine, Emergency Medicine and Pain Therapy, SLK Clinics Heilbronn, Heilbronn, Germany
03/01/2023
New!Reduction in catecholaminesSafetySeptic ShockAnticoagulation CitrateCase of the Week / MonthCase reportCRRT pre filterInflammatory parameters
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Summary
CoM 03/2023 – This case reports on a 56-year-old female patient who was admitted to hospital by ambulance with fever (up to 42°C) that had been persisting for 4 days, lower abdominal pain and progressive deterioration of her general condition.
Case presentation
Pre-existing medical conditions included morbid obesity (body mass index 46), arterial hypertension and chronic back pain
On admission, her vital signs were as follows: blood pressure 90/70 mmHg, tachycardia up to 180/min, SpO291%, respiratory rate 28/min and a Glasgow Coma Scale (GCS) score of 7
While still in the shock room, a FAST sonography, blood gas analysis and a CT from head to abdomen were performed. In addition, the patient was intubated and ventilated, and an arterial line inserted
The CT showed a grade II renal obstruction with an inflamed imbibed ureter on the right side as the only pathological findings
With the working diagnosis of urosepsis and septic shock, urine status and blood cultures were taken
Following admission to the intensive care unit (ICU), the patient was analgosedated (propofol, sufentanil), tachycardic up to 110/min with high catecholamine requirements
Advanced hemodynamic PiCCO monitoring was established. Septic shock was treated according to guidelines including volume resuscitation, catecholamine administration and initiation of empiric anti-infective therapy with piperacillin/tazobactam (for 5 days). After the detection of Klebsiella bacteria in blood cultures, urine and tracheal secretions, antibiotic therapy was changed to cefotaxime in accordance with the antibiogram
Over time, the patient’s right leg and left arm became cold following increasing doses of catecholamines and vasopressin (norepinephrine 0.67 µg/kg/min, argipressin 2.1 IU), accompanied by livid marbling of her toes and fingers. Consequently, administration of argipressin was stopped
Initially, urine was sterile and the focus of the infection not clear. However, a cerebrospinal fluid (CSF) puncture was performed to exclude meningitis in the presence of neck stiffness
Later that day, ultrasound-guided Shaldon catheter insertion was performed into the left internal jugular vein without any problems. Given the sepsis-associated hyperinflammatory picture and in order to stabilize the hemodynamic situation, renal replacement therapy in combination with CytoSorb hemoadsorption was started. At that time, the patient was anuric despite massive volume substitution
During the night of the second day, spasticity and a drop in blood pressure to 30 mmHg occurred during repositioning, most likely due to a leakage of the catecholamine line. After administration of epinephrine, she developed ventricular fibrillation, followed by 1x defibrillation and brief period of cardiopulmonary resuscitation (30 s) and return of spontaneous circulation. After subsequent administration of amiodarone 300 mg i.v., sinus rhythm was restored.
Treatment
CytoSorb treatment was started 14 hours after hospital admission and a total of 3 consecutive treatments with CytoSorb were performed over a period of 54 hours (change of the 1st adsorber after 12 hours, the 2nd and 3rdtreatment were performed for 27 and 18 hours, respectively)
CytoSorb was used in combination with CRRT (Fresenius, Mulitfiltrate CiCa) run in continuous veno-venous hemodialysis (CVVHD) mode
Blood flow rate: 170 ml/min, with a calculated blood purification volume of 6.12 L/kgBW*
Anticoagulation: citrate
CytoSorb adsorber position: pre-hemofilter
Measurements
Hemodynamics and need for vasoactive substances
Inflammatory parameters (interleukin 6, C-reactive protein, procalcitonin, leukocytes)
Lactate
Fluid balance
Renal function
Results
Following initially stable catecholamine requirements, vasoactive therapy with norepinephrine and vasopressin could be significantly reduced on the second day (from 0.67 µg/kg/min to 0.3 µg/kg/min) and both were completely discontinued on the fourth day. At the end of CytoSorb treatment (after 54 hours, on the third day), norepinephrine dosage was 0.05 µg/kg/min. Due to a recurring septic event (bilateral pneumonia), catecholamine requirements had to be increased again for a short time, but could be completely discontinued after 24 hours
The hyperinflammatory situation could also be well controlled during the use of CytoSorb therapy, as evidenced by a reduction in interleukin 6 levels from 344 to 66 pg/ml within 32 hours, with subsequently decreasing values thereafter. Plasma concentrations of procalcitonin and C-reactive protein also decreased significantly during and after hemoadsorption therapy. Leukocytes initially remained at normal levels during the course of CytoSorb therapy, rose progressively after the end, before spontaneously turning back to normal values in the following 2 weeks under appropriate therapy
Lactate levels significantly decreased under volume resuscitation and CytoSorb therapy and were back within the normal range (4.6 vs 1.05 mmol/L) at cessation of hemoadsorption therapy after 54 hours
After stabilization of the hemodynamic situation and a cumulative positive fluid balance of 30 litres, consistent negative balancing could be achieved from day 6 onwards
Furthermore, combined treatment with CRRT and CytoSorb was associated with a significant improvement in renal function with good diuresis as of day 4
Patient Follow-Up
Tracheotomy was performed 12 days after admission given the ongoing need for invasive ventilation and difficult weaning (morbid obesity, bilateral pneumonia and massive positive fluid balance)
The patient was successfully weaned off ventilation and decannulation was performed 21 days after her initial admission
Sonography confirmed that the right kidney was no longer congested and according to the urological consultation, urological intervention was not necessary at this time
The patient could be transferred to the normal ward after 24 days of intensive care in a good general clinical condition, awake, oriented, mobile and hemodynamically stable
The bladder catheter as well as the central venous cannula were removed due to the patient’s significantly improved laboratory results and favorable clinical condition
The patient was given physiotherapy for muscle weakness and fatigue, and after consultation with a neurologist, mild critical illness polyneuropathy and myopathy was diagnosed, and neurological rehabilitation was organized.
32 days after admission, the patient could finally be discharged from the hospital
Conclusions
In this patient with hyperinflammatory syndrome due to urosepsis with septic shock, combined treatment consisting of guideline-based sepsis therapy, CRRT and CytoSorb resulted in hemodynamic stabilization, control of the hyperinflammation and rapid recovery in renal function
According to the treating physicians, in this case CytoSorb therapy contributed to faster hemodynamic stabilization, shortened catecholamine therapy and faster improvement of renal function
Application of CytoSorb in combination with CRRT was safe and easy to perform
* Footnote
ABP = (CD × BF)/BW × 0,001
ABP = amount of blood purified (l/kg), CD = duration of treatment with CytoSorb® (min), BF = blood flow through the extra-corporeal circuit (ml/min) and BW = actual body weight (kg)
Reference: Schultz P, Schwier E, Eickmeyer C, Henzler D, Köhler T. High-dose CytoSorb hemoadsorption is associated with improved survival in patients with septic shock: A retrospective cohort study. J Crit Care. 2021 Aug;64:184-192.
Andy55q ,
How about a new case of the month?
HC Wainwright & Co. Reiterates Buy on CytoSorbents, Maintains $5.5 Price Target
by
richadhand@benzinga.com
March 10, 2023 6:25 AM
https://www.benzinga.com/news/23/03/31293044/hc-wainwright-co-reiterates-buy-on-cytosorbents-maintains-5-5-price-target
Positive trial news. That's the whole ballgame folks.
Next Quarter CC Headline "Steiner Cures Insomnia"
FYI 2022 Conf Call is tomorrow after market close :
CytoSorbents' management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q4 2022 and fiscal year ending December 31, 2022 followed by a question and answer session.
Conference Call Details:
Date: Thursday, March 9, 2023
Time: 4:30 PM Eastern
Participant Dial-In: 201-389-0879
Conference ID: 13736064
Live Presentation Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1596520&tp_key=3635996201
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link:
https://viavid.webcasts.com/starthere.jsp?ei=1596520&tp_key=3635996201
Good news. TD Cowen positive. Hurry up!
New European “Guidelines for the Management of Severe Perioperative Bleeding” Consider Hemoadsorption for the First-Time
CytoSorbents
Tue, March 7, 2023 at 7:00 AM EST
PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that hemoadsorption of antithrombotic drugs in cardiothoracic surgery has made its way into the new “2022 Guidelines for the Management of Severe Perioperative Bleeding” by the European Society of Anaesthesiology and Intensive Care (ESAIC) and was published in the European Journal of Anaesthesiology last week.
The aim of this second update to the guidelines previously published in 2017, was to provide an evidence-based set of recommendations to aid in the clinical management of patients at risk of surgical bleeding in a variety of clinical situations. The ESAIC Guideline Committee and Task Force worked with 20 expert affiliate co-authors to conduct a systematic literature search from 2015 – 2021, ultimately identifying approximately 138,000 articles that were assessed and, where appropriate, were used as new evidence to support the new guidelines.
In Section 2.1, “How Should Intra-operative and Postoperative Bleeding be Stopped and Anaemia be Managed” in patients undergoing cardiovascular surgery, the committee reviewed published studies using CytoSorb® to reduce bleeding complications in patients undergoing cardiac surgery on antithrombotic agents and made the following recommendation:
“In patients on ticagrelor or rivaroxaban undergoing emergency cardiac/aortic surgery on CPB [cardiopulmonary bypass], haemoadsorption may be considered as an adjuvant therapy to reduce bleeding complications.”
Dr. Christian Steiner, Executive VP Sales & Marketing of CytoSorbents, stated, “This is another step forward in helping to establish our blood purification technologies as the preferred way to prevent severe bleeding in patients on blood thinning medications undergoing cardiac surgery today, and potentially other surgeries in the future. CytoSorb® is already CE mark approved in the European Union to remove the blood thinners Brilinta®/Brilique® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Bayer, Janssen/Johnson & Johnson) during cardiothoracic surgery, and is being used for these indications in many hospitals throughout the world. We are excited that hemoadsorption of blood thinning medications has been considered in these updated European guidelines for the first time and that the concept is being highlighted to a broad and relevant audience.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The recognition of hemoadsorption of blood thinning drugs in these guidelines is a nice validation of our DrugSorb-ATR® clinical program in the U.S. and Canada. Should the ongoing STAR-T pivotal randomized controlled trial demonstrate that the DrugSorb-ATR system, which uses an equivalent polymer technology as CytoSorb, can safely reduce bleeding complications in cardiothoracic surgery patients on Brilinta®, we expect the data to not only support U.S. FDA and Health Canada marketing approval, but to also help establish our technologies as the standard of care therapy for this major unmet medical need in treatment guidelines worldwide.”
https://www.globenewswire.com/news-release/2023/03/07/2621884/25359/en/New-European-Guidelines-for-the-Management-of-Severe-Perioperative-Bleeding-Consider-Hemoadsorption-for-the-First-Time.html
https://finance.yahoo.com/news/european-guidelines-management-severe-perioperative-120000424.html
Did we access the other $10 million or didn't we? Why must we beg to get information from them?
Zacks Investment Research
scr.zacks.com
https://www.yahoo.com/now/ctso-initiation-established-medical-device-132000204.html
Source: CytoSorbents investor presentation
CytoSorbents Corporation (NASDAQ:CTSO) is U.S. based international medical device company
that has developed and marketed the CytoSorb® blood purification cartridge which is European
Union approved and sold in 75 countries worldwide.
The CytoSorb cartridge treats cytokine storms and massive uncontrolled inflammation in life-
threatening conditions such as sepsis, COVID-19, shock, lung failure, pancreatitis, and many other
applications.
The company is seeking U.S. FDA approvals for DrugSorb-ATR, an equivalent polymer technology
to CytoSorb, to reduce perioperative bleeding during cardiac surgery by removing blood thinners.
The pivotal STAR-T trial commenced in October 2021 to support FDA approval for this product and
enrollment of a third of the trial was reached in November 2022 and is expected to complete full
enrollment in the summer of 2023.
The company was awarded two FDA Breakthrough Device Designations for DrugSorb-ATR which is
often considered a “fast track” path for device approvals addressing major unmet clinical needs.
The company is currently marketing three approved products and has six more under development,
all of which are related to the company’s proprietary blood purification technology.
The company’s business model incorporates a “razor blade” business model in which the CytoSorb
device can be utilized across an installed base of blood pumps such as dialysis, CRRT, ECMO, and
heart-lung machines.
CytoSorb is led by an experience management team including CEO Phillip Chan and COO and
President Vincent Capponi who led the company through the E.U. approval and commercialization
of the CytoSorb device.
The company has approximately $23.8 million in cash on the balance sheet and $5.0 million in debt
as of 12/31/22. We believe the company has funds to support planned operations through at least
the 4th quarter of 2023.
The company uplisted to the NASDAQ in December 2013 and currently has a market capitalization
of approximately $142.0 million.
"We believe CTSO stock is worth $6.00 based on a conservative discounted cash flow (DCF)
calculation and a peer multiple comparison."
"This statement is being filed to report the fact that as of the date hereof the reporting person has become the beneficial owner of more than 5 percent of the class of securities."
URL is on bottom of this post....
SEC Form SC 13G Cytosorbents Corp Filed by: Skylands Capital, LLC
February 7, 2023 2:28 PM
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 13G
Under the Securities Exchange Act of 1934
(Amendment No. )*
CytoSorbents Corporation
(Name of Issuer)
Common Stock
(Title of Class of Securities)
23283X206
(CUSIP Number)
December 31, 2022
(Date of Event Which Requires Filing of this Statement)
Check the appropriate box to designate the rule pursuant to which this Schedule is filed:
/x / Rule 13d-1(b)
/ / Rule 13d-1(c)
/ / Rule 13d-1(d)
*The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided in a prior cover page.
The information required in the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).
CUSIP NO. 23283X206 13G
1 NAMES OF REPORTING PERSONS.
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY).
Skylands Capital, LLC
20-0775613
2 CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)
(a)
(b)
3 SEC USE ONLY
4 CITIZENSHIP OR PLACE OF ORGANIZATION
Wisconsin
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH:
5 SOLE VOTING POWER
2,337,091
6 SHARED VOTING POWER
0
7 SOLE DISPOSITIVE POWER
2,542,091
8 SHARED DISPOSITIVE POWER
0
9 AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
2,542,091
10 CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)
11 PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
5.8%
12 TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
IA
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Form SC 13G Cytosorbents Corp Filed by: Skylands Capital, LLC
February 7, 2023 2:28 PM
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 13G
Under the Securities Exchange Act of 1934
(Amendment No. )*
CytoSorbents Corporation
(Name of Issuer)
Common Stock
(Title of Class of Securities)
23283X206
(CUSIP Number)
December 31, 2022
(Date of Event Which Requires Filing of this Statement)
Check the appropriate box to designate the rule pursuant to which this Schedule is filed:
/x / Rule 13d-1(b)
/ / Rule 13d-1(c)
/ / Rule 13d-1(d)
*The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided in a prior cover page.
The information required in the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).
CUSIP NO. 23283X206 13G
1 NAMES OF REPORTING PERSONS.
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY).
Skylands Capital, LLC
20-0775613
2 CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)
(a)
(b)
3 SEC USE ONLY
4 CITIZENSHIP OR PLACE OF ORGANIZATION
Wisconsin
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH:
5 SOLE VOTING POWER
2,337,091
6 SHARED VOTING POWER
0
7 SOLE DISPOSITIVE POWER
2,542,091
8 SHARED DISPOSITIVE POWER
0
9 AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
2,542,091
10 CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)
11 PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
5.8%
12 TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
IA
CUSIP NO. 23283X206 13G
ITEM 1 (a) NAME OF ISSUER
CytoSorbents Corporation
ITEM 1 (b) ADDRESS OF ISSUER’S PRINCIPAL EXECUTIVE OFFICES
305 College Road East
Princeton, NJ 08540
ITEM 2 (a) NAME OF PERSON FILING
Skylands Capital, LLC
ITEM 2 (b) ADDRESS OF PRINCIPAL OFFICE OR, IF NONE, RESIDENCE
1200 N Mayfair Rd, Suite 250
Milwaukee, WI 53226
ITEM 2 (c) CITIZENSHIP
Wisconsin Limited Liability Company
ITEM 2 (d) TITLE OF CLASS OF SECURITIES
Common stock
ITEM 2 (e) CUSIP NUMBER
23283X206
ITEM 3 THIS STATEMENT IS FILED PURSUANT TO PARAGRAPH 240.13d-1(b) AND
THE PERSON FILING IS:
(e) an investment advisor in accordance with paragraph 240.13d-1(b)(1)(ii)(E)
ITEM 4 OWNERSHIP:
ITEM 4 (a) AMOUNT BENEFICIALLY OWNED:
2,542,091
ITEM 4 (b) PERCENT OF CLASS:
5.8%
ITEM 4 (c) NUMBER OF SHARES AS TO WHICH THE PERSON HAS:
(i) SOLE POWER TO VOTE OR TO DIRECT THE VOTE
2,337,091
(ii) SHARED POWER TO VOTE OR TO DIRECT THE VOTE
0
(iii) SOLE POWER TO DISPOSE OR TO DIRECT THE DISPOSITION OF
2,542,091
(iv) SHARED POWER TO DISPOSE OR TO DIRECT THE DISPOSITION OF
0
ITEM 5 OWNERSHIP OF FIVE PERCENT OR LESS OF A CLASS:
This statement is being filed to report the fact that as of the date hereof the reporting person has become the beneficial owner of more than 5 percent of the class of securities.
CUSIP NO. 23283X206 13G
ITEM 6 OWNERSHIP OF MORE THAN FIVE PERCENT ON BEHALF OF ANOTHER PERSON:
N/A
ITEM 7 IDENTIFICATION AND CLASSIFICATION OF THE SUBSIDIARY WHICH ACQUIRED THE SECURITY BEING REPORTED ON BY THE PARENT HOLDING COMPANY:
N/A
ITEM 8 IDENTIFICATION AND CLASSIFICATION OF MEMBERS OF THE GROUP:
N/A
ITEM 9 NOTICE OF DISSOLUTION OF THE GROUP:
N/A
ITEM 10 CERTIFICATION:
By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were acquired in the ordinary course of business and were not acquired for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired in connection with or as a participant in any transaction having that purpose or effect.
SIGNATURE
After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth
in this statement is true, complete and correct.
February 6, 2023
Date
BY: Virginia E. Riesing
Signature
Vice President & Treasurer
Skylands Capital, LLC
https://www.streetinsider.com/dr/news.php?id=21175107
__________________
What's going on grumpy people? Has victory been snatched from the jaws of defeat? Nice action, but seems like we won't have trial results for quite a while?
Here's also a new Feb 2nd 2023 forcast report on Sepsis (purchase). I'll put url below.
Sepsis Diagnostics Market Size to Surpass USD 1582.23 Million by 2030 at 9.80% CAGR – Report by Market Research Future (MRFR)
Sepsis Diagnostics Market Trends and Insights By Technology (Molecular Diagnostics, Biomarkers, Immunoassays and others), Type of Product (Kits, Instruments, Blood Culture Media and others), End Users (Pathology Laboratories, Specialty Clinics, Hospitals, Diagnostic Centers and others), Competitive Market Growth, Size, Share and Forecast to 2030
February 02, 2023 09:00 ET
| Source: Market Research Future
New York, USA, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Sepsis Diagnostics Market Overview
According to a Comprehensive Research Report by Market Research Future (MRFR), “Sepsis Diagnostics Market Information By Technology, Type of Product, End Users And Region - Forecast till 2030", the market is expected to gain a market value of USD 1,582.23 million by 2030 at a CAGR of 9.80% over the forecast period of 2022-2030.
Market Synopsis
Sepsis is a potentially fatal condition resulting from the body's immune system attacking its own tissues in response to an infection. Organs perform badly and inappropriately when the body's infection-fighting mechanisms are activated. As a result of the body's immune system attacking its tissues in response to an infection, sepsis is potentially lethal. Organs perform badly and inappropriately when the body's infection-fighting mechanisms are activated. Sepsis can lead to septic shock. This unexpected drop in blood pressure can seriously harm organs and even result in death. The likelihood of survival is improved by receiving intravenous fluids and antibiotics as soon as feasible. With the creation and introduction of such sophisticated, fast testing, major industry participants would have profitable prospects to improve their market position. Over the forecast period, the rising approval process and the launch of technologically sophisticated diagnostic solutions are anticipated to be the key drivers of market expansion.
Nosocomial infections, sometimes called hospital-acquired infections or HAIs, are a major cause of morbidity and mortality worldwide. The most common hospital-acquired infections are urinary tract infections, bronchitis, and sepsis (HAIs). Due to the rising incidence of sepsis and the growing global geriatric population, sepsis diagnosis is anticipated to have considerable market expansion throughout the predicted period. Increased government support for sepsis-related research initiatives and an increase in the prevalence of infectious diseases are the main drivers fueling the market's expansion.
Get Free Sample PDF Brochure @ https://www.marketresearchfuture.com/sample_request/2110
https://www.globenewswire.com/news-release/2023/02/02/2600533/0/en/Sepsis-Diagnostics-Market-Size-to-Surpass-USD-1582-23-Million-by-2030-at-9-80-CAGR-Report-by-Market-Research-Future-MRFR.html
Single-use Hemoperfusion Device Market by Type, by Technology, by End User: Global Opportunity Analysis and Industry Forecast, 2023-2028
Published: Feb. 1, 2023 at 3:55 a.m. ET
The MarketWatch News Department was not involved in the creation of this content.
Feb 01, 2023 (The Expresswire) -- The “Single-use Hemoperfusion Device Market” report provides an in-depth analysis of the size of the global market. It also discusses market size and segmentation at the regional and national levels, market share and growth, the competitive environment, sales analysis, and the impacts of domestic and foreign market participants.
Along with assessments of opportunities, strategic market growth, product introductions, and technological improvements, the Single-use Hemoperfusion Device market study provides in-depth evaluations of price chain improvement, trade legislation, and recent changes. The research also examines, revenue, sales, pricing, profit margin, market risks, opportunities, entry barriers, challenges and market by types (Activated Carbon Adsorption, Resin Adsorption).
Get a Sample Copy of the Report at - https://www.industryresearch.co/enquiry/request-sample/21586880
Some of the key players are:
Baxter International
Asahi Kasei Corporation
Toray Medical
Jafron Biomedical
Kaneka Medix Corporation
CytoSorbents
Baihe Medical
Some of the key questions answered in this report:
What will the Single-use Hemoperfusion Device market growth rate during the forecast period?
Which are the key factors driving the Single-use Hemoperfusion Device market?
What was the size of the Single-use Hemoperfusion Device market by 2028?
Which region is expected to hold the highest market share in the Single-use Hemoperfusion Device market?
What trends, challenges and barriers will impact the development and sizing of the Global Single-use Hemoperfusion Device market?
What are the opportunities in the global Single-use Hemoperfusion Device Industry?
Market Segment by Type:
Activated Carbon Adsorption
Resin Adsorption
Market Segment by Applications:
Hospital
Clinic
Geographical regions include in this report are “North America, Europe, Africa, Asia Pacific region, South America, Middle east and South east Asia”
To Understand How Covid-19 Impact Is Covered in This Report - https://www.industryresearch.co/enquiry/request-covid19/21586880
Url:
https://www.marketwatch.com/press-release/single-use-hemoperfusion-device-market-by-type-by-technology-by-end-user-global-opportunity-analysis-and-industry-forecast-2023-2028-2023-02-01
CytoSorbents Issues Stockholder Letter and Reports Preliminary Fourth Quarter and Full Year 2022 Revenue
Tue, January 31, 2023 at 7:15 AM EST
Tue, January 31, 2023 at 7:15 AM EST
In this article:
Cumulative CytoSorb treatments surpassed 195,000. Q4 2022 product sales rebounded from Q3 2022 low. Adjusted for constant currency, Core non-COVID 2022 product sales were within 5% of that achieved in 2021 and greater than 30% increased from pre-pandemic 2019
PRINCETON, N.J., Jan. 31, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, issues a stockholder letter from its Chief Executive Officer, Dr. Phillip Chan, and announces preliminary unaudited fourth quarter 2022 and full year 2022 results ahead of filing its Form 10-K.
CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)
CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)
More
Preliminary Unaudited Full Year 2022 Results
Cumulative CytoSorb treatments delivered exceeded 195,000 at the end of 2022, up 20% from the end of 2021, and marking the 10th year of CytoSorb commercialization
Preliminary unaudited 2022 Total Revenue, which includes Product Sales and Grant Revenue, was approximately $34.7 million versus $43.2 million in 2021, and $24.9 million in pre-pandemic 2019
Overall preliminary unaudited 2022 Product Sales were approximately $29.4 million versus $40.1 million in 2021, which included $0.3 million and $6.3 million in COVID-19 related Product Sales, respectively, and versus $22.8 million in pre-pandemic 2019
2022 Core (non-COVID-19) Product Sales were approximately $29.1 million versus $33.8 million in 2021. This reflects an 11% drop in the average Euro to dollar exchange rate from 1.18 in 2021 to 1.05 in 2022. On a constant currency basis, Core Product Sales would have been approximately $32.2 million versus $33.8 million in 2021, a decrease of 4.6%
Solid cash balance at the end of 2022 of approximately $23.8 million
Preliminary Unaudited Q4 2022 Results
Q4 2022 Total Revenue was approximately $9.4 million versus $10.8 million in Q4 2021, and versus $7.4 million in pre-pandemic Q4 2019
Q4 2022 Product Sales were approximately $7.6 million, which rose 18% sequentially from $6.5 million in Q3 2022, but were lower than the $9.7 million in Q4 2021, which benefitted from $1.7 million in COVID-related sales. Pre-pandemic Q4 2019 Product Sales were $6.6 million.
Core (non-COVID-19) Product Sales in Q4 2022 were approximately $7.6 million, compared to approximately $8.0 million in Q4 2021. On a constant currency basis, core Q4 2022 product sales would have been $8.5 million, a 6% increase over $8.0 million in Q4 2021
CytoSorbents targets pivotal STAR-T trial completion this year, with massive U.S. & Canadian markets in its sights
The Company expects to report fully-audited financial results for Q4 2022 and full year 2022 on Thursday, March 9, 2023, with a conference call held at 4:30PM ET. Further details for the earnings call will be provided at a later date.
https://finance.yahoo.com/news/cytosorbents-issues-stockholder-letter-reports-121500605.html
Case of the Month
Literature Database
Use of CytoSorb in a patient with hyperinflammatory syndrome following extensive 3-vessel coronary surgery
Dr. Angelika Oblin | Department of Cardiology, Cardiological Intensive Care Unit, Floridsdorf Hospital, Vienna, Austria
02/01/2023
New!Post-OpReduction in catecholaminesSafetyImprov. fluid balanceAortic SurgeryAnticoagulation CitrateCardiac surgeryCase of the Week / MonthCase reportCritical CareCRRT pre filterInflammatory parameters
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Summary
CoM 02/2023 – This case reports on a 60-year-old male patient who presented to hospital for elective aortocoronary bypass surgery.
Case presentation
His extensive cardiac medical history included chronic ischemic (3-vessel) heart disease, post-aortocoronary bypass, post-endovascular aortic repair for abdominal aortic aneurysm, peripheral arterial occlusive disease with serial high-grade stenosis of the left femoral artery, cerebral arterial occlusive disease, left ventricular hypertrophy, arterial hypertension, post-nephrectomy left, chronic nicotine abuse and hyperlipidemia
The operation was initially performed without complications and included a triple LIMA and LAD, RIMA and CX and vein [brachial left] and RCA. Repeated administration of low doses of norepinephrine was required for hemodynamic stabilization. The intraoperative cumulative fluid balance was +7400 ml (8800 in, 1400 out)
On postoperative transfer to the intensive care unit (ICU), the patient was deeply sedated (Richmond Agitation Sedation Scale [RASS] -5) and hemodynamically stable with still only low catecholamine requirements
During the night, however, catecholamine requirement increased (norepinephrine >1 µg/kg/min, additional administration of vasopressin) with simultaneously increasing lactate values (3.7 mmol/l). Hydrocortisone therapy was also started
Continuous renal replacement therapy (CRRT) was initiated 18 hours after postoperative transfer to the ICU because of progressively increasing retention parameters and to compensate for the metabolic acidosis (pH 7.3)
Given the simultaneously increasing inflammatory parameters (leukocytes 13.6×10³/µl, C-reactive protein [CRP] 37.45 mg/dl, interleukin-6 [IL-6] 16,586 pg/ml) in the context of a hyperinflammatory post-cardiopulmonary bypass syndrome and with the aim to hemodynamically stabilize the patient, a CytoSorb hemoadsorber was additionally integrated into the CRRT circuit
Treatment
A total of 10 treatments with CytoSorb were performed over a period of 96 hours (change of adsorber every 8 hours on day 1, and every 12 hours thereafter)
CytoSorb was used in combination with CRRT (Fresenius, Mulitfiltrate CiCa) run in continuous veno-venous hemodialysis (CVVHD) mode
Blood flow rate: 100 ml/min
Anticoagulation: Citrate
Position of the CytoSorb adsorber: pre-hemofilter
Measurements
Hemodynamics and norepinephrine requirements
Inflammatory parameters (leukocytes, CRP, IL-6)
Lactate
Fluid balance
Renal function
Results
Initially, blood pressure values fluctuated and he exhibited intermittent tachycardia as well as slightly increasing norepinephrine values (as part of the attempt to reduce volume). Catecholamine therapy with norepinephrine and vasopressin could then be significantly reduced from the second day onwards while vasopressin was discontinued after only 48 hours. Norepinephrine dosage was 0.43 µg/kg/min (under generous volume administration) on postoperative day 3. On the 4th postoperative day, only a low maintenance dose of norepinephrine (0.1 µg/kg/min) was required, which could be discontinued over the following days
In addition, the hyperinflammatory situation was well controlled during treatment, as evidenced by a reduction in IL-6 plasma levels to 360 pg/ml within 48 hours and further decreases thereafter. Leukocytes and CRP initially remained at an elevated level, but progressively decreased over time
Lactate values also reached normal ranges on the 4th postoperative day
After stabilization of his hemodynamic condition and a cumulative positive fluid balance of 18 litres, continuous negative fluid balancing could be achieved from day 3 onwards
Furthermore, the combined treatment with CRRT and CytoSorb was associated with a significant improvement in renal function with good diuresis from day 5 onwards
Patient Follow-Up
Successful extubation on postoperative day 5, initially without problems. However, over time he became tachypneic and stressed. This was followed by the start of a non-invasive high-flow ventilation regime
Removal of pleural drains on postoperative day 6
Also, discontinuation of renal replacement therapy after 2 therapy cycles 6 days after surgery
Transfer of the patient with non-invasive O2 application to the general ward after a total of 12 days of intensive care
Conclusions
In this patient with profound cardiac history with hyperinflammatory syndrome secondary to extensive 3-vessel coronary surgery, the postoperative combined use of CRRT and CytoSorb resulted in hemodynamic stabilization, control of hyperinflammation, resolution of metabolic acidosis, improvement in renal function and the possibility of a negative fluid balance
According to the authors, CytoSorb therapy helped to rapidly reduce the inflammatory parameters and thus stabilize the hyperinflammatory situation in this complex case
In this challenging setting, application of CytoSorb in combination with CRRT was safe and easy.
FULLY AGREE but it does not seem as high a priority for current management.
Excellent that they got several government funding grants and support.
Their long term belief in sepsis market has been narrowed to several smaller markets.
NAE has the cash, existing distribution in plasma, hospitals and blood banks already. In an acquisition HAE would not need any of CTSO executives. I hope it leads to a stock acquisition in the $10-15 value range.
Hemodefend has huge potential. Military and civilian use.
Someone on other blog site suggested HAE shouid acquire CTSO for the HemoDefend opportunity.
CytoSorbents Appoints Irina B. Kulinets, PhD, as Senior Vice President of Global Regulatory Affairs
Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents' executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities
PRINCETON, N.J., January 17, 2022 — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs. Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others. She will serve as a member of CytoSorbents' executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.
Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc., a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices. She has also worked for major U.S. and international life science corporations such as Johnson & Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and BioSphere Medical. She has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices. Dr. Kulinets has also provided executive strategic and operational leadership to help launch new products in the U.S., E.U., China, Japan, and many other Asian and Latin American markets.
Dr. Kulinets also has extensive experience as a regulator and worked for TUV America, Product Service - Medical Division and was appointed as a third-party FDA Inspector and 510(k) reviewer on behalf of the FDA to review, assess and approve new technologies.
Dr. Kulinets stated, "I am excited to join CytoSorbents at such an important time in the Company's history as it nears the completion of the STAR-T pivotal trial, evaluating the ability of the DrugSorb®-ATR system to reduce the risk of perioperative bleeding in cardiothoracic surgery caused by the antithrombotic drug, Brilinta®. During my career I have led the regulatory approval of many cardiovascular and neurovascular medical devices. I believe the DrugSorb®-ATR system is a unique breakthrough therapy that can reduce bleeding complications in this setting and we will be working diligently to bring this product to help clinicians and patients as the Company's first commercialized product in the U.S. and Canada. Meanwhile, CytoSorbents has so many other compelling technologies, such as CytoSorb® and HemoDefend®-BGA. I look forward to leveraging my U.S. and international regulatory and clinical expertise to help rapidly advance these programs around the world."
Mr. Vincent Capponi remarked, "I am excited that Irina is joining the CytoSorbents team to lead Global Regulatory Affairs. She comes to us with a wealth of regulatory experience in medical devices, tissue products, and drugs and has received numerous FDA approvals. In addition to U.S. approvals, Irina has led international approvals in Europe, China, Japan, South Korea, Latin America, Australia, and Canada."
Mr. Capponi continued, "First and foremost, Irina's focus will be to help drive FDA marketing approval of DrugSorb-ATR for our initial indication of Brilinta® removal, currently under study in the STAR-T trial, and then later for direct oral anticoagulant (DOAC) removal under the STAR-D trial. Irina's regulatory experience with cardiovascular devices aligns well with this intended use. Meanwhile, her background will no doubt be useful in expanding the DrugSorb-ATR market to hospital-wide applications where preoperative removal of antithrombotics could be helpful, as before emergency orthopedic or neurologic surgeries. At the same time, Irina is well-suited to help refine our global regulatory strategy for CytoSorb, HemoDefend-BGA (universal plasma), and other technologies currently under development. We are fortunate to have a regulatory professional of Irina's caliber to join our team and look forward to her future success."
Dr. Kulinets holds an M.S. in Mechanical Engineering from Belarus Polytechnic Academy, M.S. in Quality Systems from California State University, and a Ph.D. in Health Science from Trident University. She is RAPS (Regulatory Affairs Professionals Society) certified RAC (Regulatory Affairs Certification) and Board Certified in Medical Affairs. Irina also has strong ties to Academia. She served as a Faculty Director and lecturer for the Master of Science in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in Regulatory Science and Clinical Research program in Georgetown University, Washington DC. She has authored or co-authored 3 books and has multiple peer-reviewed publications in areas of her expertise.
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