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Extracorporeal hemoadsorption therapy as a potential therapeutic option for rapid removal of Apixaban in high risk-surgical patients: a case report
Case report Published: 07 July 2023
Vittorio Dalmastri, Andrea Angelini, …Gaetano La Manna Show authors
Journal of Medical Case Reports volume 17, Article number: 283 (2023) Cite this article
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Case report
Open Access
Published: 07 July 2023
Extracorporeal hemoadsorption therapy as a potential therapeutic option for rapid removal of Apixaban in high risk-surgical patients: a case report
Vittorio Dalmastri, Andrea Angelini, …Gaetano La Manna Show authors
Journal of Medical Case Reports volume 17, Article number: 283 (2023) Cite this article
Metricsdetails
Abstract
Background
Apixaban is a non-vitamin K antagonist oral anticoagulant (NOACs) recently emerged as an effective alternative to conventional vitamin K antagonists (VKAs) in the treatment of several thromboembolic disorders. However, in case of overdose or in patients requiring emergency surgery there is a high bleeding rate and severe adverse side effects due to the absence of an antidote. There is promising data from in vitro and clinical studies, that certain antithrombotic agents (that is Rivaroxaban and Ticagrelor) have been successfully removed by the extracorporeal hemoadsorption therapy CytoSorb. Here, we present the case of a patient successfully treated with CytoSorb as a kind of antidote to enable emergency surgery for bilateral nephrostomy.
Case presentation
A 82-year-old Caucasian man was admitted to the Emergency Room with acute kidney injury (AKI) in the context of severe bilateral hydroureteronephrosis. The patient’s medical history included chronic obstructive pulmonary disease, arterial hypertension, atrial fibrillation (anticoagulated with Apixaban) and a locally advanced prostate adenocarcinoma treated with trans-ureteral resection of the bladder and radiotherapy in the previous months. The indication for a bilateral nephrostomy could not be considered immediately given the major bleeding risk due to Apixaban, which was discontinued and replaced with calciparin. After 36 hours of continuous renal replacement therapy (CRRT), the Apixaban blood level was still elevated and it was decided to install CytoSorb into the running CRRT to accelerate the drug clearance. After 2 hours 30 minutes, there was good reduction of Apixaban from 139 to 72 ng/ml (reduction rate of 48.2%) registered, and this allowed for an easy placement of bilateral nephrostomies without complications. Four days after surgery renal function parameters further normalized, the patient did not require additional dialysis treatments and Apixaban therapy was prescribed again once the patient returned home.
Conclusions
In this case we report the findings of a patient with post-renal AKI requiring emergency nephrostomy placement while on chronic anticoagulation with Apixaban therapy. Combined treatment with CRRT and CytoSorb was associated with the rapid and effective removal of Apixaban allowing for prompt and urgent surgery while simultaneously ensuring the low risk of bleeding as well as an uneventful post-operative course.
Peer Review reports
https://link.springer.com/article/10.1186/s13256-023-03949-3
Cytosorbents (CTSO) Price Target Increased by 8.57% to 7.75
July 06, 2023 — 11:01 am EDT
Written by George Maybach for Fintel ->
The average one-year price target for Cytosorbents (NASDAQ:CTSO) has been revised to 7.75 / share. This is an increase of 8.57% from the prior estimate of 7.14 dated June 1, 2023.
The price target is an average of many targets provided by analysts. The latest targets range from a low of 5.56 to a high of 12.60 / share. The average price target represents an increase of 118.37% from the latest reported closing price of 3.55 / share.
https://www.nasdaq.com/articles/cytosorbents-ctso-price-target-increased-by-8.57-to-7.75
American Journal of Case Reports
IF 2022: 1.2
05 July 2023 : Case report Belgium
[In Press]ECMO and Extracorporeal Blood Purification with CytoSorb® Adsorber for Tricyclic Antidepressant Poisoning with Cardiogenic Shock and Severe Rhabdomyolysis
Management of emergency care, Educational Purpose (only if useful for a systematic review or synthesis)
Zakaria Zitoune ORCID logo1BCDEF, Luc Kugener ORCID logo2EF, Joop Jonckheer ORCID logo3EF, Katrien Lanckmans ORCID logo4BCD, Philippe Hantson ORCID logo5EF, Jacques Devriendt ORCID logo6EF, Patrick M. Honore ORCID logo1ABCDEF
DOI: 10.12659/AJCR.939884
Am J Case Rep In Press; DOI: 10.12659/AJCR.939884 The complete signature will be given at the time of publication
Available online: 2023-07-05, In Press, Corrected Proof
Publication in the "In-Press" formula aims at speeding up the public availability of the pending manuscript while waiting for the final publication. The assigned DOI number is active and citable. The availability of the article in the Medline, PubMed and PMC databases as well as Web of Science will be obtained after the final publication according to the journal schedule
Abstract
BACKGROUND
Tricyclic antidepressant (TCA) drugs are a common cause of fatal poisoning because of their cardiotoxic and arrhythmogenic effects. Classic supportive management includes sodium bicarbonate, gastrointestinal chelating agents, and vasopressors. Recently, intravenous lipid emulsion (supported by a low evidence level) has also been used.
CASE REPORT
We report the case of a 55-year-old woman admitted to our Intensive Care Unit (ICU) with acute imipramine self-poisoning. She arrived at the emergency department 7 hours after imipramine ingestion; she had severe rhabdomyolysis upon admission, with creatine phosphokinase levels at about 52 500 IU/L (normal, <200 IU/L).
She quickly developed cardiogenic shock and malign arrhythmia requiring veno-arterial extra corporeal membrane oxygenation (VA-ECMO). Continuous renal replacement therapy (CRRT) with CytoSorb® (CytoSorbents, Monmouth Junction, New York, United Sates of America) was started 19 hours after admission. We performed serial blood measurements of imipramine and its active metabolite desipramine as well as viewing the levels on the CRRT-circuit monitor. Cardiac function improved and ECMO was explanted after 4 days. She also had severe acute respiratory distress syndrome, which resolved spontaneously. The neurologic outcome was favorable despite early myoclonus. The patient regained consciousness on the fifth day. Her clinical evolution was marked by acute ischemia of the lower left limb due to the arterial ECMO cannula.
CONCLUSIONS
These measurements document the efficacy of the CytoSorb® adsorber in removing a lipophilic drug from a patient’s bloodstream. To our knowledge, this is the first published case of CytoSorb® extracorporeal blood purification therapy for acute TCA poisoning.
https://amjcaserep.com/abstract/index/idArt/939884
Case of the Month
Literature Database
Successful use of extracorporeal life support and hemadsorption in the context of venlafaxine intoxication requiring cardiopulmonary resuscitation: a case report
Matthias Hoffmann1, Samira Akbas1, Rahel Kindler2, Dominique Bettex1 | 1 Institute of Anesthesiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland | 2 Institute of Intensive Care Medicine, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland | J Artif Organs 2023; epub
07/05/2023
New!Case of the Week / Month
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Summary
CoM 07/2023 – This case reports on a 17-year-old female patient who was admitted to a regional hospital for mixed intoxication with a presumed intake of 24 g of venlafaxine (both immediate and extended-release preparations) and unknown amounts of oxycodone, zolmitriptan and itinerol B6.
Case presentation
The patient had been treated with venlafaxine by her outpatient psychiatrist for severe depression with suicidal ideation for two weeks prior to the event. An inpatient psychiatric stay had already been planned
Approximately five hours after taking the medication, the patient was found somnolent and brought to the hospital by ambulance
Due to the severity of the intoxication with the risk of developing hemodynamic instability, the patient was immediately transferred to the intensive care unit
Shortly after that, the patient went into status epilepticus
Because of this the patient was then analgosedated and intubated
After tracheal intubation, progressive hemodynamic deterioration occurred with sinus tachycardia up to 140 bpm, hypotension with systolic blood pressure of 70 mmHg and vasoconstriction (prolonged capillary refill time > 3 s)
ECG on the day of admission showed sinus tachycardia and a prolongation of cQT-time
Furthermore, echocardiography revealed severely impaired left ventricular function (Ejection Fraction – EF 10–15%) with hypokinetic left ventricle, apical and midventricular akinesia with normal right ventricular function. Pericardial effusion was excluded
Arterial blood gas analysis showed metabolic acidosis (pH 7.28) and a serum lactate of 7.8 mmol/l
Despite extended catecholamine therapy with high-dose norepinephrine, dobutamine and epinephrine, the patient could not be stabilized and cardiopulmonary resuscitation due to cardiac arrest had to be initiated
After 2.5 h (150 min) of mechanical resuscitation, extracorporeal life support (ECLS) system was established on-site with subsequent air-ambulance transfer to a tertiary hospital
Shortly after arrival at the tertiary hospital, a large volume of tablets (filling one-third of the stomach) was removed during primary decontamination via gastroscopy. The gastric mucosa was slightly hemorrhagic
A total of 55 g of activated charcoal was applied for additional adsorption. Because of her distended abdomen with subileus, repeated administration was withheld
Laboratory chemistry revealed disseminated intravascular coagulation (DIC) and acute liver failure with transaminase elevation, drop in coagulation factor V (Factor V: < 10%), INR elevation (max. INR 5.9) and lactic acidosis (lactate max. 9.8 mmol/l, pH min. 7.27), leading to the administration of N-acetylcysteine following Prescott schema for four days despite negative paracetamol serum levels
Sonographically, the liver was well perfused without obstructive intra- or extrahepatic cholestasis
Balanced hemodynamic management using volume and low-dose epinephrine (0.1 µg/kg/min) to promote inotropy, as well as high ECLS blood flow (maximum 5 l/min), were used to maintain sufficient
mean arterial pressure
Toxicological screening in urine and blood detected the metabolites of oxycodone, tramadol, nicotine and lidocaine, venlafaxine, metoprolol, metoclopramide, naloxone, and caffeine. In addition, iatrogenic amoxicillin, midazolam and levetiracetam metabolites were found
The initial compound venlafaxine plasma concentration was markedly elevated (maximum 52.53 µmol/l, therapeutic range of 0.7–1.44 µmol/l)
Therefore, a CytoSorb adsorber was initiated 6 h after admission to support drug removal
Treatment
Hemoadsorption treatment with CytoSorb was run for a total of 72 h with three adsorber changes during that time
The adsorber was integrated into a bypass within the running ECLS circuit
Blood flow rate: 300 ml/min
Measurements
Venlafaxine systemic plasma concentration
Left ventricular ejection fraction (LV-EF)
Results
Venlafaxine plasma concentrations were reduced significantly from a maximum of 52.53 µmol/l to 9.60 µmol/l within the first 12 hours. On day 2, it was 7.17 µmol/l and decreased further to 3.74 µmol/l
LV-EF increased steadily reaching ~22% at discontinuation of CytoSorb and ~36% on day 7
Patient Follow-Up
A 900 ml serous left pleural effusion was drained following the correction of coagulation on day four
The patient was anuric with acute kidney injury (AKIN stage 3, max. creatinine 331 µmol/l) and required continuous hemodiafiltration from day five
Already on admission, microbiological sampling was performed after documented aspiration and the established antimicrobial therapy with amoxicillin/clavulanic acid was continued
Despite negative bacterial detection, antimicrobial therapy was escalated to piperacillin/tazobactam on day eight due to respiratory deterioration and increasing inflammatory parameters (C-reactive protein peak level 154 mg/l)
The patient’s health condition progressively improved over the next few days
In addition to an increased blood pressure amplitude over 20 mmHg, serial transthoracic echocardiograms documented improved cardiac function and sufficient ejection fraction
Electrocardiographically, cQT peaked at 507 ms with no arrhythmias
Three days post-admission, levosimendan (0.1mcg/kg/min) intravenously (25 mg) facilitated weaning and removal of the ECLS system
Hepatic function recovered and after 7 days of high-volume hemodiafiltration, acid–base and fluid hemostasis were restored
The patient was transferred back to the peripheral hospital on day 11 post symptom onset and completely recovered neurologically and cardiopulmonarily
The discharge to inpatient psychiatric treatment was organized 31 days after the initial intoxication due to persistent suicidality
Conclusions
The combination of hemadsorption with CytoSorb with ECLS, along with traditional decontamination strategies, resulted in the intact neurological survival of the highest venlafaxine intoxication reported in the literature to date
The authors state this case supports the evidence that hemadsorption with CytoSorb might help to reduce blood serum levels of venlafaxine, and that swift clearance of toxic blood levels may support cardiovascular recovery after life-threatening intoxications.
New on PubMed
Extracorporeal liver support techniques: a comparison
Ivano Riva et al. J Artif Organs. 2023.
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J Artif Organs
. 2023 Jun 19.
doi: 10.1007/s10047-023-01409-9. Online ahead of print.
Authors
Ivano Riva 1 , Antonella Marino 2 , Tino Martino Valetti 3 , Gianmariano Marchesi 3 , Fabrizio Fabretti 3
Affiliations
1 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy. iriva@asst-pg23.it.
2 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy. antonellamar@gmail.com.
3 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy.
PMID: 37335451
DOI: 10.1007/s10047-023-01409-9
Cite
Abstract
ExtraCorporeal Liver Support (ECLS) systems were developed with the aim of supporting the liver in its detoxification function by clearing the blood from hepatic toxic molecules. We conducted a retrospective comparative analysis on patients presenting with liver failure who were treated with different extracorporeal techniques in our intensive care unit to evaluate and compare their detoxification abilities. To verify the effectiveness of the techniques, mass balance (MB) and adsorption per hour were calculated for total bilirubin (TB), direct bilirubin (DB), and bile acids (BA) from the concentrations measured. MB represents the total amount (mg or mcMol) of a molecule removed from a solution and is the only representative parameter to verify the purification effectiveness of one system as it is not affected by the continuous production of the molecules, released in the circulation from the tissues, as it is the case for the reduction rate (RR). The total adsorption per hour is calculated by the ratio between MB and the time duration and shows the adsorption ability in an hour. Our comparative study shows the superior adsorption capability of CytoSorb system regarding TB, DB, and BA, evaluated through the MB and adsorption per hour, in comparison with CPFA, MARS, Prometheus, and PAP. In conclusion, as extracorporeal purification in liver failure could be considered useful for therapeutic purposes, Cytosorb, being more performing than other systems considered, could represent the device of first choice.
Keywords: Extracorporeal support; Liver failure; Liver support.
CytoSorbents Announces Independent Data Safety and Monitoring Board Recommends Completion of the Pivotal STAR-T Trial Without Modifications Following Second Scheduled Safety Review
PRINCETON, N.J., June 15, 2023 — 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 received the recommendation from the independent Data and Safety Monitoring Board (DSMB), following the second scheduled safety review, to complete the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “We would like to thank the independent DSMB for the prompt review of the full unblinded dataset from the first 80 patients enrolled in the STAR-T trial. We are very pleased with the recommendation to continue the study as planned without modifications that now allows us to push towards the finish line in an expedited fashion. Based on the continued excitement and strong contributions from our U.S. and Canadian investigative sites, we continue to project that the trial, which remains blinded, will complete enrollment this summer.”
The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study being conducted in both the U.S. and Canada that is designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
Avenir Corp Buys 132,235 Shares of Cytosorbents Co. (NASDAQ:CTSO)
"Avenir Corp increased its stake in Cytosorbents Co. (NASDAQ:CTSO - Get Rating) by 5.7% during the fourth quarter, according to its most recent filing with the Securities and Exchange Commission. The firm owned 2,447,089 shares of the medical research company's stock after purchasing an additional 132,235 shares during the quarter. Cytosorbents makes up approximately 0.4% of Avenir Corp's portfolio, making the stock its 24th biggest holding. Avenir Corp owned 5.61% of Cytosorbents worth $3,793,000 at the end of the most recent reporting period.
A number of other hedge funds also recently modified their holdings of the stock. Millennium Management LLC bought a new stake in Cytosorbents during the 2nd quarter valued at $1,149,000. Skylands Capital LLC raised its holdings in Cytosorbents by 8.3% during the 4th quarter. Skylands Capital LLC now owns 2,542,091 shares of the medical research company's stock valued at $3,940,000 after acquiring an additional 195,057 shares during the period. Goldman Sachs Group Inc. raised its holdings in Cytosorbents by 129.6% during the 1st quarter. Goldman Sachs Group Inc. now owns 298,877 shares of the medical research company's stock valued at $954,000 after acquiring an additional 168,712 shares during the period. Neuberger Berman Group LLC raised its holdings in Cytosorbents by 11.4% during the 3rd quarter. Neuberger Berman Group LLC now owns 1,479,570 shares of the medical research company's stock valued at $2,003,000 after acquiring an additional 151,300 shares during the period. Finally, Citadel Advisors LLC grew its position in shares of Cytosorbents by 461.4% during the 2nd quarter. Citadel Advisors LLC now owns 126,898 shares of the medical research company's stock valued at $278,000 after purchasing an additional 104,296 shares in the last quarter. Institutional investors own 34.04% of the company's stock."
https://www.marketbeat.com/instant-alerts/nasdaq-ctso-sec-filing-2023-06-12/
Nobody asked me but that was a good meeting today. Organized, positive, prepared, pertinent. They did well.
Looks like blocks husband added to his retirement account
Intraoperative ticagrelor removal via hemoadsorption during on-pump coronary artery bypass grafting
Hassan K, Geidel S, Zamvar V, Tanaka K, Knezevic-Woods Z, Wendt D, Deliargyris EN, Storey RF, Schmoeckel M. JTCVS 2023; epub
05/2023
This three centre study prospectively included 11 patients on ticagrelor undergoing urgent coronary artery bypass graft (CABG) surgery. CytoSorb hemoadsorption was incorporated in the cardiopulmonary bypass (CPB) circuit and remained there for the duration of the pump run. Blood samples were collected pre and post CPB so that mean ticagrelor levels could be measured. The time interval between surgery and last ticagrelor dose was £48 hrs and the mean intraoperative hemoadsorption duration was 97 minutes with a mean flow rate through the device of 422 mL/min. Mean ticagrelor levels pre-CPB were 103±63.8 ng/mL compared to mean post CPB levels of 34.0±17.5 ng/mL (significant reduction of 67.1%, p< 0.001). There were no re-operations performed for bleeding and no BARC-4 bleeding events occurred. Median chest tube drainage over 24 hours was 520mL (375mL-930mL). Intraoperative integration of CytoSorb into the CPB circuit was simple and safe without any device related adverse events reported. This is the first in vivo report showing that the intraoperative use of CytoSorb can efficiently remove ticagrelor and significantly reduce circulating drug levels. As the authors state, whether this active removal can reduce serious postoperative bleeding in patients undergoing urgent cardiac surgery is currently being evaluated in the double blinded randomized Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial.
No opinion at this time
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.
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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
Download documentDownload document
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?
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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."
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