Per Cytosorb 8k today (CTSO), Their filter has been highly successful inreducing inflamation in Covid-19 cases and allowing the patients to recover. They have emergency authorization for use in the US and are authorized for certain uses in the EU.
http://archive.fast-edgar.com//20200416/A8BZQ...SZ2Q2ZV22/
Disclosure: I am long CTSO.
Quote:As a result of the global outbreak of the COVID-19 pandemic, CytoSorbents Corporation (the “Company”) is filing this Current Report on Form 8-K to update certain trends and other disclosure contained in its filings with the Securities and Exchange Commission.
A significant problem relating to the COVID-19 pandemic is that an increasing number of COVID-19 patients are developing life-threatening complications, such as acute respiratory distress syndrome (ARDS), shock (i.e. a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections. The underlying cause for these complications is often a cytokine storm that results in a massive, systemic inflammatory response, leading to the damage of vital organs such as the lungs, heart, and kidneys, and ultimately multiple organ failure and death in many cases. The Company’s product, CytoSorb, has been used in more than 80,000 treatments as an approved treatment of cytokine storm in the European Union and is distributed in 58 countries around the world, where it has helped physicians control severe inflammation while helping to reverse shock and improve respiratory and other organ function.
The use of CytoSorb in patients infected with COVID-19 in Italy, China, Germany and France, among other countries, began around March 2020. Although CytoSorb does not kill or remove the virus, it has now been used in more than 200 COVID-19 patients to help treat cytokine storm and the related life-threatening complications in these countries. Based upon initial, preliminary verbal reports from physicians treating these complications, CytoSorb use has generally been associated with a marked reduction in cytokine storm and inflammation, improved lung function, weaning from mechanical ventilation, and a reversal of shock, though not all treatments have been successful in this critically-ill patient population that verges on death, particularly when used too late. Also based on these preliminary reports, CytoSorb has been specifically recommended in the Italy Brescia Renal COVID Task Force Guidelines to treat patients with severe COVID-19 infection and Stage 3 renal failure on continuous renal replacement therapy. CytoSorb has also been recommended in the National Treatment Guidelines from Panama for Adult COVID-19 Patients if patients have either refractory shock, or have severe or refractory respiratory failure requiring either high ventilator support or extracorporeal membrane oxygenation. In addition, the recommendation to treat cytokine storm with blood purification in COVID-19 infection has been included in the "Diagnosis and Treatment of New Coronavirus Pneumonia (7th Version)" by the National Health Commission in China.
The use of CytoSorb has not been approved in the U.S. by the U.S. Food and Drug Administration (“FDA”). However, under certain circumstances, investigational medical devices that have not yet been FDA-approved may be made available for emergency use in the U.S. under the FDA’s Expanded Access Program. On April 13, 2020, the Company announced that the FDA granted emergency use authorization (“EUA”) of CytoSorb for use in U.S. critically-ill patients infected with COVID-19. Under the EUA, CytoSorbents can make CytoSorb available, through commercial sales, to all hospitals in the U.S. for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit with confirmed or imminent respiratory failure who have early acute lung injury or ARDS, severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure. To date, the Company has been contacted by more than 100 U.S. hospitals concerning the potential use of CytoSorb for patients infected with COVID-19. The EUA will be effective until a declaration is made that the circumstances justifying the EUA have terminated or until the EUA is revoked.
To meet the growing demand for CytoSorb worldwide, the Company’s manufacturing facility is currently running 24 hours a day, seven days a week. The Company is seeking to scale its manufacturing, to subsidize its efforts to provide CytoSorb to hospitals for emergency use and to help fund a clinical study in COVID-19 patients.
http://archive.fast-edgar.com//20200416/A8BZQ...SZ2Q2ZV22/
Disclosure: I am long CTSO.
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