Editor: What To Know
- 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.
- Kenneth Shann, CCP, Director of Business Development and Training at InvoSurg stated, “We are thrilled to add the CytoSorb cytokine adsorber to our extensive portfolio in order to provide solutions to our customers and their sickest patients battling COVID-19.
- CytoSorb has been authorized by FDA under an EUA for use in COVID-19 patients, 18 years of age or older in the intensive care unit with imminent or confirmed respiratory failure.
CytoSorbents has entered into separate agreements with InvoSurg Inc. and Surgical Partners to commercialize CytoSorb® under its FDA Emergency Use Authorization (EUA) in adult, critically-ill, COVID-19 patients with imminent or confirmed respiratory failure. Covering 15 states, Surgical Partners and InvoSurg will work with CytoSorbents to sell and distribute CytoSorb in Florida, and the Northeast and the Mid-Atlantic United States, from Maine to Virginia, respectively.These agreements follow a very positive initial reception and usage of CytoSorb in the U.S. after FDA Emergency Use Authorization of CytoSorb was granted in April 2020.
CytoSorbents is now aggressively expanding CytoSorb availability, marketing, and sales opportunities across the U.S. to help address the current and expected future waves of COVID-19 infection in the country.
Mr. Kenneth Shann, CCP, Director of Business Development and Training at InvoSurg stated, “We are thrilled to add the CytoSorb cytokine adsorber to our extensive portfolio in order to provide solutions to our customers and their sickest patients battling COVID-19.”
Mr. Bo Arble, Vice President of Surgical Partners stated, “COVID-19 continues to be a major challenge here in Florida. COVID-19 patients that are admitted to the ICU with imminent or confirmed respiratory failure generally have poor outcomes and can be difficult to treat. With the availability of CytoSorb under FDA EUA, we now have an exciting treatment option to potentially help these patients by removing excessive cytokines, or cytokine storm, from the bloodstream.”
Mr. Chris Cramer, Vice President of Business Development of CytoSorbents stated, “CytoSorb is the only FDA EUA blood purification technology to target cytokine storm reduction using CytoSorbents’ proprietary, highly biocompatible polymer beads. These beads combine more than 7 football fields of surface area in a single, easy-to-use, whole blood cytokine adsorber. We believe CytoSorb can play an important role in helping front-line physicians and healthcare workers better manage their COVID-19 patients. We are excited to work with Surgical Partners and InvoSurg to bring our therapy to more hospitals here in the United States.”
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents said, “Physicians have told us that they need better treatment options to help them regain control of their critically-ill COVID-19 patients. Partnerships like these with InvoSurg and Surgical Partners, are intended to bring CytoSorb rapidly to physicians and COVID-19 patients in the broader U.S. market in a timely and cost-effective manner. CytoSorb has been used in more than 1,200 COVID-19 patients worldwide. CytoSorb is plug-and-play compatible with a wide range of blood pumps that exist in hospitals today including hemoperfusion, dialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines. We are very proud to begin working with Surgical Partners and InvoSurg to bring CytoSorb directly to these areas of the United States that have been hard hit by COVID-19.”
CytoSorb has been authorized by FDA under an 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.
Financial terms of these agreements have not been disclosed.
