CytoSorbents Partners with InvoSurg and Surgical Partners to Commercialize CytoSorb® in the U.S. Northeast, Mid-Atlantic, and Florida under FDA Emergency Use Authorization for COVID-19
MONMOUTH JUNCTION, N.J., Aug. 17, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) 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 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 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.
Financial terms of these agreements have not been disclosed.
About InvoSurg Inc.
InvoSurg Inc. is a medical device distribution company with over ten years of experience in the cardiac surgery and extracorporeal life support space. InvoSurg is heavily focused on education and training with over 60% of the field team having strong clinical backgrounds with a core focus in cardiac perfusion. InvoSurg is dedicated to partnering with best-in-class industry leaders to provide its customers with innovative solutions to complex medical problems. For more information, please visit the Company's website at InvoSurg.com.
About Surgical Partners
Surgical Partners is a unique sales and marketing distribution partner for medical device manufactures. A proven 10+ year expertise provides our partners with access to high level relationships with hospitals and surgeons throughout Florida. Our highly trained, experienced and Certified Sales Team is the ultimate ambassador dedicated to the success of medical devices making a positive impact in patients' lives. For more information, please visit the Company's website at surgicalpartnersflorida.com.
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 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. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted U.S. FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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 more than $37 million from DARPA, the Defense Health Agency, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC), the U.S. Department of Health and Human Services, 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.
Forward-Looking Statements
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, including statements about our expected revenues and the impact of the COVID-19 pandemic on the Company, its operations and use of CytoSorb internationally, 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 5, 2020, 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 Contact:
Amy Vogel
Investor Relations
(732) 398-5394
[email protected]
Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
[email protected]
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
[email protected]
SOURCE CytoSorbents Corporation
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