Ann Arbor company and partner get FDA OK for COVID-19 treatment in hot spots

ANN ARBOR—Terumo Cardiovascular, the Ann Arbor-based cardiovascular surgery products provider, announced a collaboration with Monmouth Junction, N.J.-based CytoSorbents Corp.  (NASDAQ: CTSO), to sell the latter company’s product CytoSorb to hospitals in 10 COVID-19 hotspot states.

The states are Alabama, Arizona, California, Georgia, Louisiana, Mississippi, New Mexico, Oregon, Texas, and Washington.

The product is designed to treat cytokine storm, a dangerous complication in severe COVID-19 cases that causes severe inflammation and organ failure. 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.

“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,” said Terumo President and CEO Robert DeRyke.

Added Vincent Capponi, CytoSorbents president and COO: “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.”

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.

CytoSorbents 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 the Defense Advanced Research Projects Agency, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The company has numerous products under development based upon this blood purification technology protected by many issued U.S. and international patents and multiple applications pending. For more information, please visit www.cytosorbents.com and www.cytosorb.com.

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, with manufacturing operations in the U.S., Europe and Asia. It is one of several subsidiaries of Terumo Corp. of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.com.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.