CytoSorbents Receives Renewal of CytoSorb® CE Mark Through May 2024 and Annual ISO 13485:2016 Certification Through September 2022
MONMOUTH JUNCTION, N.J., Aug. 15, 2019 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that CytoSorb has received renewal of its European Union CE Mark through May 2024and ISO 13485:2016 Full Quality Assurance System certification of its manufacturing facility through September 2022.
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, „I am happy to announce CytoSorbents successfully completed its CE Mark and ISO13485:2016 re-certification audits. These certificates cover CytoSorb and our new manufacturing facility commissioned in June 2018. The success of this renewal of the CE Mark and recent audit is a reflection of CytoSorbents‘ ongoing commitment to quality. I am very proud of our quality, manufacturing, and research teams that contributed to these accomplishments.“
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents Corporation stated, „We are pleased to have achieved these important milestones, enabling us to continue manufacturing, marketing and selling CytoSorb throughout all of our existing countries, and in future countries that accept E.U. regulatory approval through the next renewals. CytoSorb continues to grow in adoption and usage throughout the world, and is generating an increasing amount of new positive clinical data, because it is helping physicians stabilize and regain control of their patients in a wide variety of critical illnesses and complications of cardiac surgery. The patients that CytoSorb treats are among the sickest of the sick in the hospital, where no therapy in the past has been able to impact poor overall outcomes. We, our partners, and the growing number of physicians and healthcare workers around the world, have seen how CytoSorb is different, and are proud that CytoSorb has been used in more than 67,000 treatments, up from 46,000 a year ago, as a powerful therapy to help save lives. We are on a mission to make this therapy available to the tens of millions of patients each year who are dying or being disabled from life-threatening illnesses.“
Dr. Chan continued, „Having completed our strongest quarter ever in CytoSorb sales with an expansion of our blended product gross margins by 200 basis points to 76%, and with a solid cash position of approximately $20 million, we are confident in even stronger growth ahead, driven by the addition of many talented new people in sales, marketing, clinical, manufacturing, and quality, many of whom will start over the next several months. We are convinced that we are in the right place and time, with the right people, and the right product to drive further success of our company, and we are grateful to all of the people who have helped to support this company and make this therapy a reality.“
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb®is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the „cytokine storm“ or „cytokine release syndrome“ that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 67,000 human treatments to date.
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 nearly $26 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, 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 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, 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 7, 2019, 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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Cytosorbents Europe GmbH, headquartered in Berlin, is a wholly owned subsidiary of CytoSorbents Corporation of Monmouth Junction, New Jersey, USA, where the CytoSorb product is manufactured. CytoSorb is the company’s flagship product, backed by more than 30 patent families.
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