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So now Google Jason Kolbert of Dawson James. He's reiterating his "Buy" rating. The problem? Like my previous Sean Lee post, he is atrocious as an analyst. Ranked 7150 out of 7900. Do any successful people put a rec on CTSO? The headline makes us all feel good until you dig a little.
That's one inept incompetent down, several more to go (at a minimum).
NEWS -- CytoSorbents Announces Pending Retirement of Chief Financial Officer Kathleen P. Bloch
PRINCETON, N.J., Oct. 7, 2022 /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, announced today that its Chief Financial Officer, Kathleen P. Bloch, MBA, CPA, plans to retire on March 31, 2023 at age 68, following a distinguished decade-long career at the Company. A search has been initiated for Ms. Bloch's replacement. Meanwhile, following her retirement next year, Ms. Bloch will continue as a consultant of the Company to provide, among other services, continuity during the transition of her successor.
Ms. Bloch stated, "It has been a privilege and a pleasure to be a part of the incredible team at CytoSorbents over the past 9 plus years, during which time we have achieved rapid growth in both our company and our business, while helping to save the lives of patients around the world. It has been an exciting and personally fulfilling journey, made more enjoyable by the positive chemistry and culture of our management team and employee base, which is a major reason why I have postponed my retirement for so long. But I am pleased to have been a major contributor, and look back on the accomplishments of my talented and highly capable finance and accounting teams in both the U.S. and Europe with pride. I believe the Company has an exciting future ahead, and look forward to an anticipated return to sales growth and the achievement of our first U.S. FDA marketing approval. Although I will retire formally at the end of March next year, I intend to continue supporting the Company from the sidelines as both a long-term shareholder and as a consultant as needed."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Kathy is an outstanding CFO and member of our leadership team, and we are extremely fortunate to have her. Among Kathy's many accomplishments, she was instrumental in our successful up-listing to Nasdaq. As CFO of a public company, Kathy has also been responsible for timely and consistent accounting, SEC reporting, and Sarbanes Oxley compliance, and has worked diligently to design and strengthen our system of internal controls. Kathy was also key in the capitalization of our company by supporting numerous successful fund raisings in cumulative excess of $140 million and establishing a favorable debt facility, enabling us to finance the global expansion of our business to 75 countries and to build a state-of-the-art manufacturing facility. Through maintenance of a strong network of investors, bankers, and analysts, and presentations and investor meetings at numerous conferences, Kathy supports analyst coverage from six investment banks, and has been a welcomed partner in our investor relations outreach. Meanwhile, she has developed, mentored, and led an outstanding group of finance and accounting professionals who expertly manage a broad and complex range of international trade and accounting issues, from consolidation of subsidiary results based in different currencies, to international tax policies. Lastly, Kathy has overseen the modernization of our finance and accounting information technology systems to support our growing needs."
"We are also very proud of Kathy's well-deserved accomplishments outside of the Company. Kathy was the 2016 NJ BIZ Magazine's Public Company CFO of the Year, currently serves as Chapter President and Member of the Board of Directors of the Mercer Chapter of the New Jersey Society of Certified Public Accountants (NJCPA), and was the recipient of the 2021 NJCPA Ovation Award recognizing CPAs who have had an impact on their jobs, communities, and the accounting profession."
Dr. Chan concluded, "Above all, Kathy has been a tremendous pleasure to work with as a trusted colleague who embodies the values of our Company as a positive, kind, committed, and generous leader who puts our people and our mission ahead of herself. We feel honored to cap her outstanding financial executive career in successful private and public companies, and will miss her greatly. On behalf of the entire Company and our Board of Directors, we thank Kathy for her many years of dedication and service to the Company and wish her all the best in retirement and in this next phase in her life."
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 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 June 30, 2022, more than 179,000 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 extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending 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 has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
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 https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-announces-pending-retirement-of-chief-financial-officer-kathleen-p-bloch-301643417.html
SOURCE CytoSorbents Corporation
8-K just filed, "retire from her role as CFO" Kathleen Bloch.
On September 30, 2022, Ms. Kathleen P. Bloch notified CytoSorbents Corporation (the “Company”) and the Board of Directors (the “Board”) of her decision to retire from her role as Chief Financial Officer of the Company, effective as of March 31, 2023. Ms. Bloch and the Company currently expect to enter into a consulting arrangement under which Ms. Bloch will continue to provide services to the Company in a limited capacity following the effective date of her retirement. Ms. Bloch has also agreed to assist the Company during its transition to a replacement Chief Financial Officer. On October 7, 2022, prior to market open, the Company intends to formally issue a press release announcing Ms. Bloch's retirement, a copy of which is included as Exhibit 99.1 hereto.
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/89242335/current-report-filing-8-k
CytoSorbents Awarded an Approximately $4.3M Contract by the U.S. Department of Defense to Develop HemoDefend-BGA™ for Freeze-Dried Universal Plasma
October 06 2022 - 07:00AM
PR Newswire (US)
PRINCETON, N.J., Oct. 6, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the U.S. Army Medical Research Acquisition Activity (USAMRAA) has awarded the Company a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
Dr. Maryann Gruda, PhD, Principal Investigator and Senior Director of Biology at CytoSorbents stated, "We are excited to begin this phase of our development program. The continued support and funding of our anti-A and anti-B blood group antibody (BGA) reduction technology by the Defense Health Agency and U.S. Army will be instrumental in bringing this technology to market. This award will fund the development and scale-up of a specialized HemoDefend-BGA filter that can be integrated with freeze-dried plasma technologies to generate a logistically superior, low titer plasma product that can be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Freeze-dried plasma is dry and lightweight, stable for up to 2 years at room temperature, and can be quickly reconstituted with sterile water when needed. However, it currently remains a blood-type specific product, complicating its use. HemoDefend-BGA can remove blood-type specific antibodies from single donor or pooled plasma prior to freeze-drying, with the goal of ultimately producing a 'one-size-fits-all' freeze-dried universal plasma – a major advance. Such a product would also eliminate the need for cold-chain storage – greatly simplifying battlefield logistics and enabling first responders to provide mobile/remote emergency resuscitation in civilian trauma."
The HemoDefend-BGA filter is not yet approved in the U.S. or elsewhere. This award was supported by the Defense Health Agency (DHA) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs/Joint Warfighter Medical Research Program (JWMRP) under U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract No. W81XWH-22-C-0046. The award is entitled "Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use." The outcome of this award is expected to be the large-scale manufacturing of the active polymer for subsequent integration of the device into the plasma freeze-drying process.
The content of this press release is solely the responsibility of the authors and any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of Defense, DHA, SBIR/STTR Programs, JWMRP, or USAMRAA.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/89237498/cytosorbents-awarded-an-approximately-4-3m-contra
Because we have an academic/MD for a CEO. Two different cultures.
This kid was a mess. That the CTSO filter contributed to saving him is amazing. Why can't we sell these filters?
Case of the Week
Literature Database
Intraoperative use of CytoSorb in a mitral valve replacement redo procedure due to infective endocarditis
Darío Andrade1, David Orozco-Vinasco2 | 1Department of Cardiac Surgery, Clínica Colsubsidio Calle 100, Bogota, Colombia | 2Department of Cardiovascular Anesthesia, Clínica Colsubsidio Calle 100, Bogota, Colombia
10/05/2022
Reduction in catecholaminesAnticoagulation HeparinCardiac surgeryCase of the weekCase reportCPBEndocarditisInflammatory parametersIntra-Op
Download documentDownload document
Summary
CoW 34/2021 – This case reports on a 18-year-old male patient, who was admitted to a secondary hospital due to febrile symptoms (38.5-39°C) and headache with deterioration of his neurological status (bradypsychia, deviation of gaze and vomiting) after outpatient antibiotic management following suspected neuro-infection.
Case presentation
Known medical history included Marfan syndrome, bacterial endocarditis at the age of 16 as well as mitral valve replacement with a mechanical prosthesis 8 months before the current hospitalization
Antibiotic therapy at this time point consisted of vancomycin (870 mg every 12 hours), rifampicin (300 mg every 8 hours) and gentamicin (60 mg iv every 8 hours)
Following admission, he was evaluated and after diagnostic brain CT imaging and laboratory analysis, initial working diagnosis was either endocarditis and/or septic embolism in the brain
Due to his medical history, he was then referred to the Clínica Colsubsidio Calle 100, Bogota, being a tertiary referral centre
Subsequent transesophageal echocardiography showed preserved contractility and systolic function, with a left ventricular ejection fraction (LVEF) of 58%, mechanical prosthesis in mitral position with elevated transvalvular gradients, echo-dense mass described in anterior portion of prosthetic ring compatible with a vegetation, and at least moderate anterior paravalvular leak
Over the following 4 days, the patient was evaluated for potential surgical treatment. However, due to the unknown etiology of his cerebrovascular event, additional studies were performed including checks for potential infectious diseases (e.g. COVID-19), and more advanced laboratory tests
Contrast magnetic resonance imaging (MRI) then confirmed an ischemic event in the late subacute evolutionary phase of probable embologenic etiology (septic) being the most likely cause, however micro-abscesses were also considered as differential diagnosis
Four days later, further neurological examinations reconfirmed an ischemic acute cerebrovascular event without hemorrhagic transformation and micro-abscesses. The antimicrobial management was deemed appropriate and was proposed to be continued for at least 4 weeks
Prior to surgery, the patient showed profound hemodynamic instability with a decreased systemic vascular resistance index (SVRI, 620 dyn*s*cm5*m²) requiring massive doses of vasopressors (vasopressin 3 IU/h, norepinephrine 0.5 µg/kg/min)
Additionally, hemodynamic disturbances translated into profound lactic acidosis (4.4 mmol/l)
As there were no contraindications for surgery nor for the use of anticoagulants, the redo procedure was scheduled for the next day and consisted of mitral valve replacement (MVR) with a mechanical prosthesis and tricuspid annuloplasty
Given the young age of the patient, his extensive medical history, the infectious profile as well as the hemodynamic instability, a CytoSorb hemoadsorber was integrated into the cardiopulmonary bypass (CPB) circuit with the rationale to stabilize hemodynamics and to reduce the hyperinflammatory response, which was anticipated would be triggered by this major procedure in a patient with considerable cardiac history
Treatment
CytoSorb was used in conjunction with the cardiopulmonary bypass machine (SARNS 8.000, Terumo. Additionally BP-80 Centrifugal pump, Medtronic) for a period of 100 minutes, cross clamp time was 90 min
Anticoagulation: heparin
Blood flow rate: 500 ml/min
ACT: 418 – 527 – 483 – 144 sec
Total heparin: 32,500 IU
Protamine: 30,000 IU
Ultrafiltration rate: 2.200 cc
Administered blood components during surgery: 2x fresh frozen plasma, 6x cryoprecipitate, 1x red blood cell concentrate
Measurements
Hemodynamics and catecholamine requirements
Lactate values
Inflammatory parameters
Postoperative bleeding rate
Results
Perioperatively, his vasopressor demand increased transiently and dobutamine had to be added. However, already 60 minutes after completion of the procedure, dosages of vasopressors could be decreased considerably (vasopressin 1 IU/h, norepinephrine: 0.05 µg/kg/min). Six hours after the procedure, vasopressin and norepinephrine infusion could be stopped and dobutamine was kept at 2.5 µg/kg/min to support contractility
This was accompanied by a decrease in plasma lactate concentrations from 4 mmol/l pre-treatment to 2.9 mmol/l during CPB and 2.5 mmol/l post CPB
Also levels of C-reactive protein (CRP) decreased under CytoSorb therapy: CRP pre 77 mg/l, CRP during CPB 3.3 mg/l, CRP post CPB 2.8 mg/l
Patient Follow-Up
Extubation 12 hours after leaving the operating theatre
Clinical evidence of good peripheral perfusion
No bleeding complications occurred and surgical drains were removed after 48 hours
Examination of valve cultures later confirmed colonization with S. hominis so it was decided to maintain antibiotic treatment with vancomycin for another 6 weeks
The patient developed a complete AV block postoperatively, and the electrophysiology department opted for permanent pacemaker implantation, while neurology recommended continuation of treatment initially in the intensive care unit
Transfer of the patient to the normal ward 6 days after the procedure and back home 9 days later with continued antibiotic and anticoagulation therapy
Conclusion
The intraoperative use of CytoSorb incorporated into the CPB circuit in this patient with infective endocarditis undergoing a mitral valve replacement redo procedure was associated with an improvement of the perioperative hemodynamic situation accompanied by resolution of lactic acidosis and control of the anticipated hyperinflammatory response
Due to the excellent results both in modulation of the inflammatory response and in the postoperative bleeding rate, the surgical team now routinely consider the intraoperative use of CytoSorb in patients with a diagnosis of infective endocarditis
Integration into the CPB circuit was easy and safe. No adverse events were recorded.
Google this guy Sean Lee. His record and rating is atrocious. I wish it wasn't so, but it is. But don't take my word for it. Check yourself.
H.C. Wainwright Reaffirms Their Buy Rating on Cytosorbents (CTSO)
September 28 2022 - 06:25AM
TipRanks
H.C. Wainwright analyst Sean Lee CFA maintained a Buy rating on Cytosorbents ( – ) today and set a price target of $9.00. The company’s shares closed yesterday at $1.39.
Lee CFA covers the Healthcare sector, focusing on stocks such as Plus Therapeutics, Verastem, and Cytosorbents. According to , Lee CFA has an average return of -22.9% and a 16.49% success rate on recommended stocks.
Currently, the analyst consensus on Cytosorbents is a Moderate Buy with an average price target of $16.00.
CTSO market cap is currently $60.57M and has a P/E ratio of -1.70.
TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which are most likely to make moves following their insider activities.
CytoSorbents Corp. engages in the research and development of blood purification technology for the reduction of deadly uncontrolled inflammation in hospitalized patients. Its product include CytoSorb, ContrastSorb, HemoDefend, VetResQ, and DrugSorb. The company was founded by Joseph Rubin on April 25, 2002 and is headquartered in Monmouth Junction, NJ.
tipranks
TipRanks is a comprehensive investing tool that allows private investors and day traders to see the measured performance of anyone who provides financial advice.
https://www.tipranks.com/news/blurbs/h-c-wainwright-reaffirms-their-buy-rating-on-cytosorbents-ctso?utm_source=advfn.com&utm_medium=referral
My Cousin Vinny quoted in the PR! How about that!?!(Mel Allen). Vinny, ignore all those posts calling you inept, incompetent, a fool etc. You're worth every penny of that $1.7 million package. Useless clown.
NEWS -- CytoSorbents Achieves ISO 13485 Certification of Princeton Manufacturing Facility in New Jersey
PRINCETON, N.J., Sept. 27, 2022 /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, announced today that it has received ISO 13485 Certification of its new manufacturing facility in Princeton, New Jersey from its European Union (E.U.) notified body, clearing the way for full manufacturing of CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® from this site, with capacity to add additional product lines as they are developed.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "We are very excited to receive this certification, which represents another key milestone in our company development and commercialization story. Our manufacturing, engineering, quality, and regulatory teams deserve the credit for this significant accomplishment. This state-of-the-art facility expands our manufacturing capacity to support up to $350-400 million in sales of our commercialized products, and will be a key component in the regulatory application and expected commercial launch of DrugSorb-ATR in the United States."
CytoSorb is an advanced blood purification cartridge approved in the E.U. and distributed in 75 countries worldwide to remove cytokines (inflammation), bilirubin (liver failure), and myoglobin (trauma), from blood. CytoSorb is also E.U. approved to remove the antithrombotic "blood thinning" drugs, Brilinta® (ticagrelor, Astra Zeneca) and Xarelto® (rivaroxaban, Janssen, Bayer) during cardiothoracic surgery to reduce the risk of perioperative bleeding.
DrugSorb-ATR is an investigational blood purification cartridge that uses an equivalent polymer technology to CytoSorb, and is in two pivotal U.S. randomized, controlled clinical trials under dual FDA Breakthrough Device Designations, to remove Brilinta® (STAR-T; Safe and Timely Antithrombotic Removal – Ticagrelor) and the direct oral anticoagulants (DOACs), Eliquis® (apixaban, Pfizer, BMS) and Xarelto® (STAR-D, - DOAC), intraoperatively during cardiothoracic surgery to reduce the risk of perioperative bleeding with the goal of achieving FDA marketing approval. The STAR-T trial is enrolling well and is expected to reach the first milestone with 40 patients enrolled within the next couple of months that will trigger the first Data and Safety Monitoring Board (DSMB) meeting.
ECOS-300CY® is approved in the E.U. as a cytokine adsorber for ex vivo organ perfusion machines used in solid organ transplant to reduce circulating cytokines and other inflammatory mediators. The goal of the therapy is to improve the functioning of substandard organs, potentially increasing the pool of donated organs and reduce the waiting list for transplant.
ISO 13485 was written to support medical device manufacturers in designing a quality management system (QMS) that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery through to disposal of medical devices that are safe for their intended purpose.
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 70 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 June 30, 2022, more than 179,000 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 extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending 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 has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the 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 and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, 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 https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Investor Relations Contact:
Amy Vogel
(732) 398-5394
mailto://avogel@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-achieves-iso-13485-certification-of-princeton-manufacturing-facility-in-new-jersey-301634177.html
SOURCE CytoSorbents Corporation
Less than 0.05 cents presplit!
Any cheerleaders with pom poms “backing up the truck” to take advantage of the outstanding opportunity today’s yearly low is providing? Oh, and before you accuse me of being a short, all I can say is “I wish!”
CEO just made a sizable insider buy of 35k shares on the open market, and now exceeds 4% ownership:
https://www.sec.gov/Archives/edgar/data/1175151/000110465922099104/xslF345X03/tm2225533-1_4seq1.xml
The U.S. Department of Defense Awards CytoSorbents an Approximately $2.0M Contract to Support HemoDefend-BGA™ Development for Life-saving Universal Plasma
PRINCETON, N.J., September 9, 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 today that the U.S. Army Medical Research Acquisition Activity, with funding from the Combat Casualty Care Research Program, awarded the Company a two-year grant (W81XWH-22-1-0235) valued at $1,977,024 to optimize development of the HemoDefend-BGA™ adsorber to a fully-finished, commercial device that will be evaluated in a pre-clinical porcine study for safety and efficacy. This Combat Casualty Care Research Program-funded research is a direct follow on to earlier development work funded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs.
The HemoDefend-BGA adsorber can rapidly remove >99% of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
Dr. Maryann Gruda, Principal Investigator and Senior Director of Biology at CytoSorbents stated, “This funding from the U.S. Army will be used to complete the development of our anti-A and anti-B blood group antibody reduction technology. Through prior awards, we have worked to optimize the efficiency, robustness, and form factor of our HemoDefend-BGA adsorber, and look forward to taking what we believe is a transformative technology into large animal testing, where we will evaluate the safety and efficacy of universal plasma generated by HemoDefend-BGA. We are excited to begin this portion of the development program.”
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents indicated, “Our HemoDefend-BGA program has the potential to address a global need for universal plasma in both civilian and combat casualty care. This priority initiative continues to advance, benefitting from more than $11M in government contracts. Once the pre-clinical study and requisite benchtop testing are successfully completed, we plan to file a U.S. FDA pre-submission package to pursue human clinical trials with the goal of bringing this life-saving technology to the market.”
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This award was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the U.S. Department of Defense (DoD), through the DoD Defense Health Program (DHP), Congressionally Directed Medical Research Programs (CDMRP), Defense Medical Research and Development Program, Joint Program Committee 6 Combat Casualty Care Research Program (CCCRP/JPC-6), Battlefield Resuscitation for Immediate Stabilization of Combat Casualties (BRISCC), in the amount of $1,977,024 under Award No. W81XWH-22-1-0235. The award is expected to optimize development of the HemoDefend-BGA adsorber via a preclinical animal study to evaluate safety and efficacy entitled “Demonstration of the Safety and Efficacy of Field-Ready Blood Group Antibody (BGA) Adsorber in a Porcine Universal Transfusion Model.” The content of this press release is solely the responsibility of the authors and any opinions, interpretations, conclusions, or recommendations expressed in this material are those of the author(s) and are not necessarily endorsed by the Department of Defense.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 179,000 cumulative CytoSorb devices have been utilized as of June 30, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind 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 has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $41.5 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.
Another news link on this is here:
https://markets.businessinsider.com/news/stocks/the-u-s-department-of-defense-awards-cytosorbents-an-approximately-2-0m-contract-to-support-hemodefend-bga-development-for-life-saving-universal-plasma-1031734352
The timeline, cost, and impact of those FDA approvals (assuming they happen) are the cause for concern. Market is pricing in serious dilution and my optimism that it can be avoided is waning fast. Best case we get an early positive result on STAR-T so we can raise money at higher stock price.
Bio, your optimism is admirable (and genuine I believe). I wish I could share it. I'm heavily invested, long, here. There is nothing indicating that the trials are proceeding timely. I posted at much higher prices that they should have sold the company. But why would these clowns do that while they suck the company dry? If panic hasn't set in at the headquarters IT SHOULD. We are in deep sh@t. Peace to you and good luck to us.
fantomphan, the ship has a rudder and is steering for 2 FDA approvals. You should get onboard.
This is a rudderless ship with these incompetents running things. Runaway spending like we're a successful company. So badly mismanaged.
Case report: Cytokine hemoadsorption in a case of hemophagocytic lymphohistiocytosis secondary to extranodal NK/T-cell lymphoma
Juan Carlos Ruiz-Rodríguez et al. Front Med (Lausanne). 2022.
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Front Med (Lausanne)
. 2022 Aug 15;9:925751.
doi: 10.3389/fmed.2022.925751. eCollection 2022.
Authors
Juan Carlos Ruiz-Rodríguez 1 2 3 , Luis Chiscano-Camón 1 2 3 , Adolf Ruiz-Sanmartin 1 2 3 , Clara Palmada 1 2 , Ivan Bajaña 1 2 , Gloria Iacoboni 3 4 , Camilo Bonilla 1 2 , Alejandra García-Roche 1 2 , Erika Paola Plata-Menchaca 1 2 3 , Carolina Maldonado 1 2 , Marcos Pérez-Carrasco 1 2 3 , Mónica Martinez-Gallo 3 5 6 7 , Clara Franco-Jarava 5 6 , Manuel Hernández-González 5 6 7 , Ricard Ferrer 1 2 3
Affiliations
1 Intensive Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
2 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d'Hebron Research Institute (VHIR), Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
3 Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.
4 Hematology Department, Vall d'Hebron Hospital Universitari, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
5 Immunology Division, Vall d'Hebron University Hospital, Barcelona, Spain.
6 Diagnostic Immunology Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.
7 Department of Cell Biology, Physiology and Immunology, Autonomous University of Barcelona (UAB), Barcelona, Spain.
PMID: 36045925
PMCID: PMC9423101
DOI: 10.3389/fmed.2022.925751
Cite
Abstract
We discuss a single case of Hemophagocytic lymphohistiocytosis (HLH) due to NK-type non-Hodgkin lymphoma and Epstein-Barr virus reactivation with multiorgan dysfunction and distributive shock in which we performed cytokine hemoadsorption with Cytosorb ®. A full microbiological panel was carried out, including screening for imported disease, standard serologies and cultures for bacterial and fungal infection. A liver biopsy and bone marrow aspirate were performed, confirming the diagnosis. The patients fulfilled the HLH-2004 diagnostic criteria, and according to the 2018 Consensus Statements by the HLH Steering Committee of the Histiocyte Society, dexamethasone and etoposide were started. There was an associated hypercytokinemia and, due to refractory distributive shock, rescue therapy with cytokine hemoadsorption was performed during 24 h (within day 2 and 3 from ICU admission). After starting this procedure, rapid hemodynamic control was achieved with a significant reduction in vasopressor support requirements. This case report highlights that cytokine hemoadsorption can be an effective since rapid decrease in IL-10 levels and a significant hemodynamic improvement was achieved.
New on PubMed
Use of Cytokine Filters During Cardiopulmonary Bypass: Systematic Review and Meta-Analysis
Vinci Naruka et al. Heart Lung Circ. 2022.
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Heart Lung Circ
. 2022 Aug 27;S1443-9506(22)01038-1.
doi: 10.1016/j.hlc.2022.07.015. Online ahead of print.
Authors
Vinci Naruka 1 , Mohammad Yousuf Salmasi 2 , Arian Arjomandi Rad 2 , Nandor Marczin 2 , George Lazopoulos 3 , Marco Moscarelli 2 , Roberto Casula 4 , Thanos Athanasiou 5
Affiliations
1 Department of Surgery and Cancer, Imperial College, London, UK; Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK.
2 Department of Surgery and Cancer, Imperial College, London, UK.
3 Department of Cardiothoracic Surgery, University Hospital of Heraklion, Crete, Greece.
4 Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK.
5 Department of Surgery and Cancer, Imperial College, London, UK; Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK. Electronic address: t.athanasiou@imperial.ac.uk.
PMID: 36041987
DOI: 10.1016/j.hlc.2022.07.015
Cite
Abstract
Introduction: Cardiac surgery involving cardiopulmonary bypass (CPB) activates an inflammatory response releasing cytokines that are associated with less favourable outcomes. This study aims to compare i) CPB during cardiac surgery (control) versus ii) CPB with haemoadsorption therapy; and assess the effect of adding this therapy in reducing the inflammatory cytokines burden.
Methods: A systematic literature review with metanalysis was conducted regarding the main outcomes (operative mortality, ventilation duration, intensive care unit [ICU] and hospital stays) and day-1 inflammatory markers levels post-surgery. Fifteen (15) studies were included for final analysis (eight randomised controlled trials, seven observational studies) with no evidence of publication bias.
Results: Subgroup analysis of non-elective surgeries across observational studies (emergency and infective endocarditis) significantly favoured cytokine filters in terms of 30-day mortality (OR 0.40, 95% CI 0.20, 0.83; p=0.01) and shorter ICU stay (MD -42.36, 95% CI -68.07, -16.65; p=0.001). At day-1 post-surgery, there was a significant difference favouring the cytokine filter group in c-reactive protein (CRP) (MD -0.71, 95% CI -0.84, -0.59; p<0.001) with no differences in white blood count (WBC), procalcitonin (PCT), tumour necrosis factor-alpha (TNF-a), IL-6, IL-8 and lactate. When comparing cytokine filters and control across all studies there was no significant difference in operative mortality, ventilation duration, hospital stay and ICU length of stay. Also, there were no statistical differences in randomised controlled trials (RCTs) using haemadsorption filters.
Conclusions: A significant reduction in 30-day mortality and ICU stay could be obtained by using haemadsorption therapy during non-elective cardiac surgery, especially emergency surgery and in patients with higher inflammatory burden such as infective endocarditis.
Eskay, on 4/6/20 you posted what you said was your last post.
Put a fork in CTSO! It’s done!
PR Newswire
Turkish Ministry of Health Grants National Reimbursement to CytoSorb®
The cost of treatment with CytoSorb® will now be covered by the public sector in Turkey
PRINCETON, N.J., Aug. 23, 2022 /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, announced that the Turkish Ministry of Health has approved national reimbursement for CytoSorb®, which is now a reimbursed catalog product in the State Supply Office of Turkey (DMO) portal and can be purchased directly by hospitals and physicians without restrictions.
https://finance.yahoo.com/news/turkish-ministry-health-grants-national-110200872.html
Israeli Ministry of Health Approves National Coverage for CytoSorb®
Wed, August 17, 2022 at 7:02 AM
PRINCETON, N.J., Aug. 17, 2022 /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, announced that the Israeli Ministry of Health (MoH) has approved national reimbursement for CytoSorb® in certain cardiac surgery indications that is expected to take effect in 2023.
Israeli Ministry of Health Adds CytoSorb Blood Purification Cartridge to Healthcare Basket with National Reimbursement
https://finance.yahoo.com/news/israeli-ministry-health-approves-national-110200187.html
Case of the Week
Literature Database
The successful application of hemoadsorption for extracorporeal liver support in a child with acute liver failure
Wun Fung Hui, Wing Lum Cheung, Fung Shan Chung, Karen Ka Yan Leung and Shu Wing Ku | Department of Paediatrics and Adolescent Medicine, Hong Kong Children’s Hospital, Kowloon, Hong Kong | Int J Artif Organs 2022; epub
08/17/2022
New!PediatricsPeer Reviewed Published DataSafetyBilirubinCase of the weekCase reportCritical CareCRRT (pre or post filter)Improv. hep. encephalopathy
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Summary
CoW 33/2022 – This case reports on a 6-year-old boy, who was admitted to the hospital due to prolonged dyskinetic movements resulting in rhabdomyolysis and acute kidney injury.
Summary
The following case report describes the use of CytoSorb in a pediatric patient for the reduction of hyperbilirubinemia and elevated serum bile acids in acute liver failure. A 6-year-old boy was admitted to hospital due to prolonged dyskinetic movements resulting in rhabdomyolysis and acute kidney injury. Over the following 10 days he was given multiple antibiotics for various infections and five days later developed acute liver failure with hepatic coma due to drug rash with eosinophilia and systemic symptoms (DRESS). He had hyperbilirubinemia, elevated serum bile acids and hyperammonemia as well as raised liver enzymes. Despite standard therapies his condition deteriorated, and he was admitted to the Pediatric Intensive Care Unit (PICU) for ongoing management. In addition to the use of systemic steroids and other supportive therapies, he was started on continuous renal replacement therapy (CRRT), into which a CytoSorb column was added as an extracorporeal liver support to try and reduce the bilirubin and bile acids. Three adsorbers were used for a total duration of 75 hrs (28, 22 and 25 hrs). Serum levels of total bilirubin reduced from 418 to 119 µmol/L, bile acids to from 174 to 58 µmol/L and ammonia reduced from 172 to 55 µmol/L. His conscious level gradually improved, as did his liver function. Except for mild, non-symptomatic thrombocytopenia and mild electrolyte disturbances, the therapy was well tolerated with no major complication encountered. He was finally able to be discharged from the PICU after 20 days. The authors state that hemoadsorption may have the merits of a faster initial rate of bilirubin removal and ease of set up compared to albumin dialysis. In summary this case demonstrates that hemoadsorption with CytoSorb can be safely employed as an adjunctive extracorporeal liver support modality in children with acute liver failure as it can efficiently remove bilirubin and bile acids. The potential role and technical concerns of applying such technique in pediatric patients requires further evaluation in future studies.
Case presentation
He was initially given ceftriaxone for potential central venous system infection. Later, his course was complicated by streptococcus mitis pneumonia resulting in the administration of vancomycin for 7 days. In the subsequent 10 days of hospitalization, he was given amoxicillin and clavulanic acid as well as piperacillin/tazobactam as empirical therapy for recurrence of fever, while all microbiological investigations showed no positive bacterial growth
Five days after stopping all antibiotics, he again developed low grade fever. He also had hepatomegaly, ascites and a generalized erythematous maculopapular rash associated with tender cervical lymphadenopathy
Blood tests revealed leukocytosis with white blood cell count 12.4×109/L, lymphocyte count 4.72×109/L, eosinophil count 0.37 × 109/L, and the presence of atypical lymphocytes
He also showed increased liver enzymes (serum levels of alanine aminotransferase [ALT] 1241 IU/L, alkaline phosphatase [ALP] 220 IU/L, aspartate aminotransferase [AST] 839 IU/L and gamma-glutamyl transferase [GGT] 160 IU/L), hypoalbuminemia (29 g/L), hyperbilirubinemia (25 µmol/L), and coagulopathy (international normalized ratio [INR] 1.49 and activated partial thromboplastin time [aPTT] 34.6 s). The ammonia level was <20 µmol/L
Ultrasound of the hepatobiliary system showed no focal hepatic lesions and no dilated biliary system
He was started on cefotaxime empirically, which was changed to meropenem 4 days later
Supportive treatment with vitamin K, albumin and fresh frozen plasma (FFP) was also commenced
However, serial investigations revealed evolving hepatic failure and he was subsequently transferred to the Pediatric Intensive Care Unit (PICU) for further management
Upon PICU admission, he was still arousable and his Glasgow Coma Scale (GCS) was 15, but he soon started to desaturate requiring high flow oxygen of 15 L/min
Multiple investigations were performed to try and determine the underlying cause of his acute hepatic failure. Finally, he was diagnosed with drug rash with eosinophilia and systemic symptoms (DRESS) syndrome (most probably due to previous exposure to multiple antibiotics, in particularly the beta-lactams) based on the RegiSCAR (Registry of Severe Cutaneous Adverse Reaction) criteria, with Wilson’s disease being an important differential diagnosis
Hence, all antibiotics were stopped after PICU admission
He was then given ursodeoxycholic acid and vitamin supplements for his cholestasis and lactulose to limit enteral ammonia absorption. His protein intake was limited to <1 g/kg/day
One dose of intravenous immunoglobulin was administered for potential Epstein-Barr virus infection
Methylprednisolone was also started 3 days after admission as a treatment for DRESS syndrome
Despite that, he continued to deteriorate with reduced conscious level (GCS dropped to 10) suggesting the development of grade three hepatic encephalopathy. Serum total bilirubin was 418 µmol/L, direct bilirubin 328 µmol/L, bile acids 174 µmol/L and ammonia levels had increased to 172 µmol/L, while INR increased to 3.12
There was also evolving bradycardia suggestive of bile acid-associated cardiac toxicity. The bedside echocardiogram showed normal contractility with a left ventricular fractional shortening of 37%
His highest Pediatric End-stage Liver Disease (PELD) score was 30 and he had a work up for potential liver transplant
Therefore, continuous renal replacement therapy (CRRT) was started for hyperammonemia 4 days after admission. In order to accelerate removal of bilirubin and bile acids, a CytoSorb hemoadsorption column was additionally integrated into the CRRT circuit
Treatment
Three adsorbers were used for a total duration of 75 hrs (28, 22 and 25 hrs)
Measurements
Bilirubin, bile acids, ammonia
Liver function
Level of consciousness
Coagulation profile
Platelets, electrolytes
Results
Under combined CRRT+CytoSorb treatment, serum levels of total bilirubin reduced from 418 to 119 µmol/L, bile acids to from 174 to 58 µmol/L and ammonia reduced from 172 to 55 µmol/L
His liver function showed gradual improvement following therapy initiation. Of note, one day after commencing combined CRRT+CytoSorb he was started on penicillamine based on the provisional diagnosis of Wilson’s Disease
His conscious level also improved and returned to his baseline level 2 days after CRRT+CytoSorb initiation
The coagulation profile improved and there was reduced requirement for FFP infusion
Except for mild, non-symptomatic thrombocytopenia and mild electrolyte disturbances, the therapy was well tolerated with no major complications encountered
Patient Follow-up
One dose of carglumic acid and regular sodium benzoate were started as a bridging therapy to prevent rebound of hyperammonemia upon CRRT termination
Sodium benzoate administration was stopped one week after CRRT termination
A drug challenge test was arranged and blood tests on day 20 of PICU admission showed serum levels of ammonia 37 µmol/L, total bilirubin 102 µmol/L, ALT 91 IU/L, ALP 170 IU/L, AST 43 IU/L, GGT 208 IU/L, INR was 0.95
He was finally discharged from the PICU 20 days after admission
Conclusion
In summary, this case demonstrates that hemoadsorption with CytoSorb can be safely employed as an adjunctive extracorporeal liver support modality in children with acute liver failure as it can efficiently remove bilirubin and bile acids
The authors state that hemoadsorption may have the advantages of a faster initial rate of bilirubin removal and ease of set up compared to albumin dialysis
The potential role of applying such technique in pediatric patients requires further evaluation in future studies.
Management of perioperative bleeding risk in patients on antithrombotic medications undergoing cardiac surgery – a systematic review
Matejic-Spasic M, Hassan K, Thielmann M, Geidel S, Storey RF, Schmoeckel M, Adamson H, Deliargyris EN, Wendt D. J Thorac Disease 2022; epub
08/2022
The aim of this review was to evaluate perioperative bleeding complications in patients on dual antiplatelet therapy (DAPT) or direct-acting oral anticoagulants (DOACs) undergoing high-bleeding risk cardiovascular surgery and to present currently available potential solutions to mitigate antithrombotic therapy-related bleeding complications. Relevant articles on bleeding complications in cardiac surgery from last 10 years in Medline (PubMed) were screened. An additional search evaluating potential solutions to mitigate bleeding complications was also performed. From all reviewed studies, a total of 19 articles could be included evaluating the risk for bleeding in cardiac surgery related to DAPT or DOACs, and 10 papers evaluating antithrombotic drug reversal or removal in this setting. Reported bleeding rates ranged between 18% and 41%, a remarkably wide variability. New costly reversal agents are available but have not been sufficiently tested in this setting. Antithrombotic removal by innovative intraoperative hemoadsorption has been shown to be associated with a significant decrease in re-thoracotomy rate, overall procedure duration, administered transfusion volumes, chest-tube drainage, and length of hospitalization. Results from ongoing trials should provide more informed insights concerning the efficacy and safety of several potential solutions.
Looks like they gave themselves shares, of course due to the fabulous job they've done, and the cowards release the info on a Friday night as well.
You didn't answer the question or respond to any of the points I brought up. Just wondering if you listened to the call or not and what your thoughts were concerning the points that were discussed in this call?
"There is too a Great Pumpkin. You'll see!"
Did anyone actually listen to the 2nd quarter earnings report. I think the reasons given for the reduced quarterly earnings were very much out of management hands and should be improving greatly over the next quarter or two. Also, there is a marked increase in the number of publications showing positive results that are being put out with quite a few more being published in the coming months. In addition, the START-T & START-D Trials should really be ramping up over the next quarter since both have over 20 sites now recruiting with a lot of synergies between the two studies.
I know it's been a long time coming but I can certainly wait another quarter or two before I start badmouthing management. I'd like to see some other comments concerning this call and get other people's opinion.
Case of the Week
Literature Database
Hemoadsorption for severe MIS-C in critically ill children, should we consider it as a therapeutic opportunity?
Gabriella Bottari1, Flavia Severini2, Anna Hermine Markowich2, Giulia Lorenzetti2, Juan Carlos Ruiz Rodriguez3,4, Ricard Ferrer3,4, Paola Francalanci5, Antonio Ammirati6, Paolo Palma7 and Corrado Cecchetti1 |1 Pediatric Intensive Care Unit, Pediatric Emergency Department, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 2 Department of Pediatrics, University of Rome Tor Vergata, Residency School of Pediatrics, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 3 Intensive Care Department, Vall d’Hebron University Hospital, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain | 4 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d’Hebron Research, Institute (VHIR), Barcelona, Spain | 5 Unit of Pathology, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 6 Pediatric Emergency Unit, Pediatric Emergency Department, Bambino Gesù Children’s Hospital, IRCSS, Rome, Italy Int J Artif Organs 2022; epub
08/10/2022
New!PediatricsPeer Reviewed Published DataReduction in catecholaminesReviewSafetyViral infectionCase of the weekCase reportCOVID-19Critical CareCRRT (pre or post filter)Inflammatory parameters
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Summary
CoW 32/2022 – This case reports on a 13 year old boy (weight 60 kg, height 160 cm) who presented with fever, rash, abdominal pain, and vomiting.
Summary
Multisystem inflammatory syndrome (MIS-C) is a new severe clinical condition that has emerged during the COVID-19 pandemic and affects children and the young usually after a mild or asymptomatic COVID-19 infection. Symptoms commonly include cardiovascular dysfunction for which support is required in the majority of cases. In the case report a 13 yr old boy with refractory shock secondary to left ventricular dysfunction (LVD) in the context of MIS-C, the use of hemoadsorption with CytoSorb is described. The therapeutic strategy resulted in hemodynamic and clinical stabilization (reduction then cessation of vasopressors) as well as control of the hyperinflammatory response (including C-Reactive Protein, interleukin – IL-6 and IL-10). The patient received in total 5 adsorbers over 72 hrs. with the first 2 adsorbers for 12 hours each, and a further 3 adsorbers for 24 hours each inserted into the continuous renal replacement circuit. Treatment appeared to be safe and feasible. The authors then compare this case with two more published cases where CytoSorb has been used as an adjuvant therapy in similarly critically ill children with severe forms of MIS-C. All three patients responded with a prompt improvement in their myocardial function (within the first 24 h) following the start of hemadsorption. The authors state that using this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygenation (ECMO) and other mechanical cardiocirculatory supports, with the advantage of it being less invasive. They also state that CytoSorb does not appear to interfere with most common immunomodulatory therapies although further evidence is required.
Case presentation
Blood tests revealed elevated leukocytes with neutrophilia, high C-reactive protein (CRP) (29.31 mg/gL), procalcitonin (3.32 ng/mL), and hyperferritinemia (1529 ng/mL)
He had a positive history for SARS-CoV-2 infection 6 weeks previously with positive serology
Within 24 h he developed diarrhea, poor pallor, and hypotension
Cardiac markers were elevated, and 2D-echocardiogram showed left ventricular (LV) dysfunction (Ejection Fraction EF 35%)
Supportive care with milrinone and dopamine was started and, as multisystem inflammatory syndrome in children (MIS-C) was suspected, he received immunoglobulins and corticosteroids
The following day he deteriorated, with an 2D-echocardiogram showing a LVEF of 25%, therefore he was referred to the pediatric intensive care unit (PICU) requiring endotracheal intubation and invasive mechanical ventilation (IMV) due to cardiogenic shock
Given the increase in troponin I (high sensitivity troponin, hs-TnI) levels from 75 to 1200 pg/ml in 12 h, infectious myocarditis was suspected and an endomyocardial biopsy (EMB) was taken
Considering the clinical picture of hyperinflammation associated severe shock due to left ventricular dysfunction (LVD) and high lactate (7.9 mmol/l) with the need for high inotropic and vasopressor support (epinephrine 0.35 µ/kg/min, norepinephrine 0.06 µ/kg/min, and milrinone 0.5 µ/kg/min), hemoadsorption with CytoSorb was started in combination with continuous kidney replacement therapy (CKRT)
Of note, even though the patient fulfilled the diagnostic criteria of MIS-C, the authors could not completely rule out the development of fulminant myocarditis due to Parvovirus B19 (PVB19) positivity after suffering from COVID-19, which is why corticosteroids were withheld and immunoglobulins and anakinra were maintained
Treatment
The patient received in total 5 adsorbers over 72 hrs with the first 2 adsorbers for 12 hours each, and a further 3 adsorbers for 24 hours each inserted into the continuous renal replacement circuit
Anticoagulation protocol: citrate-calcium
Measurements
Hemodynamics and requirements for vasoactive substances
Inflammatory parameters
Left ventricular ejection fraction
Cardiac enzymes
Safety
Results
The therapeutic strategy resulted in hemodynamic stabilization with a rapid reduction followed by the cessation of vasopressors at the time of discontinuation of CytoSorb therapy
Treatment was also associated with control of the hyperinflammatory response as evidenced by a reduction in inflammatory parameters including CRP, interleukin – IL-6 and IL-10
After the first 24 h of combined hemoadsorption and CKRT therapy, an improvement in the LVEF to 50% was observed
Troponin I levels decreased from 1200 pg/ml to around 375 pg/ml within 12 hours of treatment with decreasing levels thereafter, reaching ~100 pg/ml by the end of blood purification therapy
No adverse events were noted
Patient Follow-up
CKRT was discontinued at the same time of hemoperfusion after 72 h (day 3)
He was weaned off invasive mechanical ventilation on day 6 and discharged from the PICU on day 8
After 2 weeks his cardiac function had completely restored and the patient was discharged from the hospital on day 20 requiring only the diuretic, spironolactone
Conclusion
In this adolescent with refractory shock secondary to LV dysfunction in the context of MIS-C, treatment with hemoadsorption in combination with immunomodulatory therapies resulted in hemodynamic and clinical stabilization as well as control of the hyperinflammatory response with the treatment appearing safe and feasible
The authors compare this case with two more published cases where CytoSorb has been used as an adjuvant therapy in similarly critically ill children with severe forms of MIS-C. All three patients responded with prompt improvements in their myocardial function (within the first 24 h) following the start of hemoadsorption
The authors state that using this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygenation (ECMO) and other mechanical cardiocirculatory supports, with the advantage of it being less invasive. They also state that CytoSorb does not appear to interfere with most common immunomodulatory therapies although further evidence is required.
Imagine this pile of crap company employing a CEO and a separate President! And why? And the useless President knocking down a total package of $1.7 MILLION. I'd say this is a joke but there isn't a damn thing funny anymore. We've reached critical mass with these buffoons.
I think I said it perfectly on this reply to a 2019 post I made here, it was spot on!
The warning signs have been here for years, the hit piece was absolutely correct, .075 presplit, sad, no future catalyst only bankruptcy eventually!
I've really tried to stay quiet but THEY SUCK. Inept, overmatched, incompetent. Disgraceful. When does somebody pay with their job? WHEN???
Extracorporeal hemoadsorption with the CytoSorb device as a potential therapeutic option in severe intoxications: Review of the rationale and current clinical experiences
Darko Mitrovic et al. J Clin Pharm Ther. 2022.
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J Clin Pharm Ther
. 2022 Aug 3.
doi: 10.1111/jcpt.13724. Online ahead of print.
Authors
Darko Mitrovic 1 , Daan W Huntjens 2 , Elisabeth A J de Vos 3 , Martijn van Tellingen 4 , Eric J F Franssen 2
Affiliations
1 Hospital Pharmacy, Tjongerschans Hospital Heerenveen, Heerenveen, The Netherlands.
2 Department of Clinical Pharmacy, OLVG Hospital, Amsterdam, The Netherlands.
3 Department of Intensive Care, OLVG Hospital, Amsterdam, The Netherlands.
4 Intensive Care, Tjongerschans Hospital Heerenveen, Heerenveen, The Netherlands.
PMID: 35924306
DOI: 10.1111/jcpt.13724
Cite
Abstract
What is known and objective: Many severe intoxications occur with substances with no specific antidote, which is why methods of extracorporeal elimination represent a particularly useful and even critical component in their management. The purpose of this review is to summarize the accumulating evidence and clinical results from the application of CytoSorb hemoadsorption therapy in patients with severe intoxications.
Comment: The technology represents a promising technique with an increasing number of publications in a variety of severe intoxication scenarios suggesting that early intervention might provide rapid substance removal with subsequent overall clinical improvement.
What is new and conclusion: Given the tremendous challenges in performing prospective, randomized trials in this field, the strong safety profile of the device and the high acuity of these life-threatening situations, CytoSorb should be considered as a therapeutic option in severe intoxications, particularly when direct antidotes are not available. However, further clinical data are desirable to provide precise recommendations.
Keywords: CytoSorb; blood purification; drug; hemoadsorption; intoxication.
Case of the Week
Literature Database
First Hemoadsorption during Cardiopulmonary Bypass in Neonate with Complex Cardiac Malformation
Christophel-Plathier E, Mendes V, Verdy F, Mauron S, Mury C. Annals of Clinical Case Reports 2022; 7:2257
08/03/2022
New!PediatricsPeer Reviewed Published DataReduction in catecholaminesReduction in length of staySafetyImprov. resp functionImpact on organ supportCardiac surgeryCase of the weekCase reportCPBInflammatory parametersIntra-Op
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Summary
CoW 31/2022 – This case reports on a 5 day old male full term newborn with congenital hypoplastic left heart syndrome who was scheduled for a corrective procedure.
Case presentation
His left heart syndrome involved an absent mitral valve and exceedingly small aortic annulus, ascending aorta and aortic arch. Perfusion of the aortic arch was retrograde through a persistent patent ductus arteriosus. Right ventricular systolic function was normal
Shortly after birth, the neonate required continuous positive airway pressure (CPAP) and then invasive ventilation with permissive hypercapnia
He received levosimendan 12 h before surgery, and maintenance with a prostaglandin E1 infusion
Five days after birth, the patient underwent a Norwood stage I palliation with interatrial septum resection, aortic arch reconstruction and the creation of a Blalock-Taussig shunt
Cardiopulmonary bypass (CPB) duration was 227 min, aortic cross-clamping duration 180 min. Selective cerebral perfusion was 27 min at a central core temperature of 27.8° Celsius
In order to reduce the pre-operative and intra-operative inflammatory process, a CytoSorb hemoadsorption device was pre-emptively integrated into the CPB circuit
Treatment
The CytoSorb cartridge was inserted between the oxygenator outlet (QUADROX-i neonatal HMO 11000® MAQUET) and the venous line, assisted by a roller pump slave to the blood pump
The minimum flow rate through the cartridge was 100 ml/min. The servo control was 14% of the patient’s theoretical flow, indexed to 3.0 l/min/m2 to compensate for the drop induced by CytoSorb and to ensure a flow rate of 2.4 l/min/m2 to the patient
Priming was performed using “ventilated reconstituted whole blood” to ensure homeostatic conditions at CPB initiation requiring 385 ml of blood, of which 120 ml were used for priming the CytoSorb
Measurements
Hemodynamics and requirements for vasoactive substances
Overall clinical course
Results
The patient returned to the intensive care unit (ICU) intubated with infusions of norepinephrine, dopamine and milrinone. Thereafter, hemodynamic adaptation was good, with rapid weaning off all amine infusions and definitive weaning off norepinephrine on post-operative day 5
Surgery was successful and correction was adequate, with unobstructed flow through the interatrial communication and inside the aortic arch, and with good ventricular function. Despite the severity of his condition, the baby had anuneventful post-operative course, without renal, digestive, or infectious complications
Patient Follow-up
The patient was extubated on post-operative day 6
He left the ICU on day 22 and was discharged home on day 45
Conclusion
The authors describe the clinical course post-operatively as remarkable with shortened ICU and hospital lengths of stay due to the lack of (anticipated) complications. They state that previous similar cases have required much longer support on ventilation and longer ICU stays. They also believe the expected benefits to the anti-inflammatory processes are worth the large homologous blood use
As the use of CytoSorb was the only differentiating factor, its use likely helped to reduce the pre-operative and intra-operative inflammatory process, and thereby helped with the positive clinical course and outcome. The authors conclude with stating that by reducing cytokine levels, CytoSorb may have significantly reduced catecholamine infusion time, intubation time, and ICU stay.
NEWS -- CytoSorb® Becomes a Featured Blood Purification Therapy on Fresenius Medical Care Critical Care Platforms
BAD HOMBURG V.D. HÖHE, GERMANY and PRINCETON, N.J., Aug. 2, 2022 /PRNewswire/ -- Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME) and CytoSorbents Corporation (NASDAQ: CTSO) have expanded their partnership by establishing a multi-stage global collaboration to combat life-threatening diseases in critical care for an initial term of three years. The new agreement provides for the combined marketing and promotion of CytoSorb® with Fresenius Medical Care's critical care products by Fresenius Medical Care's marketing organization worldwide, excluding the United States. Compared to the prior co-marketing agreement, this agreement increases the commitments from both parties and ensures an ongoing and consistent level of marketing and promotional activity specifically focused around CytoSorb, where Fresenius Medical Care will actively market and promote CytoSorb as the featured blood purification therapy for removal of cytokines, bilirubin, and myoglobin on its critical care platforms. Over the next three years, various Fresenius Medical Care-led in-person, virtual, social media, and web-based marketing programs and events will feature CytoSorb therapy and highlight the cooperation between the two companies in the field of critical care.
Fresenius Medical Care and CytoSorbents expand global marketing collaboration featuring CytoSorb
"As part of Fresenius Medical Care's commitment to providing our customers with leading solutions for their critical care patients, we are pleased to announce this new global collaboration with CytoSorbents," said Dr. Olaf Schermeier, CEO of Critical Care at Fresenius Medical Care. "With the ability to seamlessly integrate CytoSorb with our multiFiltratePRO acute dialysis platform that is routinely used throughout the world today, we have the opportunity to positively impact patient care for various life-threatening conditions such as sepsis, liver failure, trauma, lung injury, and many others."
Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents commented, "CytoSorb adds a powerful new dimension of blood purification to Fresenius Medical Care's critical care portfolio. It is specifically designed to reduce toxic levels of cytokines, bilirubin, and myoglobin that can lead to organ failure. The process is similar to hemodialysis, mastered by Fresenius Medical Care to treat kidney failure, which removes accumulated small to medium-sized, water-soluble molecules and toxins from the bloodstream. However, CytoSorb adds the ability to remove large molecules and toxins that are poorly removed by hemodialysis. Combined, the two therapies work together in a complementary manner to provide treatment for a broad range of conditions in the intensive care unit."
Dr. Steiner went on to highlight the importance of this collaboration stating, "Together with Fresenius Medical Care, we now have the ability to broadly and consistently communicate the benefits of CytoSorb therapy to customers throughout the world. In addition, it enables us to execute targeted marketing campaigns in collaboration with Fresenius Medical Care which will help to accelerate the introduction and adoption of CytoSorb. Overall, I believe this will be the starting point for further exciting developments on both the medical and business fronts."
Mr. Chris Cramer, Vice President of Business Development at CytoSorbents commented, "We are excited to expand our relationship with our long-standing partner, Fresenius Medical Care. This agreement promotes a stronger collaboration with Fresenius Medical Care's global commercial organization to more effectively bring our CytoSorb therapy to more customers around the world as a featured blood purification solution on Fresenius Medical Care's critical care platforms. We believe the synergy has the potential to create sustained and broader growth for both companies over time and is just the first of multiple opportunities to offer our combined critical care solutions."
In addition to strengthening and expanding the global marketing of CytoSorb, CytoSorbents and Fresenius Medical Care also plan to work together to bring new innovative solutions to the market. The agreement also includes the certification of compatibility between CytoSorb and Fresenius Medical Care's current critical care platforms. To help support the increased marketing and promotional efforts of the expanded collaboration, CytoSorbents has agreed to subsidize a portion of the marketing costs through a royalty payment to Fresenius Medical Care based on CytoSorb sales in the intensive care unit on Fresenius Medical Care platforms, excluding the United States.
About Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME)
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.8 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,163 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 346,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the Company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
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 70 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 June 30, 2022, more than 179,000 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 extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending 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 has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $39.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the 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 and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, 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 https://www.cytosorbents.com and https://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.
Contacts Fresenius Medical Care AG & Co. KGaA
Investor Relations:
Else-Kröner-Straße 1
61346 Bad Homburg
Germany
+49 (0) 6172 609-0
mailto://ir@fmc-ag.com
Contacts CytoSorbents Corp.
Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@cytosorbents.com
Public Relations Europe:
Marcus Schult
kommponisten
+49 69 13823 ext. 960
+49 172 4238938
mailto://marcus.schult@die-kommponisten.com
CytoSorbents Europe GmbH:
Josephine Kraus
PA by Dr. Christian Steiner
+49 30 765 84 66 23
mailto://josephine.kraus@cytosorbents.com
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SOURCE CytoSorbents Corporation; Fresenius Medical Care
CytoSorbents Reports Second Quarter 2022 Financial and Operational Results
PRINCETON, N.J., Aug. 2, 2022 /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, today reported unaudited financial and operating results for the quarter ended June 30, 2022.
Second Quarter 2022 Financial Results
Total Q2 2022 revenue, including product sales and grant income, was $8.5 million versus $12.0 million in Q2 2021, a decrease of 29%
Q2 2022 product sales were $7.3 million (negligible COVID-related sales) versus $11.4 million (includes $1.7 million in COVID-related sales) in Q2 2021. The decrease in the average Euro to U.S. dollar exchange rate lowered Q2 2022 product sales by approximately $840,000. On a constant currency basis, Q2 2022 core non-COVID sales would have been approximately $8.2 million, which represents a 15% decrease from approximately $9.7 million in core non-COVID sales a year ago, but comparable to the average currency adjusted core non-COVID sales over the prior three quarters
As expected, COVID-19 related sales during the quarter were negligible reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination and natural immunity
Product gross margins were approximately 67% in Q2 2022, versus 82% in Q2 2021. The decrease in the gross margin percentage was due primarily to manufacturing inefficiencies from a scheduled 4-week production hiatus as we relocated to our new production facility during the quarter
The Company maintains a healthy balance sheet with cash and cash equivalents of $31.9 million (which includes $1.7 million in restricted cash) as of June 30, 2022, and no debt
Recent Operating Highlights:
More than 179,000 cumulative CytoSorb devices have been utilized worldwide as of June 30, 2022, compared to more than 143,000 devices utilized cumulatively a year ago
Announced today the signing of an expanded global marketing agreement with Fresenius Medical Care where CytoSorb® will become a featured blood purification therapy on Fresenius Medical Care Critical Care platforms
Entered into a 3-year preferred supplier agreement with Asklepios Group, one of the largest private hospital operators in Germany
Partnered with Nikkiso to distribute the PureAdjust® hemoperfusion blood pump and supplies in a total of 14 countries, a key part of CytoSorbents' standalone device and machine strategy to expand the market for its products
Hosted the 2022 CytoSorb World Users' Meeting that highlighted the broad market potential of CytoSorb as an interdisciplinary therapeutic approach for a wide range of life-threatening illnesses
Multiple scientific papers were published on the positive use of CytoSorb in the areas of antithrombotic drug removal during acute aortic dissection and in vitro whole blood removal, Ex vivo lung perfusion for lung transplantation, Normothermic regional perfusion of Donation after Circulatory Death (DCD) human liver and kidney donors for organ transplant, Severe acute pancreatitis (PACIFIC study), Treatment of hyperbilirubinemia in acute liver dysfunction patients, A reduction in sepsis-associated mortality in left-sided acute infective endocarditis, and many others.
Relocated and established our Company headquarters and state of the art manufacturing facility in our new Princeton, New Jersey mixed-use facility
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Our second quarter core non-COVID product sales on a constant currency basis were $8.2 million and stable to the average currency adjusted core product sales for the prior three quarters. Although not the growth we are seeking, we achieved this despite continued softness in the German market, as the weakened healthcare system worked to recover from the massive COVID surge in the prior quarter and grappled with a myriad of problems. These include, for example, staffing shortages, budget issues, elective procedures restrictions, and a major 11-week hospital strike in western Germany that spanned a fifth of the population, postponing more than 10,000 operations and closing hospital wards. Year-over-year results were further impacted by a lack of COVID-19 related revenue due to a lessening in disease severity globally, and a drop of 12% in the Euro, to near parity with the U.S. dollar.
"Like most international companies, including those in the medical device and blood purification industries, we are dealing with not only fallout from the COVID pandemic, but also a storm of global macroeconomic and geopolitical uncertainty. That said, although our numbers do not yet reflect it, we are seeing some early but encouraging signs of improvement in key markets:
Continued strong and positive feedback from customers in both our direct and international territories, highlighted by the success of our recent in-person CytoSorb World User's meeting, with nearly 300 of the world's leading critical care physicians and research scientists from 40 countries participating
Marked improvement in sales representative access to hospitals in Germany, with 40% more sales visits during the quarter as compared to the prior quarter, though still down from pre-pandemic levels
Increasing levels of activity, interest, and in-person attendance of healthcare professionals at medical congresses in Europe and Latin America, and specific countries such as India, Spain, and Portugal
Strong pipeline of positive data being submitted and published by the international user community on CytoSorb use in a wide variety of areas
Though early, the Nikkiso expansion has triggered broad interest by customers in our stand-alone hemoperfusion pump offering, with initial placements, pump evaluations underway, and scheduled demonstrations at a number of hospitals
Growing synergy with our sales and medical affairs teams, and internal therapy area vertical leadership in critical care, cardiac surgery, and liver and kidney applications with a prioritization on sales support and clinical data
Recent preferred supplier agreement with Asklepios Group, one of the largest private hospital networks in Germany, making CytoSorb available without restrictions to all hospitals in the network
The potential for future sales acceleration, particularly in Germany, based upon the expansion of the Fresenius Medical Care global marketing partnership announced today, as further discussed below
Dr. Chan continued, "As we work to restore sales growth, we continue to advance our other key initiatives.
U.S. STAR-T and STAR-D clinical trials – These trials remain our top clinical priority with each trial now having a critical mass of more than 20 centers active and screening for enrollment. As we expand to 30 sites for each trial, recently approved by the FDA, the majority of our operational plans, resources, and focus have shifted from study start-up activities (Phase I) to activities driving enrollment (Phase II). For our lead study STAR-T, enrollment continues and we are targeting the first Data Safety Monitoring Board (DSMB) review at 40 patients enrolled, expected to be achieved with a slight delay in the next few months. STAR-D is underway also, with the rapid activation of trial sites
U.S. Manufacturing - Buildout of our new Princeton, NJ manufacturing facility is now complete with production of commercial devices split between our older production facility and our new facility, and final certification expected before the end of this year. Product gross margins dropped from 82% to 67%, driven mainly by production inefficiencies incurred by a scheduled 4- week production hiatus as we transitioned from our old to new manufacturing facilities, and lower sales volumes. We expect gross margins to return to previous levels as we complete the relocation to the new facility, eliminate the costs of the Monmouth Junction, NJ facility later this year, and begin to capture manufacturing efficiencies driven by an expected improvement in market conditions and increased product demand
Partnerships - Today we are pleased to announce an expanded global marketing agreement with long-time partner, Fresenius Medical Care ("Fresenius"), the world's leading provider of products and services for patients with renal diseases with headquarters and a strong sales and marketing footprint in Germany. Under the terms of the agreement, CytoSorb will become a featured blood purification therapy on Fresenius Medical Care's critical care blood purification platforms for the removal of cytokines, bilirubin, and myoglobin in critically ill patients, helping to expand the dimensions of blood purification beyond hemodialysis. Fresenius will be responsible for the specific worldwide marketing and combined promotion of CytoSorb with its critical care products across Fresenius-led in-person, virtual, social media, and web-based marketing programs and events during the term of the collaboration. In addition to strengthening and expanding the global marketing of CytoSorb, we plan to work together to bring new innovative solutions to the market. To help support the increased marketing and promotional efforts of the expanded collaboration, CytoSorbents has agreed to subsidize a portion of the marketing costs through a royalty payment to Fresenius Medical Care, with the royalty rate being based on certain assumptions regarding CytoSorb sales in the intensive care unit on Fresenius Medical Care platforms, excluding the United States, and subject to further adjustment should these assumptions change. Additional information can be found in the Form 8-K filed today.
Dr. Chan concluded, "We are excited about the many opportunities that we have to drive our business forward, but are proceeding conservatively, recognizing there is a seasonality to European business in general in the third quarter, driven by a lull in business activity as much of Europe takes vacation in July and August. Because of this, we are focused on executing our game plan, while controlling costs and conserving cash. We believe the high cash burn in Q2 2022 was an anomaly with a number of non-recurrent expenditures. These include, for example, the final $4.8 million payment related to the construction, capital equipment, and other costs of our new manufacturing facility (with the exception of approximately $300K in costs for the remainder of 2022), an approximate $1 million reduction in gross margin driven mainly by inefficiencies caused by scheduled production shutdowns associated with the relocation to our new manufacturing facilities, and lower sales volumes, and a $0.6 million increase in grant and accounts receivables during the quarter. Excluding these factors, our cash burn for Q2 2022 would have been approximately $6.5 million."
'In addition, we have $5 million (based on cost of goods) in working capital tied up in CytoSorb inventory that we have strategically built over several quarters to buffer against any potential disruption in production with the transition to the new facility. With fairly good visibility that the new manufacturing facility will come on-line as expected, we plan to release and monetize a portion of this inventory, which we expect could contribute an additional $1 million to our second half 2022 cash flow. Finally, we retain financial flexibility to add debt from our $15 million term loan with Bridge Bank if desired."
Results of Operations
Comparison for the three months ended June 30, 2022 and 2021:
Revenues:
Total revenue, including product revenue and grant income, for the second quarter of 2022 was $8.5 million, down 39% from $12.0 million in the second quarter of 2021. Revenue from product sales was approximately $7.3 million in the three months ended June 30, 2022, as compared to approximately $11.4 in the three months ended June 30, 2021, a decrease of approximately $4.0 million, or 36%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $0.8 million. For the three months ended June 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.06 as compared to an average exchange rate of $1.21 for the three months ended June 30, 2021. We estimate that demand for CytoSorb to treat COVID-19 patients was de minimis in the second quarter of 2022 as compared to approximately $1.7 million in the second quarter of 2021. Overall direct sales declined by approximately $3.4 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions. COVID-19 restrictions remain in place at many hospitals throughout Germany and these restrictions continue to limit our access to hospital personnel, particularly the physicians.
Cost of Revenues:
For the three months ended June 30, 2022 and 2021, cost of revenue was approximately $3.6 million and $2.7 million, respectively. Product gross margins were approximately 67% for the three months ended June 30, 2022 as compared to approximately 82% for the three months ended June 30, 2021. The decrease in the gross margin percentage in 2022 was due primarily to inefficiencies associated with relocation of our production activities to our new manufacturing facility during the second quarter of 2022.
Operating Expenses:
For the three months ended June 30, 2022, operating expenses were approximately $13.3 million, as compared to approximately $14.2 million for the three months ended June 30, 2021, a decrease of approximately $0.9 million or 6%. Selling, general and administrative (SG&A) expenses decreased approximately 14% to $8.4 million in the quarter from $9.8 million in the prior year. This decrease was due to a decrease in royalty expenses of approximately $0.4 million due to the decrease in product sales, a decrease in non-cash restricted stock expense of approximately $1.5 million related to restricted stock units granted to the Company's executive officers and a decrease in non-cash stock compensation expense of approximately $0.8 million. This was offset by increases in salaries, commissions, and related costs of approximately $0.2 million, an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.4 million, an increase in travel and entertainment costs of approximately $0.3 million and an increase in occupancy costs of approximately $0.4 million related to the rent expense on our new manufacturing facility. Research and development expenses increased by approximately $0.5 million primarily due to costs related to our STAR-T and STAR-D trials in the United States.
Gain (Loss) on Foreign Currency Transactions:
For the three months ended June 30, 2022, the loss on foreign currency transactions was approximately $2.5 million as compared to a gain of approximately $0.2 million for the three months ended June 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar at June 30, 2022 as compared to March 31, 2022. The spot exchange rate of the Euro to the U.S. dollar was $1.05 per Euro at June 30, 2022, as compared to $1.11 per Euro at March 31, 2022.
Comparison for the six months ended June 30, 2022 and 2021:
Revenues:
Total revenues were approximately $17.2 million for the six months ended June 30, 2022, as compared to total revenues of approximately $22.6 million for the six months ended June 30, 2021, a decrease of approximately $5.4 million, or 24%. Revenue from product sales was approximately $15.3 million in the six months ended June 30, 2022, as compared to approximately $21.5 million in the six months ended June 30, 2021, a decrease of approximately $6.2 million or 29%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $1.4 million. For the six months ended June 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.09 as compared to an average exchange rate of $1.21 for the six months ended June 30, 2021. Though difficult to quantify, we estimate that approximately $0.3 million of total product sales in the six months ended June 30, 2022 was due to the demand for CytoSorb to treat COVID-19 patients as compared to $3.5 million in the six months ended June 30, 2021. Overall direct sales declined by of approximately $5.4 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions. COVID-19 restrictions remain in place at many hospitals throughout Germany and these restrictions continue to limit our access to hospital personnel, particularly the physicians.
Cost of Revenues:
For the six months ended June 30, 2022 and 2021, cost of revenue was approximately $5.8 million and $5.5 million, respectively, an increase of approximately $0.3 million. Product gross margins were approximately 74% for the six months ended June 30, 2022 and approximately 79% for the six months ended June 30, 2021. The reduction in product gross margin is due primarily to inefficiencies associated with the relocation of our production activities to our new manufacturing facility during the second quarter of 2022.
Operating Expenses:
For the six months ended June 30, 2022, operating expenses were approximately $27.5 million as compared to approximately $24.9 million for the six months ended June 30, 2021, an increase of approximately $2.6 million, or 10%, for the six months ended June 30, 2022. Research and development expenses were approximately $8.4 million as compared to approximately $6.0 million for the six months ended June 30, 2021, an increase of approximately $2.4 million or 40%. This increase was due to an increase in costs associated with our STAR-T and STAR-D trials in the United States. Selling, general and administrative expenses were approximately $17.6 million for the six months ended June 30, 2022, as compared to $17.5 million for the six months ended June 30, 2021, an increase of $0.1 million. This increase is related to an increase in salaries, commissions and related costs of approximately $1.2 million, an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.7 million, an increase in travel and entertainment costs of approximately $0.5 million and an increase in occupancy costs of approximately $0.7 million related to the rent expense on our new manufacturing facility. These increases were offset by a decrease in royalty expenses of approximately $0.5 million, a decrease in non-cash restricted stock expense of approximately $1.7 million related to restricted stock units granted to the Company's executive officers, a decrease in non-cash stock compensation expense of approximately $0.7 million.
Gain (Loss) on Foreign Currency Transactions:
For the six months ended June 30, 2022, the loss on foreign currency transactions was approximately $3.7 million as compared to a loss of approximately $1.1 million for the six months ended June 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2022 as compared to December 31, 2021. The spot exchange rate of the Euro to the U.S. dollar was $1.05 per Euro as of June 30, 2022, as compared to $1.14 per Euro at December 31, 2021.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of June 30, 2022, we had current assets of approximately $41.6 million including unrestricted cash on hand of approximately $30.2 million and current liabilities of approximately $10.6 million. As of June 30, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which is still available. In addition, we have $15 million of debt availability, providing financial flexibility, if needed. In April 2022, we received approximately $0.7 million in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.
We are also managing our resources proactively, continuing to invest in key areas such as our U.S. pivotal STAR-T and STAR-D trials. In April 2022, we began instituting tighter cost controls which are expected to reduce our planned cash burn by an additional $2 million per quarter. We are currently actively engaged in making further reductions to our operating costs to reduce our future cash burn.
We believe that we have sufficient cash to fund the Company's operations beyond twelve months from the issuance of these financial statements.
2022 Outlook Guidance
The macro environment in which we operate remains difficult to predict given the complex drivers of our business, the global nature of our operations, and external factors such as the COVID-19 pandemic, the Russia-Ukraine war, inflation, foreign currency exchange rate volatility, and other factors that are not under our direct control. Because of this, we expect that our business, and in particular product sales, may continue to see challenges for the remainder of 2022. However, we expect a gradual recovery of normalized hospital activity and sales access in Germany and other key countries in the coming quarters. With improved access and other growth initiatives, we expect a resumption of growth in our core non-COVID-19 product sales.
For additional information, please see the Company's Form 10-Q for the period ended June 30, 2022 filed on August 2, 2022 on http://www.sec.gov.
Conference Call
The Company will conduct its second quarter 2022 results call today at 4:30 p.m. Eastern time.
Conference Call Details:
Date: Tuesday, August 2, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
Live Presentation Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
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=1561029&tp_key=ddc6a4af76
An archived recording of the conference call will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 179,000 cumulative CytoSorb devices have been utilized as of June 30, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind 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, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $39.5 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine or other macroeconomic factors, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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U.S. Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
avogel@cytosorbents.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
marcus.schult@die-kommponisten.com
SOURCE CytoSorbents Corporation
https://www.prnewswire.com/news-releases/cytosorbents-reports-second-quarter-2022-financial-and-operational-results-301598385.html
Comparison of the CytoSorb ® 300 mL and Jafron HA380 hemoadsorption devices: an in vitro study
Axel Nierhaus et al. Minim Invasive Ther Allied Technol. 2022.
Hide details
Minim Invasive Ther Allied Technol
. 2022 Aug 1;1-8.
doi: 10.1080/13645706.2022.2104617. Online ahead of print.
Authors
Axel Nierhaus 1 2 , Jesus Morales 3 , Daniel Wendt 3 4 , Jörg Scheier 3 , Dominik Gutzler 3 , Dominik Jarczak 1 2 , Frank Born 5 , Christian Hagl 5 , Efthymios Deliargyris 3 , Yatin Mehta 6
Affiliations
1 Clinic for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg, Hamburg, Germany.
2 Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
3 CytoSorbents, Princeton, NJ, USA.
4 Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, Essen, Germany.
5 Department of Cardiac Surgery, University Hospital, LMU Munich, Munich, Germany.
6 Medanta Institute of Critical Care and Anesthesiology, Gurgaon, India.
PMID: 35913784
DOI: 10.1080/13645706.2022.2104617
Cite
Abstract
Introduction: We performed an analysis of two blood purification systems to determine their performance for removing interleukins (ILs)-6 and 10, tumor necrosis factor (TNF)-a and monocyte chemoattractant protein (MCP)-1 from blood.
Material and methods: An in vitro hemoperfusion blood recirculation circuit was used to compare the CytoSorb® 300 mL (CytoSorbents Inc., Princeton, NJ) and Jafron HA 380 (Jafron Biomedical Co., Ltd., Zhuhai City, China) devices. The removal of purified recombinant human IL-6, IL-10, TNFa and MCP-1 by the adsorbers was compared at various timepoints. Three runs were completed and removal was evaluated as the mean area under the curve (AUC).
Results: Both devices showed effective removal of the tested cytokines. IL-6, IL-10, TNFa and MCP-1 were removed faster and to a higher extent by the CytoSorb® 300 mL device. At maximal time of 12 h, overall removal according to AUC of remaining concentrations was significantly lower with CytoSorb® 300 mL compared with HA 380 (IL-6: 1075.5 ± 665.9 vs. 4345.1 ± 1499.3 (p = 0.01), IL-10: 5065.7 ± 882.5 vs. 11,939.7 ± 4523.1 (p = 0.03), TNF-a: 6519.9 ± 997.6 vs. 10,303.7 ± 2347.0 (p = 0.03) and MCP-1: 278.9 ± 40.7 vs. 607.3 ± 84.4 (p = 0.001)).
Conclusions: Both the CytoSorb® and the Jafron HA 380 devices are capable of removing cytokines from blood in a benchtop model. The CytoSorb® 300 device was significantly more efficient achieving the bulk of the removal in the first 120 min.
Anyone know what this USPTO Patent hearing #2022-001867 is all about scheduled for this Tuesday @ 1pm in Virginia?
https://www.uspto.gov › filesPDF
AUGUST 2022 PTAB Public Hearing Schedule - USPTO
24 hours ago — CYTOSORBENTS CORPORATION. Tuesday, August 2, 2022. 1:00 PM (EDT). ALEXANDRIA, VA. B. 2022-002557. 15763920. RB HEALTH (US) LLC. Tuesday, August 2, 2022.
Literature Database
Reduction of primary graft dysfunction using cytokine adsorption during organ preservation and after lung transplantation
Ghaidan H, Stenli M, Niroomand A, Mittendorfer M, Hirdman G, Gvazava N, Edström D, Silva IAN, Broberg E, Hallgren O, Olm F, Wagner DE, Pierre L, Hyllén S, Lindstedt S. Nature Communications 2022; 13:4173
07/27/2022
New!Peer Reviewed Published DataSafetyTransplantImprov. resp functionAnimal modelsARDSExperimental setupInflammatory parameters
Link to source
Summary
Despite improvements, lung transplantation for end-stage disease remains hampered by both a scarcity of donor organs and by mortality following primary graft dysfunction (PGD). Since acute respiratory distress syndrome (ARDS) limits donor lung utilization, this study investigated the use of CytoSorb cytokine adsorption as a means of treating ARDS donor lungs. Ex-vivo lung perfusion (EVLP) was used to assess the donor lungs. Mild to moderate ARDS was induced via lipopolysaccharide (LPS) in 16 donor pigs. The non-treated group received EVLP and underwent transplantation without cytokine adsorption. The treated groups were subdivided between a ‘two step’ group (lungs were treated with CytoSorb both during EVLP (4 hours) and for 12 hours post transplantation) and a ‘one step’ group (use of CytoSorb only for 12 hrs postop). The primary endpoint of lung function was the PaO2/FiO2 ratio. Results showed that treatment with CytoSorb significantly decreased cytokine levels during EVLP and decreased levels of immune cells post-transplantation. Histology demonstrated fewer signs of lung injury across both treatment periods and the incidence of PGD was significantly reduced among treated animals. The effects of CytoSorb seemed to increase when used at two times points. In summary, CytoSorb cytokine adsorption in the context of ARDS injured lungs (i) reduced inflammation and restored pulmonary function during EVLP, (ii) restored pulmonary function and decreased inflammation following transplantation, and (iii) reduced the incidence of PGD in transplanted recipients. The authors suggest this treatment will increase the availability of donor lungs and increase the tolerability of donor lungs in the recipient.
YouTube video out, presentation from Cytosorbents conference on pig heart transplants etc.
Url -
Case of the Week
Literature Database
Use of CytoSorb hemoadsorption column during prolonged cardiopulmonary bypass in complex cardiac surgery patient
Marianne Alarie*, Maggie Savelberg, Danika Vautour and Igo B. Ribeiro | Kingston Health Sciences Centre, Kingston, ON, Canada | J Cardiothorac Surg 2022 Jul 7;17(1):172
07/27/2022
New!Peer Reviewed Published DataReduction in catecholaminesSafetyCardiac surgeryCase of the weekCase reportCPBIntra-Op
Download documentDownload documentLink to source
Summary
CoW 30/2022 – This case reports on a 61-year-old male, who was assessed by cardiac surgery in consideration for mitral valve surgery following presentation for congestive heart failure.
Summary
In this report a 61-year-old male with congestive heart failure was assessed for cardiac surgery, and was found to require mitral valve replacement, aortic valve replacement, tricuspid valve repair, single coronary artery bypass grafting and a left atrial appendage clip. Given the complexity of the surgery, the anticipated prolonged length of cardiopulmonary bypass, the associated risk of significant vasoplegia and his preoperative kidney dysfunction, the decision was made to integrate the CytoSorb cartridge into the cardiopulmonary bypass (CPB) circuit. One CytoSorb hemoadsorber was used intraoperatively throughout the CPB time (154 min). Despite an initial rise in vasopressor requirements, the mean arterial pressure (MAP) gradually improved during the time on by-pass whilst vasopressors could be weaned off completely. However, ten minutes post-bypass (i.e. after discontinuation of CytoSorb), the patient once again required multiple vasopressors to support his MAP. Despite the presence of postoperative thrombocytopenia, postoperative platelet counts did not significantly differ from baseline. Treatment was safe and feasible while integration into the cardiopulmonary bypass circuit was uncomplicated with no device-related complications. In this complex cardiac surgery patient, the authors state that the application of CytoSorb during cardiopulmonary bypass contributed to a decreased need for vasoactive support during and after surgery as well as improved postoperative outcomes, rendering it a promising therapeutic option in critically ill patients at risk of significant postoperative vasoplegia and multiorgan injury following prolonged and complex cardiac surgery.
Case presentation
Transthoracic echocardiography showed significant mitral valve calcification resulting in severe mitral regurgitation and moderate mitral stenosis. The right and left ventricles both had mild dysfunction with an ejection fraction of 46%. Further evaluation with transesophageal echocardiography revealed moderate aortic cusp calcification with moderate stenosis. Moderate tricuspid regurgitation was also noted. Coronary angiography revealed the presence of significant coronary artery disease with second diagonal ostial stenosis
The patient’s medical history included end-stage renal disease requiring intermittent hemodialysis, autoimmune cytopenia (severe thrombocytopenia, neutropenia) with mild responsiveness to preoperative steroids, New York Heart Association class III heart failure, hypertension, chronic obstructive pulmonary disease, severe untreated sleep apnea, previous Graves` disease diagnosis and atrial fibrillation
The patients’ preoperative blood work included a platelet count of 74?×?109/L, hemoglobin 91 g/L and hematocrit 29%. Preoperative creatinine was 598 µmol/L and glomerular filtration rate (GFR) was 8 mL/min/1.73 m2
The procedure included mitral valve replacement, aortic valve replacement, tricuspid valve repair, single coronary artery bypass grafting and left atrial appendage clip. Total cardiopulmonary bypass (CPB) time was 154 min, with a cross-clamp time of 115 min
Following induction of anesthesia and prior to commencement of the CPB, the patient required norepinephrine at 2 µg/min for hemodynamic support
A total of 3 units of packed red blood cells (pRBC), 2 units of platelets and 1 unit of prothrombin complex concentrate were administered to treat his perioperative anemia and coagulopathy
Given the complexity of the surgery (triple valve surgery), the anticipated prolonged length of cardiopulmonary bypass, the associated risk of significant vasoplegia and the preoperative kidney dysfunction, the decision was made to integrate the CytoSorb cartridge into the cardiopulmonary bypass circuit in this critically ill patient
Treatment
One CytoSorb hemoadsorber was used intraoperatively throughout the CPB time (154 min)
The CytoSorb device was inserted between the recirculation line (high-pressure line) and the venous reservoir of the CPB circuit. The cartridge was placed in a parallel fashion with the hemoconcentrator. The cartridge was primed and flushed with one liter of Ringer’s Lactate
Estimated blood flow rates through the CytoSorb: 200-230 mL/min
Anticoagulation: heparin with target activated clotting times (ACT) greater than 400 s, monitored every 20 to 30 min
Measurements
Hemodynamics and requirements for vasoactive substances
Total chest tube drainage volume
Ultrafiltration rate
Thrombocytes
Safety
Results
Following initiation of CPB and CytoSorb, norepinephrine infusion was increased to 5 µg/min for the first half hour of the bypass run under which the mean arterial pressure (MAP) could be sustained at around 45–50 mmHg. At the 40 min mark, MAP increased to a mean of 65–70 mmHg and the norepinephrine dose was reduced to 2 µg/min. After one hour on bypass, MAP increased to 70–75 mmHg and norepinephrine was discontinued. MAP levels above 60 mmHg were sustained for the remainder of the bypass run and there was no additional need for vasoactive support. Ten min post-bypass (i.e. after discontinuation of CytoSorb), the patient required dobutamine 5 µg/kg/min, norepinephrine 4 µg/min, epinephrine 5 µg/min and vasopressin 0.04 units/min for support. The patient was transferred to the cardiac intensive care unit on 5 µg/kg/min of dobutamine, 6 µg/min of norepinephrine, 5 µg/min of epinephrine and 0.04 units/min of vasopressin. Dobutamine was discontinued within the first postoperative hour. Vasopressin was stopped 24 h postoperatively. Norepinephrine was discontinued by the end of the 2nd postoperative day while epinephrine was eventually discontinued 48 h postoperatively
Total chest tube drainage was measured to be 1080 mL
Zero balance ultrafiltration was performed during bypass, with a total of 2.2 L of dialysate solution administered and 5.2 L of fluid removed via the hemoconcentrator
Postoperative platelet counts did not significantly differ from baseline
No adverse or any device-related side effects were documented during or after CytoSorb treatment
Patient Follow-up
Early postoperative blood work showed somewhat improved kidney function, with a creatinine of 394 umol/L and a GFR of 13 mL/min/1.73 m2
Lactate levels peaked at 3.4 mmol/L on the 6th postoperative hour and quickly normalized over the next 24 hours
Following the first postoperative day, the patient received an additional 3 units of pRBC, 2 units of fresh frozen plasma and 1 unit of platelets
Surgical drains were removed on the second postoperative day
The patient was extubated 48 h post-surgery
Hemodialysis treatments were resumed on the third postoperative day
The patient was transferred to the normal ward on the 6th postoperative day and discharged on the 11th postoperative day
Conclusion
In this complex cardiac surgery patient, application of CytoSorb during cardiopulmonary bypass contributed to a decreased need for vasoactive support during and after surgery as well as improved postoperative outcomes, rendering it a promising therapeutic option in critically ill patients at risk of significant postoperative vasoplegia and multiorgan injury following prolonged and complex cardiac surgery
The authors do not believe that CytoSorb therapy significantly impacted on the platelet concentrations or perioperative transfusion requirements
Treatment was safe and feasible while integration into the cardiopulmonary bypass circuit was uncomplicated with no device-related complications observed.
NEWS -- CytoSorbents to Report Second Quarter 2022 Operating and Financial Results
PRINCETON, N.J., July 25, 2022 /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, will report second quarter 2022 operating and financial results after the market close on August 2nd, 2022. CytoSorbents' management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.
Conference call details:
Date: Tuesday, August 2, 2022
Time: 4:30 p.m. Eastern
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
The live audio webcast and presentation can be accessed via the following link: https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations portion of the company's website at https://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind 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, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $39.5 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 https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
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Case of the Week
Literature Database
Use of CytoSorb in a post kidney transplant pediatric patient with acute respiratory failure and sepsis
Dr. Rajiv Sinha | Paediatric Nephrology, Apollo Multispeciality Hospital, Kolkata, India
07/20/2022
New!PediatricsReduction in catecholaminesSafetySeptic ShockImprov. resp functionCase of the weekCase reportCritical CareIHD / SLEDInflammatory parameters
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Summary
CoW 29/2022 – This case reports on a 13-year-old girl from Bangladesh, who was admitted to the hospital with incipient renal failure and hypertension.
Case presentation
At the age of 9 months, she had been diagnosed with steroid resistant nephrotic syndrome secondary to WT1 mutation. She slowly progressed to end-stage renal disease and underwent bilateral nephrectomy and initiation of chronic peritoneal dialysis. Kidney transplantation was performed within 6 months (February, 2014), where the donor was the child’s mother. The patient was then on regular follow-ups in India until the current renal deterioration happened
On admission, the patient was found to have a creatinine of 2.5 mg/dl along with severe hypertension for which the patient was put on multiple anti-hypertensive drug therapy. A transplant renal biopsy was performed suggesting thrombotic microangiopathy. In view of her deteriorating renal function, the patient was prepared for renal replacement therapy (Perma-catheter insertion for hemodialysis)
Following admission, the patient’s condition deteriorated including epistaxis, dyspnoea, tachycardia, desaturation on room air and altered sensorium with increasing respiratory distress
Laboratory investigations revealed a leucocyte count of 13,700/µl, 91% neutrophils, platelets 0.85 lacs/cumm, C-reactive protein (CRP) 29.7mg/dl, INR of 4, aPTT of 120 secs, urea 142 mg/dl, and creatinine 4.1mg/dl
A subsequent chest X-ray showed patchy consolidations in the right perihilar region
She went on to develop hemodynamic instability with a drop in mean arterial pressure to 60 mmHg requiring initiation of vasopressor therapy (norepinephrine 0.8 µg/kg/min, epinephrine 0.5 µg/kg/min)
Additionally, the patient was intubated and put on mechanical ventilation with high ventilator settings including a positive end-expiratory pressure (PEEP) of 13 cmH2O, a peak inspiratory pressure (PIP) of 42 cmH2O, an FiO2 of 100% and a tidal volume of 5 ml/kg
Intravenous antibiotics were administered
Hemodialysis was initiated but had to be discontinued due to hypotension and the renal replacement therapy (RRT) modality was switched to Sustained Low Efficiency Dialysis (SLED)
As the patient was unresponsive to standard therapy and due to the ongoing clinical deterioration along with increased inflammatory markers (D-Dimer 2524.6 ng/ml, IL-6 5000 pg/ml), the decision was made to additionally integrate a CytoSorb hemoadsorber in order to control the hyperinflammatory response and to stabilize the patient hemodynamically
Treatment
One CytoSorb therapy session was performed for 8 hours on day 1
CytoSorb was used in conjunction with SLED therapy
Measurements
Hemodynamics and vasopressor requirements
Inflammatory markers
Ventilation invasiveness and oxygenation
Results
CytoSorb treatment resulted in a considerable improvement in the patient’s hemodynamic situation. 24 hours after initiation of therapy, norepinephrine had already decreased to 0.5 µg/kg/min and epinephrine to 0.1 µg/kg/min and continued to decrease also after cessation of CytoSorb therapy
Treatment with CytoSorb was further associated with a marked reduction in IL-6 (decrease from >5000 pg/ml to 44 pg/ml over the following 24 hours), indicating a clear control of the hyperinflammatory situation
Moreover, ventilation invasiveness decreased, and oxygenation improved
Patient Follow-up
RRT was continued for several consecutive days along with other supportive management
As the patient improved clinically, she was extubated on day 4 and kept on high flow oxygen therapy via nasal cannula
Antibiotic therapy was initiated for 14 days as the blood cultures were positive for Staphylococcus epidermidis(Coagulase-Negative Staphylococci)
The patient was finally discharged in a clinically stable condition with a follow-up plan for intermittent hemodialysis
Conclusion
In this case of a post kidney transplant pediatric patient with acute respiratory failure and sepsis, the use of CytoSorb hemoadsorption in combination with renal replacement therapy and standard therapeutic measures resulted in rapid hemodynamic stabilization, control of the hyperinflammatory response as well as improvement in ventilation invasiveness and oxygenation
Hemoadsorption therapy may therefore be a potentially important advance in the control of such conditions, if instituted early and judiciously. The presented case successfully adds to the growing experience from eastern India as the first case of pediatric hemoadsorption therapy
Use of CytoSorb in combination with SLED was safe and easy.
Hemoadsorption for severe MIS-C in critically ill children, should we consider it as a therapeutic opportunity?
Gabriella Bottari et al. Int J Artif Organs. 2022.
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Int J Artif Organs
. 2022 Jul 13;3913988221111179.
doi: 10.1177/03913988221111179. Online ahead of print.
Authors
Gabriella Bottari 1 , Flavia Severini 2 , Anna Hermine Markowich 2 , Giulia Lorenzetti 2 , Juan Carlos Ruiz Rodriguez 3 4 , Ricard Ferrer 3 4 , Paola Francalanci 5 , Antonio Ammirati 6 , Paolo Palma 7 , Corrado Cecchetti 1
Affiliations
1 Pediatric Intensive Care Unit, Pediatric Emergency Department, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
2 Department of Pediatrics, University of Rome Tor Vergata, Residency School of Pediatrics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
3 Intensive Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
4 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d'Hebron Research, Institute (VHIR), Barcelona, Spain.
5 Unit of Pathology, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
6 Pediatric Emergency Unit, Pediatric Emergency Department, Bambino Gesù Children's Hospital, IRCSS, Rome, Italy.
7 Clinical Immunology and Vaccinology Unit, Pediatric Academic Department (DPUO), Bambino Gesù Children's Hospital, IRCSS, Rome, Italy.
PMID: 35822878
DOI: 10.1177/03913988221111179
Cite
Abstract
Multisystem inflammatory syndrome (MIS-C) is a new severe clinical condition that has emerged during the COVID-19 pandemic. MIS-C affects children and the young usually after a mild or asymptomatic COVID-19 infection. MIS-C has a high tropism for the cardiovascular system with need for inotropes and vasopressor support in 62% of cases. As of today a mortality from 1.5% to 1.9% related to MIS-C is reported. Hemoadsorption via the inflammatory mediator adsorber CytoSorb (CytoSorbents Europe, Berlin Germany) has been used as adjunctive therapy with the aim to restore the host response in septic shock and other hyper-inflammatory syndromes. We present the clinical experience of an adolescent boy with a refractory shock secondary to left ventricular dysfunction (LVD) in the context of MIS-C, treated with hemoadsorption, and continuous kidney replacement therapy (CKRT) in combination with immunomodulatory therapies. The therapeutic strategy resulted in hemodynamic and clinical stabilization as well as control of the hyperinflammatory response. Treatment appeared to be safe and feasible. Our findings are in line with previously published clinical cases on Cytosorb use in MIS-C showing the beneficial role of the hemoperfusion with Cytosorb in severe MIS-C to manage the cytokine storm. We provide an analysis and comparison of recent evidence on the use of hemoadsorption as an adjuvant therapy in critically ill children with severe forms of MIS-C, suggesting this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygentation (ECMO) and other mechanical cardiocirculatory supports.
Keywords: Coronavirus; cytokines; left venticular failure (LVEF); multisystem inflammatory syndrome in children (MIS-C); myocarditis; pediatric critical care; shock.
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