August 24, 2020
ANN ARBOR, Mich. and MONMOUTH JUNCTION, N.J. -- August 24, 2020 -- Terumo Cardiovascular, a global leader in cardiovascular surgery technologies and subsidiary of Japan-based Terumo Corporation (TSE: 4543), and CytoSorbents Corporation (NASDAQ: CTSO), manufacturer of the CytoSorb® extracorporeal cytokine adsorber, announced an initial collaboration to exclusively sell CytoSorb to hospitals in ten U.S. COVID-19 hotspot states including Alabama, Arizona, California, Georgia, Louisiana, Mississippi, New Mexico, Oregon, Texas, and Washington. CytoSorb previously received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for use in adult, critically-ill COVID-19 patients with imminent or confirmed respiratory failure.
Under the initial terms of the agreement, Terumo Cardiovascular will ensure hospitals in the defined hot-spot states have access to the CytoSorb therapy for use in critically-ill COVID-19 patients that meet strict criteria under CytoSorbents' EUA. CytoSorbents will provide all primary clinical and technical training, customer support, and product fulfillment.
Terumo Cardiovascular supplies several perfusion products that may be used in extracorporeal membrane oxygenation (ECMO) in accordance with FDA's EUA guidance issued in April 2020. These include its CAPIOX® FX25 Oxygenator, CDI® 550 Blood Parameter Monitoring System, and Terumo® Advanced Perfusion System 1 heart-lung machine. The combination of ECMO and CytoSorb is an ideal pairing, enabling gas exchange and cytokine storm reduction, allowing the lungs to rest and potentially helping to reduce the time on mechanical lung support.
Robert DeRyke, President and CEO of Terumo Cardiovascular, commented, "We are excited to expand our collaboration with CytoSorbents to the United States. We believe our strong relationships with cardiac surgeons, perfusionists, and other front-line healthcare workers will help to bring this innovative therapy to critically-ill COVID-19 patients in these hard-hit areas."
Vincent Capponi, President and Chief Operating Officer of CytoSorbents, said, "We are pleased to work with Terumo Cardiovascular to significantly increase awareness and availability of CytoSorb to hospitals in the Southern and West Coast U.S. where COVID-19 continues to surge. To date, CytoSorb has been used to treat over 1,200 COVID-19 patients in over 30 countries, including the U.S. under our FDA EUA. This is gratifying because we manufacture CytoSorb right here in the United States. CytoSorb is compatible with the vast majority of blood pumps in hospitals today, including hemoperfusion, dialysis, continuous renal replacement therapy (CRRT), and ECMO machines. In each case, CytoSorb works to reduce cytokine storm that has been observed in many critically-ill COVID-19 patients. This gives doctors broad flexibility on how to treat their patients."
Chris Cramer, Vice President of Business Development of CytoSorbents stated, "This partnership with Terumo Cardiovascular takes on even greater importance as hospital admissions due to severe COVID-19 infections continue to rise rapidly in certain parts of the United States. Given the high mortality of mechanically ventilated patients, alternative treatment options, like CytoSorb, are desperately needed. We plan to leverage the extensive experience gained from working closely together in Europe for the past several years, with Terumo's outstanding U.S. sales organization to drive greater awareness and usage of CytoSorb, rapidly access customers, and help as many patients as we can in these COVID-19 hotspot states."
CytoSorb has been authorized by FDA under an Emergency Use Authorization (EUA) for use in COVID-19 patients, 18 years of age or older in the intensive care unit with imminent or confirmed respiratory failure. It has neither been approved nor cleared for the indication to treat patients with COVID-19 infection. The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device under Section 564(b)(l) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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 65 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. More than 100,000 CytoSorb® treatments have been delivered 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 $37 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), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) 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.
Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, Michigan, with manufacturing operations in the U.S., Europe and Asia. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.com
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for nearly 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large.
Corporate Communication Dept., Terumo Corporation
(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.