Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
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
----------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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?
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
StreetInsider
Get Quote
Upgrade to SI Premium - Free Trial
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
Download documentDownload document
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.
Well, further, I’m taking the liberty of posting this recent video. Wes Christian. FWIW. Worth the watch. IMO.
Well, likely many ways to illegally manipulate the stock. These little biotechs are ripe for abuse. As our their retail investors. Moms and pops. I believe it needs to end, if.
The NWBO lawsuit alleges a particular form of illegal stock manipulation known as “spoofing”. If it gets to discovery, well, other forms of associated illegal manipulation may be, well, discovered.
Perhaps CTSO, Dr Chan, CTSO shareholders, have felt that CTSO shares have been illegally manipulated. Cohen Milstein may be able to assist. Looks like they brought a pretty solid case forward.
I doubt NWBO is the only company/equity illegally manipulated, if. It is likely a pattern and practice, of sorts, if.
They (NWBO/Cohen Milstein) appear to have solid evidence suggesting such, illegal, manipulation.
These are companies working to to save lives. Unconscionable.
Best, biotech48.
I dunno, great find. I have felt that Dr. Lowenstein and his multiple aliases have been doing the same manipulation at CTSO over the years. I believe that they are still here. Here's the thing. I read everything I can regarding CTSO and also believe that they manipulated it both up and down.
And, to whom it may concern, if, … https://www.cohenmilstein.com/practice-area/sec-and-cftc-whistleblower-programs
Anyway. Just find it all so, intriguing.
Good to see CTSO moving up. It sure got hit hard on the way down. Hope it was all legit, and not in any way illegally manipulated down, in any way, by any illegal stock manipulation, in concert with any other activities. Hope not.
I wonder if Cohen Milstein could offer any insight. If.
Best. Just thinking out loud.,
Friends. I think this law suit is WELL worth the read. The entire complaint. You might find some similarities.
I think Dr Chan could be interested.
https://www.cohenmilstein.com/sites/default/files/NWBO%20v.%20Canaccord%20et%20al%20-%20Complaint%2012012022%20-.pdf
Dr lowenstein ?? Are you still here? It’s been how long?? What, 10-12 -14 YEARS???
And you moved over to NWBO, to “warn” retail investors there, too, much like you’ve been doing in CTSO for years…???
Huh. Interesting. I wonder if CTSO investors would be interested to learn that another company, NWBO, which you have also spent considerable time and effort, mocking, (NWBO, and their CEO Linda Powers, working on a treatment for cancers) has sued Citadel and other market makers for manipulating their stock price for YEARS.
Much as you’ve done here, to CTSO. Mocking CTSO and Dr Chan. Coincidence?? Coincidence?? Coincidences???
Stock manipulation. Dr lowenstein? Thoughts? Coincidence?
https://www.cohenmilstein.com/update/northwest-biotherapeutics-files-lawsuit-against-major-market-makers-market-manipulation
Case of the Week
Use of CytoSorb in a patient with severe polytrauma and ARDS following a motorbike accident
Dr. med. Christoph Busjahn Clinic and Polyclinic for Anesthesiology and Intensive Care, Rostock University Medical Centre, Rostock, Germany
01/04/2023
MyoglobinNew!Reduction in catecholaminesSafetyTraumaImprov. fluid balanceAnticoagulation HeparinARDSCase of the Week / MonthCase reportCritical CareECMO-VVInflammatory parameters
Download documentDownload document
Summary
CoM 01/2023 – This case reports on a 20-year-old patient with no relevant medical history, who was admitted to the emergency room with severe polytrauma after hitting a stationary car whilst on his motorbike.
Case presentation
In the shock room, while he was still breathing spontaneously, rapid pulmonary deterioration occurred so that emergency intubation was performed immediately
The main injuries diagnosed in the course of the initial assessment included: avulsion of the left main bronchus with bilateral hemato-pneumothorax, extensive pulmonary contusions with hemorrhages, cervical soft tissue emphysema and soft tissue hematoma, various rib fractures, right clavicle fracture, left scapula fracture, fracture of the manubrium sterni, left tripod fracture, dislocated multi-fragmentary fractures of the left maxillary sinus walls, right petrous bone longitudinal fracture, fractures of the left proc. transversi, non-displaced fracture of the proc. spinosus, multi-fragmentary fractures of the left pelvic scapula, left distal ulnar shaft fracture, suspected rupture of the anterior cruciate ligament and medial collateral ligament of the left knee joint, contusio cordis (contusion of the heart in the context of the thoracic trauma), splenic laceration (grade II), a craniocerebral trauma as well as a subcapsularly dorsal liver contusion/hematoma in the right liver lobe and also diffuse intraparenchymal hematoma in the right liver lobe
Subsequently, veno-venous extracorporeal membrane oxygenation (vv-ECMO) therapy was commenced due to his actively bleeding bronchus injury and the patient was transferred to the perioperative intensive care unit (ICU) intubated and ventilated in a controlled ventilation mode, already requiring high catecholamines (0.6 µg/kg/min)
The bronchus injury was treated with a thoracotomy with resection of the left upper lobe by colleagues from the thoracic surgical team
Diagnostic laparoscopy and gastroscopy were performed in the same time without further therapeutic consequences
In addition, mass transfusions were necessary in the context of his hemorrhagic shock with anemia (a total of 19 red cell concentrates, 19 units of fresh frozen plasma, 9 platelet concentrates)
Already intraoperatively, increased lactate levels were noted. Postoperatively, the patient then exhibited increased volume and catecholamine requirements with ongoing increases in lactate levels
Due to pronounced acute respiratory distress syndrome (ARDS), proning therapy was required and maintained for 4 days
After postoperative transfer to the ICU, CytoSorb therapy was started to control the hyperinflammatory situation, to achieve hemodynamic stabilization and to potentially avoid pulmonary hyperhydration and edema through reduced volume requirements
Treatment
Consecutive use of 2 CytoSorb adsorbers over a period of 41 hours (1st adsorber 15 hours, 2nd adsorber 26 hours)
Integration of the adsorber as bypass into the vv-ECMO circuit (Xenios console, Fesenius Medical Care) via the ECMO connections offered by CytoSorbents
Anticoagulation: initially without, then in the second treatment 200 IU/h heparin, with a target pTT of 40 – 45 sec
Measurements
Hemodynamics and catecholamine requirements
Inflammatory parameters
Metabolic parameters
Fluid balance
Myoglobin
Results
Under combined CytoSorb and vv-ECMO therapy, catecholamine requirements could be clearly reduced. Within 24 hours, norepinephrine demand was lowered to 0.09 µg/kg/min and could be stopped already on the first post op day
Treatment also led to a control of the hyperinflammatory situation as evidenced by a rapid reduction in interleukin-6 plasma levels and a normalization in leukocyte levels after the start of the hemoadsorption therapy
Already 5 hours after initiation of CytoSorb therapy, serum lactate had decreased from 9.8 to 4.8 mmol/l. Levels trended downwards over time reaching normal values 26 hours after the start of Cytosorb therapy
In parallel, the pH value normalized already during the first CytoSorb treatment
In addition, total fluid balance for the first 24 hours was only 1.5 litres and 2.6 litres for the first 48 hours. On day 3, this increased again by 2.3 litres. Afterwards, a negative fluid balance could be achieved throughout
Furthermore, therapy was associated with a rapid and sustained reduction in myoglobin and creatine kinase plasma levels
Patient Follow-Up
Bronchoscopies were repeatedly required due to viscous secretions and diffuse bleeding tendencies. HSV-1 was detected in the tracheal secretions, so that anti-viral therapy with aciclovir was started
Due to wide-complex tachycardia following contusio cordis, continuous amiodarone therapy was started, which was terminated after he converted back to sinus rhythm
As the duration of ventilation was expected to be long, a dilatative tracheotomy was performed on day 5 in the ICU. During the subsequent weaning period, the patient could tolerate spontaneous breathing trials and was able to breath adequately with stable gas exchange on Continuous Positive Airway Pressure (CPAP)
With sufficient improvement of pulmonary gas exchange and an increasing bleeding tendency in the context of an acquired von Willebrand syndrome, vv-ECMO therapy was discontinued after a total of 8 days
The last tracheal cannula change was performed on day 10 after admission to the ICU
Surgical treatment of the ulna fracture was performed by the trauma surgery team one week later
Given his pronounced stress reaction and agitation, sedation was extended until the patient could finally be weaned
At the time of transfer, the patient was awake, fully oriented, normotensive, catecholamine-free and breathing 3 x 2 hours a days using a heat and moisture exchanger
Conclusions
In this patient with severe polytrauma, hemorrhagic shock, traumatic brain injury and ARDS, the use of CytoSorb in combination with other therapeutic measures was associated with hemodynamic stabilization, control of the hyperinflammatory response, resolution of metabolic acidosis and reduction in myoglobin and creatine kinase levels
According to the authors, CytoSorb was helpful in this particular case for rapid control of the hyperinflammation in the setting of trauma and for achieving hemodynamic stability without massive volume overload. Contrary to all expectations, the use of CytoSorb prevented a significant positive fluid balance and thus an additional burden, especially to the lungs
The use of CytoSorb in combination with vv-ECMO proved to be safe and simple.
Andy, another miracle and life saved by Cytosorb.
Downside to owning losers like this garbage, one day losses of 18% for end of year tax write offs..
CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications
PRINCETON, N.J., December 21, 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 received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue 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, “The independent DSMB has completed the review of the full unblinded dataset from the first 40 patients enrolled in the STAR-T trial and we are very pleased to receive the recommendation to continue the study as planned without any modifications. All our clinical resources continue to focus on enrollment with the goal of achieving the next milestone of 80 patients enrolled by Spring 2023, triggering another safety review and the execution of the trial’s prespecified interim analysis by the independent DSMB.”
The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study 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.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management's current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
Case of the Week
The Sequential Use of Extracorporeal Cytokine Removal Devices in an Adolescent With COVID-19 Receiving Continuous Renal Replacement Therapy
Wun Fung Hui1, Renee Wan Yi Chan2,3,4,5 , Chun Kwok Wong6, Ka Hang Andy Kwok1, Wing Lum Cheung1, Fung Shan Chung1, Karen Ka Yan Leung1, Kam Lun Hon1, Shu Wing Ku1 1Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital, Hong Kong. 2Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 3Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong. 4Laboratory for Paediatric Respiratory Research, Li Ka Shing Institute of Health Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 5CUHK-UMCU Joint Research Laboratory of Respiratory Virus & Immunobiology, Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 6Department of Chemical Pathology, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. ASAIO J 2022; 68(12):e230-e234
12/21/2022
New!Peer Reviewed Published DataViral infectionCase of the Week / MonthCase reportCOVID-19Critical CareCRRT post filterInflammatory parameters
Download documentDownload documentLink to source
Summary
CoW 43/2022 – This case reports on an a 14-year-boy (43 kg) without any respiratory symptoms, who was admitted to a regional hospital with a fever of one day associated with vomiting and breakthrough seizures.
Summary
A 14-year-old male (43kg) developed multisystem inflammatory syndrome in children (MIS-C) after acquiring the SARS-CoV-2 infection. He deteriorated rapidly requiring inotropic and ventilatory support as well as continuous renal replacement therapy (CRRT) due to rhabdomyolysis-associated acute kidney injury. CytoSorb was first incorporated into the post-CRRT filter circuit for myoglobin and cytokine removal (hour 18 – 40), which was followed by sequential use of Oxiris (hour 40 – 80), followed by another CytoSorb adsorber (hour 85 – 110), giving a total of 100 hours of extracorporeal blood purification [EBP] therapy. There were no major complications related to the EBP therapy including hemodynamic compromise. Cytokine profile revealed a marked reduction of levels of several cytokines including tumor necrosis factor-alpha (TNFa), interleukin (IL)-6, IL-8, and IL-10 after the EBP therapy. It was noted that both pro-inflammatory and anti-inflammatory cytokines were removed, and the removal efficacy varied between different devices. The authors note that the two devices appeared to complement each other’s adsorption capacity. His condition improved and the serum ferritin, C-reactive protein, and procalcitonin levels also dropped gradually, which correlated well with his clinical progress and the trend of cytokine levels. The authors conclude that this case demonstrates that extracorporeal cytokine removal can be safely applied in children with MIS-C and can be considered as adjunctive therapy in selected patients with critically ill conditions.
Case presentation
Known medical history included a de novo G-Protein Subunit Alpha O1 (GNAO1)-mutation with movement disorder, epilepsy, and severe intellectual disability receiving baclofen, tetrabenazine, carbamazepine, and clobazam
On admission, his temperature was 40.1°C, heart rate 150/min, blood pressure 90/50 mmHg, and desaturation requiring oxygen supplementation
He exhibited vigorous involuntary movements and developed a status dystonicus
Blood tests on admission showed a white blood cell count of 9.1×109/L (neutrophil and lymphocyte count of 7.7×109/L and 0.9 × 109/L, respectively), urea 2.9 mmol/L, creatinine 41 µmol/L (baseline creatinine level was 31 µmol/L) and creatine kinase (CK) level of 117575 IU/L. Moreover, he was also found to pass brownish-red (myoglobin-positive) urine
He went on to develop disseminated intravascular coagulation with thrombocytopenia with an abnormal clotting profile (INR 1.7, aPTT >120 s, D-dimer 5072.9 ng/ml and fibrinogen 2.24 g/L)
The nasopharyngeal swab proved positive for SARS-CoV-2
He was started on hyperhydration, empirical piperacillin/tazobactam and one dose of remdesivir
Oral chloral hydrate was used for sedation
Urine output was maintained at 2–3 ml/kg/hour but the persistent fever and tachycardia continued, as did the excessive movements
He later developed stage 2 acute kidney injury (AKI) with an estimated glomerular filtration rate (eGFR) of 75 ml/min/1.73 m2 and was therefore transferred to the pediatric intensive care unit (PICU) for further management
His CK level rose sharply to the peak level of 449,100 IU/L with hypernatremia (sodium level of 155 mmol/L) and metabolic acidosis (pH 7.33, bicarbonate level of 13.8, and base excess of -11.8 mmol/L)
The lactate level was 2.3 mmol/L, troponin-T level was 170 ng/L and the eGFR reduced to 66 ml/min/1.73m2
He developed abnormal liver function tests with serum levels of alanine aminotransferase (ALAT) 1469 IU/L, aspartate aminotransferase (ASAT) 6577 IU/L, and ammonia 52 µmol/L
There were also elevated levels of inflammatory markers including ferritin 5842 pmol/L, procalcitonin 13.63 ng/ml, and C-reactive protein (CRP) 130 mg/L
The clinical diagnosis was multisystem inflammatory syndrome in children (MIS-C) related to SARS-CoV-2 infection triggering status dystonicus and subsequent rhabdomyolysis-associated AKI
After his transfer to the PICU, his blood pressure dropped to 60/40mmHg and SpO2 was 90%
A bedside echocardiogram showed impaired septal motion and mildly impaired left ventricular contractility with fractional shortening of 25%
He subsequently required intubation for respiratory failure, and a norepinephrine infusion was started at 0.03 µg/kg/min for hemodynamic support
Multiple sedative medications were used for sedation and control of his dystonia and dyskinesia in addition to his usual medications
Remdesivir was not continued due to his impaired liver function. Tocilizumab was starter later
He was started on continuous renal replacement therapy (CRRT) due to rhabdomyolysis-associated AKI
Ten hours after CRRT initiation, a CytoSorb hemoadsorption column was integrated into the CRRT circuit to enhance myoglobin and cytokine removal
Treatment
CytoSorb was first incorporated into the CRRT circuit for myoglobin and cytokine removal (hour 18 – 40), which was followed by sequential use of Oxiris (hour 40 – 80), followed by another CytoSorb adsorber (hour 85 – 110), giving a total of 100 hours of extracorporeal blood purification [EBP] therapy
CytoSorb was used in conjunction with CRRT run in high-volume continuous veno-venous hemodiafiltration (HF CVVHDF) mode using the Prismaflex system
Position of the adsorber: post-CRRT filter
Measurements
Hemodynamics and catecholamine requirements
Inflammatory parameters
Creatine kinase
Results
Initially, he continued to deteriorate with persistent hypotension requiring escalation of inotropes. However, there were no major complications related to the EBP therapy including hemodynamic compromise
Cytokine profile revealed a marked reduction of levels of several cytokines including tumor necrosis factor-alpha (TNFa), interleukin (IL)-6, IL-8, and IL-10 after the EBP therapy. His condition improved under both EBP therapies and the serum ferritin, C-reactive protein, and procalcitonin levels also dropped gradually, which correlated well with his clinical progress and the trend of cytokine levels
The serum levels of CK gradually decreased
Patient Follow-Up
A dose of intravenous immunoglobulin (IVIG) and dexamethasone were added during therapy
It was possible to stop all inotropes 4 days after PICU admission
Extubation was possible on 8th day of PICU admission
The CRRT doses were gradually reduced, and it was possible to stop CRRT support 8 days after admission
The clinical course was complicated by secondary Pseudomonas aeruginosa pneumonia requiring an additional course of antibiotics for two weeks
The patient was finally discharged from the PICU to his original hospital one month after admission
Conclusions
In this case of an adolescent with MIS-C following SARS-CoV-2 infection as well as rhabdomyolysis-associated acute kidney injury, the application of extracorporeal blood purification therapy was associated with pronounced hemodynamic stabilization, as well as a marked reduction in levels of several cytokines and creatine kinase
It was noted that both pro-inflammatory and anti-inflammatory cytokines were removed, and the removal efficacy varied between different devices. However, the authors note that the two devices (CytoSorb + Oxiris) appeared to complement each other’s adsorption capacity
The authors conclude that this case demonstrates that extracorporeal cytokine removal can be safely applied in children with MIS-C and can be considered as adjunctive therapy in selected patients with critically ill conditions.
I voted against Chan and all the board of directors except the latest one hired. Chan has been in charge for 13 years and look at the price of the stock today! The best thing he is good at is making excuses.
Wow. what garbage, How do these losers keep their jobs?
New on PubMed
Case Reports
A rare case of acute liver failure with intrahepatic cholestasis due to dengue hemorrhagic fever: CytoSorb® and plasma exchange aided in the recovery: case report
Arosha Minori Gunasekera et al. BMC Infect Dis. 2022.
Hide details
BMC Infect Dis
. 2022 Dec 13;22(1):938.
doi: 10.1186/s12879-022-07933-y.
Authors
Arosha Minori Gunasekera 1 , Udeshan Eranthaka 2 , Dilshan Priyankara 2 , Ranjith Kalupahana 2
Affiliations
1 National Hospital of Sri Lanka, Colombo, Sri Lanka. arosha.minorig@gmail.com.
2 National Hospital of Sri Lanka, Colombo, Sri Lanka.
PMID: 36514003
DOI: 10.1186/s12879-022-07933-y
Cite
Abstract
Background: Dengue haemorrhagic fever is a severe form of acute dengue infection characterized by leakage of plasma through capillaries into body spaces resulting in circulatory insufficiency leading to shock. Despite varying degrees of liver involvement occurring in acute dengue infection, intrahepatic cholestasis is very rare in the literature with only two cases reported so far. We report a challenging case of a middle-aged woman with DHF complicated by acute liver failure, coagulopathy, acute renal failure and prolonged intrahepatic cholestasis. She was successfully managed in the intensive care unit with supportive therapy, Cytosorb® and therapeutic plasma exchange.
Case presentation: A 54-year-old Sri Lankan obese woman with multiple comorbidities presented with fever, headache, vomiting and generalized malaise for 3 days and was diagnosed with dengue haemorrhagic fever. Despite the standard dengue management, she clinically deteriorated due to development of complications such as, acute liver injury, intrahepatic cholestasis and acute renal injury. Acute liver failure was evidenced by transaminitis, lactic acidosis, coagulopathy with pervaginal bleeding and severe encephalopathy necessitating elective intubation and mechanical ventilation. She was immediately transferred to intensive care facilities where she underwent supportive management for liver failure, continuous renal replacement therapy coupled with cytosorb and therapeutic plasma exchange with which she made a remarkable recovery.
Conclusion: Acute liver failure with a prolonged phase of intrahepatic cholestasis is a very rare complication of acute dengue illness which is sparsely documented in medical literature so far. This patient was managed successfully with supportive therapy, aided by cytoSorb hemo-adsorption and therapeutic plasma exchange.
Keywords: Acute liver failure; Cholestasis; Cytosorb®; Dengue fever; Dengue haemorrhagic fever; Therapeutic plasma exchange.
I was being sarcastic. Unfortunately the jokes on me/all of us.
Down .40 in a month
He is not a businessman. He is a scientist. At least his shares are worthless now also. It’s unbelievable a product like this hasn’t got traction in this amount of time. The uses are endless. Yet nothing. But they do 30 mil rev. That keeps the float in check till they give Chan more that POS FUK
Case of the Week
Literature Database
Use of hemadsorption in pediatric meningococcal sepsis, Waterhouse-Friderichsen-Syndrome, and multiple organ failure
Guido Mandilaras, Simone Katrin Dold, Robert Dalla Pozza Division of Pediatric Cardiology and Pediatric Intensive Care, University Hospital, LMU Munich, Munich, Germany. Open Journal of Clinical & Medical Case Reports 2022; 8(12):1889
12/13/2022
New!PediatricsReduction in catecholaminesSafetySeptic ShockAnticoagulation HeparinCase of the weekCase reportCritical CareCRRT (pre or post filter)Inflammatory parameters
Download documentDownload documentDownload document
Summary
CoW 42/2022 – This case reports on an 18-year-old male without relevant medical history, who presented at the emergency room of a peripheral primary care hospital with nausea and headaches.
Summary
Community-acquired bacterial meningitis still represents one of the most important infectious diseases worldwide and remains a substantial cause of mortality and morbidity, particularly in both the very young and the elderly patients. The disease is characterized by a hyperinflammatory response with a rapid and excessive production of inflammatory mediators, accompanied by disseminated intravascular coagulation (DIC) and development of Waterhouse–Friderichsen syndrome. Extracorporeal blood purification therapies represent a new therapeutic approach since they seem to be able to attenuate this detrimental process by lowering systemic cytokine levels. We herein report on an 18-year-old previously healthy male who had to be intubated and mechanically ventilated shortly after hospital admission followed by confirmation of Neisseria meningitidis infection. Antibiotic as well as catecholamine and volume therapy were initiated. Over time he developed excessive hyperinflammation, Waterhouse-Friderichsen-syndrome with purpura fulminans, hyperlactatemia and progressive renal failure, leading to the initiation of combined renal replacement and CytoSorb hemoadsorption therapy. This resulted in significant decrease in inflammatory parameters and a progressive reduction in catecholamine and lactate levels while peripheral perfusion was restored preventing any loss of extremities. The patient could be extubated 10 days after PICU admission. No adverse or unwanted device-related side effects were documented. In conclusion, this case report is supporting other promising results in this highly sensitive patient cohort, by showing rapid hemodynamic stabilization and control of hyperinflammation being associated with the use of CytoSorb, however, evidence on the application of the CytoSorb adsorber in pediatrics remain rather sparse and more clinical data are needed.
Case presentation
During the hospital admission process, the patient rapidly developed petechiae over his entire body, resulting in the preliminary diagnosis of meningococcal sepsis
Following initiation of antibacterial therapy with cefotaxime (2 x 4g iv) and ampicillin (3 x 5g iv) as well as administration of dexamethasone (3 x 10 mg iv), the patient had to be intubated due to respiratory insufficiency and a central venous and arterial catheters were inserted
Subsequently, catecholamine (norepinephrine 0.8 mg/h) and volume therapy (2 l isotonic saline, 2000 IE prothrombin complex, 2x fresh frozen plasma, 1x platelet concentrate) were started due to progressive hemodynamic instability
Microbiological analysis of the liquor puncture confirmed presence of Neisseria Meningitidis type B bacteria
The mechanically ventilated patient was then transferred under ongoing catecholamine therapy to the pediatric intensive care (PICU) unit for further diagnosis and therapy
At this time, clinically the patient was exhibiting a picture of full-blown Waterhouse-Friderichsen-syndrome with purpura fulminans accompanied by ubiquitous petechial hemorrhages and hyperlactatemia (max. 10.8 mmol/l)
Hydrocortisone administration was started according to the guidelines (50 mg/m² body surface) along with sedation with midazolam, and sufentanyl, which was later complemented by propofol and dexmedetomidine
Antibiotic therapy was supplemented by tobramycin and his disseminated intravascular coagulopathy (DIC) was treated by means of repeated doses of fresh frozen plasma, platelet concentrates, and vitamin K
Echocardiography revealed a restricted cardiac function with an ejection fraction of 31% and inotropic therapy was extended by epinephrine and milrinone, accordingly
Mechanical ventilation had to be intensified because of increasing bronchial secretions and left atelectasis (max positive end-expiratory pressure [PEEP] 10 mbar)
Due to progressive renal failure with elevated retention parameters, continuous renal replacement therapy (CRRT) was started five hours after PICU admission and approximately twelve hours later a CytoSorb hemoadsorber was additionally added to the circuit to control excessive hyperinflammation (Interleukin – IL-6 >200,000 pg/ml)
Treatment
Two CytoSorb treatment sessions were performed for a total duration of approximately 50 hours
CytoSorb was used in combination with CRRT run in continuous veno-venous hemodiafiltration (CVVHDF) mode
Blood flow rate: 120 ml/min
Anticoagulation: heparin
Measurements
Hemodynamics and catecholamine requirements
Inflammation
Lactate
Respiratory status
Cardiac function
Sequelae of DIC
Results
Therapy resulted in early and rapid hemodynamic stabilization accompanied by a prompt decrease in norepinephrine and epinephrine doses. The epinephrine infusion could already be tapered off at the end of the second hemoadsorption session
During combined CVVHDF and hemoadsorption treatment, there was also a significant decrease in inflammatory parameters noted, pointing towards control of the hyperinflammatory state. IL-6 levels reduced from >200,000 to 770 pg/ml within the first 48 hours of combined therapy
Lactate levels also reduced progressively
The respiratory situation stabilized during treatment and cardiac function started to improve
Additionally, there were no further petechial hemorrhages, and no peripheral ischemia observed with no loss of extremities in the follow-up period
Patient Follow-Up
Continuous hemodiafiltration was switched to intermittent dialysis as renal function consecutively improved as evidenced by a normalization in retention parameters and return of spontaneous diuresis
The pulmonary situation slowly improved with inhalation and repeated bronchoscopy with bronchial lavage, so that the patient could be extubated 10 days after PICU admission
Ongoing follow-up was characterized by mild delirium and development of critical illness neuropathy with pronounced tremors, which, however, resolved during his stay
Two weeks after admission to the PICU, the patient was transferred to the general pediatric ward in a stable clinical condition with a normal cardiac function (EF 70%) and was discharged from the hospital shortly afterwards
Conclusions
Treatment in this adolescent patient with meningococcal sepsis, Waterhouse-Friderichsen-Syndrome, and multiple organ failure was associated with a rapid and significant reduction in plasma cytokine levels, accompanied by improved hemodynamics, normalization of plasma lactate levels and restored peripheral perfusion preventing any loss of extremities
As such, this case report supports other promising results in this highly sensitive patient cohort
The very positive clinical course in our case does not imply that there was relevant removal of any of the antibiotics used
No adverse or device-related side effects were documented during or after the treatment sessions and the combination was practical, technically feasible and appeared to be highly beneficial for the patient.
New on PubMed
Hemoadsorption in Complex Cardiac Surgery-A Single Center Experience
Murali Manohar et al. J Clin Med. 2022.
Hide details
J Clin Med
. 2022 Nov 27;11(23):7005.
doi: 10.3390/jcm11237005.
Authors
Murali Manohar 1 , Vivek Jawali 1 2 , Siddu Neginahal 3 , Sudarshan Gt 1 , Geetha Muniraj 4 , Murali Chakravarthy 4
Affiliations
1 Cardiac Surgery Department, Fortis Hospital, Bengaluru 560076, India.
2 Cardiac Sciences Board, Fortis Hospital, Bengaluru 560076, India.
3 Cardiac Surgery Perfusion Department, Fortis Hospital, Bengaluru 560076, India.
4 Anaesthesia Department, Fortis Hospital, Bengaluru 560076, India.
PMID: 36498579
DOI: 10.3390/jcm11237005
Cite
Abstract
(1) Background: Cardiac surgery may evoke a generalized inflammatory response, typically magnified in complex, combined, redo, and emergency procedures with long aortic cross-clamp times. Various treatment options have been introduced to help regain control over post-cardiac surgery hyper-inflammation, including hemoadsorptive immunomodulation with CytoSorb®. (2) Methods: We conducted a single-center retrospective observational study of patients undergoing complex cardiac surgery. Patients intra-operatively treated with CytoSorb® were compared to a control group. The primary outcome was the change in the vasoactive-inotropic score (VIS) from pre-operatively to post-operatively. (3) Results: A total of 52 patients were included in the analysis, where 23 were treated with CytoSorb® (CS) and 29 without (controls). The mean VIS increase from pre-operative to post-operative values was significantly lower in the CS group compared to the control group (3.5 vs. 5.5, respectively, p = 0.05). In-hospital mortality in the control group was 20.7% (6 patients) and 9.1% (2 patients) in the CS group (p = 0.26). Lactate level changes were comparable, and the median intensive care unit and hospital lengths of stay were similar between groups. (4) Conclusions: Despite notable imbalances between the groups, the signals revealed point toward better hemodynamic stability with CytoSorb® hemoadsorption in complex cardiac surgery and a trend of lower mortality.
Keywords: aortic surgery; blood purification; complex cardiac surgery; cytokines; cytosorb; hemoadsorption; hyperinflammation; redo.
Chan just bought some shares @ $1.26 & $1.264. Guess he at least likes the stocks and its potential.
What we are missing is a good CEO! We have one that is self -centered self-serving over paid and compensated for the job he has done. He is great at making excuses!
Thank you! Reading these, it's inconceivable/inexplicable as to why the stock performs as it does, or why they can't sell more. What are we all missing?
Followers
|
241
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
27409
|
Created
|
10/18/08
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |