Paulness
3 weeks ago
NEWS -- CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan
Brings a powerful blood purification technology used to treat critically ill and cardiac surgery patients in nearly a quarter million treatments across 75 countries to date to one of the most progressive healthcare systems in the world
PRINCETON, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the regulatory approval of CytoSorb® in Taiwan by the Taiwan Food and Drug Administration (TFDA). The approved indications include the extracorporeal removal of cytokines (e.g. cytokine storm, sepsis), bilirubin (e.g. liver disease), and myoglobin (e.g. trauma) from a patient’s circulating blood. The removal of the antithrombotic drugs Brilinta® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Janssen/Bayer) during cardiothoracic surgery is also approved, with the goal of reducing perioperative bleeding. CytoSorb will be distributed throughout Taiwan by Hemoscien Corporation.
Ms. Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents stated, “We are thrilled to announce this milestone which underscores the value and efficacy of our CytoSorb therapy and was achieved after navigating a long and complex approval process. We look forward to collaborating with Hemoscien and leveraging their long-standing customer relationships in Taiwan to bring this innovative therapy to patients in need.”
Mr. Tom Juan, Managing Director of Hemoscien Corporation emphasized, “There is an ongoing critical need for more effective therapies to combat infections and to prevent or treat organ failure. I firmly believe that advanced blood purification devices such as CytoSorb® can complement the limitations of traditional pharmaceuticals by restoring peripheral blood homeostasis and balance. Given the widespread and successful application of CytoSorb therapy in numerous countries to treat life-threatening critical illnesses, we are confident in our ability to take what has been learned and to market and support CytoSorb in Taiwan's ICU sectors through our deep critical care network to help save the lives of severely ill patients.”
In addition to Taiwan, 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 such as sepsis and septic shock, trauma, acute respiratory distress syndrome, burn injury, pancreatitis, and others that can lead to massive inflammation, organ failure and patient death. CytoSorb is also used as an extracorporeal liver support therapy in acute liver disease (e.g. acute on chronic liver failure, alcoholic hepatitis) and removes both liver toxins, such as bilirubin and bile acids, as well as cytokines. It is also used to treat rhabdomyolysis (e.g. trauma) and the removal of myoglobin. In these diseases, the risk of death can be extremely high, and there are few, if any, effective or practical treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively around the world.
Taiwan, with approximately 24 million inhabitants, offers universal coverage to its citizens through its National Health Insurance System and serves them through a network of nearly 400 medical centers and regional hospitals. With rising medical standards, use of advanced technology to increase administrative and provider efficiency, and access to high quality healthcare, Taiwan boasts one of the most progressive healthcare systems globally. Like many other parts of the world, critical illness including sepsis is a major problem in Taiwan. For example, there are 150,000 estimated new cases of sepsis reported each year in Taiwan with mortality rates as high as 30%, driven by diseases such as pneumonia, which is the third leading cause of death in Taiwan.
About Hemoscien Corporation
Hemoscien Corporation, a specialized hemo-epuration service provider, was established in 2008 as a spinoff from Smile Group Corp., originally founded in 1980. Since 1998, Hemoscien has maintained a strong partnership with Infomed S.A., a respected ICU hemo-therapy platform developer, achieving over 50% market share. The company is dedicated to its mission of addressing unmet medical needs in ICU care, as well as advancing regenerative medicine and other immune therapies.
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. CytoSorb, the Company’s flagship product, was originally launched in the European Union under CE mark as the first cytokine adsorber. In addition to the description in the text above, CytoSorb 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.
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 $50 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™, 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 X.
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, statements about potential exposures resulting from our cash positions, 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 14, 2024, 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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U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
mailto://kbloch@cytosorbents.com
Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
mailto://ir@cytosorbents.com
Good Sport
6 months ago
Here comes the Class Action against Cytosorbents !!!
https://www.accesswire.com/viewarticle.aspx?id=822116&lang=en
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Cytosorbents Corporation - CTSO
NEWS PROVIDED BY
ACCESSWIRE
Jan 04, 2024, 3:00 PM ET
"NEW YORK, NY / ACCESSWIRE / January 4, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Cytosorbents Corporation ("Cytosorbents" or the "Company") (NASDAQ:CTSO). Such investors are advised to contact Danielle Peyton at newaction[ @, ext. 7980.
The investigation concerns whether Cytosorbents and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
On December 28, 2023, Cytosorbents issued a press release announcing that its pivotal trial investigating the ability of its device candidate, DrugSorb®-ATR, to reduce perioperative bleeding in patients on ticagrelor (Brilinta®, Brilique® - AstraZeneca) undergoing cardiothoracic surgery before completing the recommended washout period, "did not meet the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries."
On this news, Cytosorbents' stock price fell $0.545 per share, or 33.44%, to close at $1.085 per share on December 28, 2023."
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
SOURCE: Pomerantz LLP
View the original press release on accesswire.com
Good Sport
6 months ago
Hemoadsorption Therapy for Critically Ill Patients with Acute Liver Dysfunction: A Meta-Analysis and Systematic Review
by Caner Turan
1,2ORCID,Csenge Erzsébet Szigetváry 1,2ORCID,Tamás Kói 2,3,Marie Anne Engh 2ORCID,Isil Atakan 2,László Zubek 2,Tamás Terebessy 2,4,Péter Hegyi 2,5,6 andZsolt Molnár 1,2,7,*ORCID
1. Department of Anesthesiology and Intensive Therapy, Semmelweis University, 1085 Budapest, Hungary
2.Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
3.Department of Stochastics, Institute of Mathematics, Budapest University of Technology and Economics, 1111 Budapest, Hungary
4.Department of Orthopaedics, Semmelweis University, 1085 Budapest, Hungary
5.Institute of Pancreatic Diseases, Semmelweis University, 1085 Budapest, Hungary
6.Institute for Translational Medicine, Medical School, University of Pécs, 7623 Pécs, Hungary
7.Department of Anesthesiology and Intensive Therapy, Poznan University of Medical Sciences, 60-806 Poznan, Poland
*
Author to whom correspondence should be addressed.
Biomedicines 2024, 12(1), 67; https://doi.org/10.3390/biomedicines12010067
Submission received: 16 November 2023 / Revised: 15 December 2023 / Accepted: 24 December 2023 / Published: 27 December 2023
URL:
https://www.mdpi.com/2227-9059/12/1/67
Good Sport
11 months ago
CLINICAL TRIAL article
Front. Pediatr.
Sec. Pediatric Critical Care
Volume 11 - 2023 | doi: 10.3389/fped.2023.1259384
Impact of CytoSorb and CKRT on hemodynamics in pediatric patients with septic shock: the PedCyto study
study
Gabriella Bottari1, 2* Isabella Guzzo1, 3 Andrea Cappoli1, 3 Raffaella Labbadia1, 3 Salvatore Perdichizzi1, 2 Carmela Serpe1 Jacques Creteur4, 5 Corrado Cecchetti1, 2 Fabio Silvio Taccone4, 5
1Bambino Gesù Children's Hospital (IRCCS), Italy
2Pediatric Intensive Care Unit Children's Hospital Bambino Gesù, Italy
3Unit of Nephrology and Dialysis, Department of Specialized Pediatrics and Kidney Liver Transplantation, Bambino Gesù Children's Hospital (IRCCS), Italy
4Hôpital Erasme, Université libre de Bruxelles, Belgium
5Service de Soins Intensifs, Hôpital Erasme, Université Libre de Bruxelles, Belgium
Background: There is a lack of data to support the use of hemoadsorption in pediatric septic shock.The aim of our study was to assess the effectiveness and safety of Cytosorb therapy in this setting.Phase II interventional single arm pilot study in which 17 consecutive children admitted with septic shock who required continuous kidney replacement therapy (CKRT) and weighed ≥ 10 kg were included. A CytoSorb (CytoSorbents Inc, New Jersey, USA) hemoadsorption cartridge was added to the CKRT every 24 hours for a maximum of 96 hours. A control group of 13 children with septic shock treated with CKRT but not hemoadsorption at Children's Hospital Bambino Gesù and enrolled in the EuroAKId register was selected as an historical cohort. The primary outcome of the study was a reduction in vasopressor or inotrope dose of > 50% from baseline by the end of Cytosorb therapy. Secondary outcomes included hemodynamic and biological changes, changes in severity scores, and 28-day mortality.Results: There were significant decreases in the Vasoactive Inotropic Score (VIS) and the Pediatric Logistic Organ Dysfunction 2 (PELOD-2) score at 72 and 96 hours from the start of the Cytosorb therapy compared to baseline; the reductions were larger in the hemoadsorption group than in the control group (historical cohort). 28-day mortality was lower, although not significantly, in the hemoadsorption group when compared to the control group (5/17 [29%] vs. 8/13 [61%] OR 0.26 [95% CI 0.05-1.2]; p= 0.08).
Conclusions: CytoSorb therapy may have some benefits in pediatric patients with septic shock. Future larger randomized trials are needed in this setting.
Received: 15 Jul 2023; Accepted: 21 Aug 2023.
Copyright: © 2023 Bottari, Guzzo, Cappoli, Labbadia, Perdichizzi, Serpe, Creteur, Cecchetti and Taccone. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Gabriella Bottari, Bambino Gesù Children's Hospital (IRCCS), Rome, Italy
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
https://www.frontiersin.org/articles/10.3389/fped.2023.1259384/abstract
Paulness
11 months ago
NEWS -- CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial
Readout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage for potential regulatory submission to FDA and Health Canada as the first reversal agent for the blood thinner, Brilinta®
PRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up. The STAR-T trial is evaluating the ability of DrugSorb®-ATR to reduce perioperative bleeding due to the widely-used blood thinner, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We are very pleased to complete all patient related procedures in the STAR-T trial without a single study subject lost to follow-up. This is another critical step of the process delivered on time and with 100% success. We are focused on ensuring complete and high-quality study data collection, ultimately leading to database lock and triggering the statistical analyses that will provide the readouts of the trial. We continue to expect topline results by the end of the year."
Brilinta® is one of the leading "blood thinners" used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. However, in the up to 10% of patients that are not eligible for a cardiac stent and now require coronary artery bypass graft (CABG) surgery, Brilinta confers a risk of major fatal or life-threatening CABG-related bleeding as high as 50-65%, particularly if the surgery is performed within the first five days of receiving the drug. Waiting in the hospital to wash out the drug is the only acceptable alternative, but comes at high cost and potential clinical risk. The goal of using DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug from blood during the surgery when installed in the heart-lung machine. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study was conducted by many leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce "cytokine storm" and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. 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, statements about potential exposures resulting from our cash positions, 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 9, 2023, 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
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-completes-us-and-canadian-star-t-pivotal-trial-301899656.html
SOURCE CytoSorbents Corporation
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