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
Terumo Cardiovascular and CytoSorbents collaborate to commercialize CytoSorb in US. (Credit: FreeDigitalPhotos.net/dream designs.)
Terumo Cardiovascular, a global leader in cardiovascular surgery technologies and subsidiary of Japan-based Terumo Corporation, and CytoSorbents Corporation, 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 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.
Source: Company Press Release