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.

Dr. Christian Steiner, Executive Vice President, Sales and Marketing of CytoSorbents, stated, "We greatly appreciate the Turkish Ministry of Health's recognition of the important role CytoSorb can play in the management of complex patients who are critically ill or are undergoing cardiothoracic surgery.  Each year in Turkey, there are an estimated 140,000 patients treated in the ICU for severe sepsis or septic shock related to infection, with a high risk of death. There are also more than an estimated 75,000 patients who undergo cardiothoracic surgery annually, many of whom are medical tourists treated in private hospitals.  In addition, there are numerous other critically ill patients suffering from other life-threatening conditions such as acute lung or liver failure, trauma, and others where CytoSorb can be used to control deadly inflammation and provide organ support.  Now with reimbursement, more patients will have access to our breakthrough CytoSorb therapy that adds a new dimension to blood purification."

Dr. Steiner praised the strategic collaboration with new distribution partner, Bıçakcılar Medical Devices. "Our partnership with Bıçakcılar was instrumental in obtaining national reimbursement and inclusion of CytoSorb® in the healthcare catalog of the DMO. We look forward to working more closely with them to leverage our new reimbursement and expand the Turkish market for our products." 

Bıçakcılar Medical Devices is the leading manufacturer of disposable medical products and OR Solutions in Turkey.  The company was established in 1959. Over the years, the Bıçakcılar brand has gained wide acceptance and established a tradition of continued reliability and customer satisfaction.

Dr. Souheil El Hakim, Chief Executive Officer of Bıçakcılar, emphasized the important alignment of both companies towards patient-centric solutions that are vital to improving clinical outcomes for critically ill patients in Turkey and beyond. "We believe that everyone deserves affordable and effective healthcare.  In critical care medicine specifically, we are able to distribute the most effective therapies with the help of our extensive production facilities.  At the same time, we are working to have a direct impact on healthcare outcomes.  With CytoSorbents, we have found one of the most innovative partners to help us achieve this, giving us the opportunity to fill our approach with even more life."

Turkey provides universal health care for approximately 95% of the nation's 84 million citizens, comparable in size to Germany.  There are more than 1,500 hospitals, where roughly 62% are public or university hospitals, and 38% are private.  Turkey has a large intensive care unit network, with one of the highest numbers of ICU beds per 100,000 population among developed nations at roughly 46, compared to 29 in the U.S. and 39 in Germany, for example.  Turkey is also a central hub for medical tourism in the region, attracting 1.7 million patients from outside of Turkey each year, particularly for surgical procedures such as cardiovascular, thoracic, plastic, orthopedic, and others. 

Bıçakcılar Medical is a 60-year-old company that has created a lot of "firsts" in Turkey where it was born. Over the years, expanding globally, Bıçakcılar Medical has helped to save lives around the world supplying the products that are crucial in healthcare. From medical disposables to OR Solutions, it stands out with two unique attributes: Quality control with zero tolerance for error and after sales service by its own experts, adding exceptional durability to its medical equipment. A focus on the "patient" is just one of the reasons many of its international and domestic customers have partnered with the company for over 20 years. With over 800 employees and many business partners, Bıçakcılar serves its customers by manufacturing and supplying innovative, reliable and environmentally friendly medical devices. Bıçakcılar is committed to assuring that everything it does benefits society and the environment while helping to save lives.

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in critical care and cardiac surgery through blood purification.  Its flagship 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