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.
Specifically, the Hospital Technologies Committee of the Israeli MoH has approved national CytoSorb reimbursement, also known as “addition to the Healthcare Basket,” for the following indications:
- Intraoperative treatment for urgent or emergency cardiac surgery in patients treated with ticagrelor or rivaroxaban
- Intraoperative treatment during cardiac surgery in patients with acute infective endocarditis
- Intraoperative treatment during surgery for correction of aortic dissection
With its decision, the Committee recognizes the importance and value of CytoSorb to remove a variety of antithrombotic drugs and inflammatory mediators intraoperatively during cardiac surgery. Once the policy revision is completed, public hospitals are expected to receive reimbursement for CytoSorb for these applications.
Christian Steiner, M.D., Executive Vice President, Sales and Marketing of CytoSorbents, stated, “Israel has one of the highest quality and advanced healthcare systems in the world, strengthened by its leadership in adopting innovative medical technologies. We are pleased that the Ministry of Health recognizes the benefits of intraoperative CytoSorb use in cardiac surgery and has approved national reimbursement.”
Israel has a population of approximately 9 million people, all of whom are covered by universal health insurance. Annually, the country spends about 7.5% of its gross domestic product (GDP) on healthcare. Israel spends an estimated $2.4 billion annually on medical devices, with imports accounting for approximately 65% of the medical device market. According to the Israel Heart Society, heart disease is the second leading cause of death in the country. More than 4,000 heart surgeries are performed in Israel each year.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in critical care and cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and marketed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that occurs in common critical illnesses and 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 worldwide. CytoSorb was originally launched in the European Union under the CE Mark as the first extracorporeal 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 during cardiothoracic surgery. CytoSorb has also received FDA emergency approval 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 FDA Breakthrough Device Designation to remove ticagrelor and FDA Breakthrough Device Designation to remove 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 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 perioperative bleeding risk in ticagrelor patients 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 who are 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 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 www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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.
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SOURCE CytoSorbents Corporation