CTSO stock moved higher in pre-market trading on March 25, 2020, after the company announced its product is being used to treat coronavirus patients.
“We are witnessing an acceleration of the COVID-19 pandemic as the total number of infected patients has surpassed 420,000 in 197 countries around the world,” stated Dr. Chan. “Italy has been the hardest hit, with the highest mortality of any major country. Physicians there describe the lung injury caused by COVID-19 pneumonia as the worst they have seen from any respiratory viral infection in recent history, leading to an atypically long 2-4 week dependence on mechanical ventilation, if critically-ill patients can survive that long. These comments mirror the experience reported in China and help to explain why many intensive care units (ICUs) have been overwhelmed with patients, and how a lack of resources such as mechanical ventilators and beds have led to a crisis in care.”
“Meanwhile, the United States is experiencing a dramatic surge of new cases this week, as New York and New York City have emerged as the epicenter of infection, accounting for approximately half, and a quarter of all cases, respectively, in the country. Already, hospitals in New York City are reporting a spike in hospitalized patients, as well as those with severe disease in the intensive care unit (ICU) requiring mechanical ventilation with rapidly progressive respiratory failure. It is expected to only worsen over the next several weeks. Meanwhile, this is a global phenomenon, with cases in Italy, Germany, Spain, and France still rising rapidly.”
“As the pandemic worsens, the use of CytoSorb in patients infected with COVID-19 has now begun. CytoSorb has now been used in more than 70 COVID-19 patients to help treat cytokine storm and life-threatening complications such as acute respiratory distress syndrome (ARDS) and shock in Italy, China, Germany, and France. Due to the crisis, the ability to obtain patient level data has been very limited. However, 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. Certainly not all treatments have been successful in this critically-ill patient population that verges on death, particularly when used too late. However, based on the initial positive results of the therapy, CytoSorb is now 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 (CRRT), published last week on the Italian Society of Nephrology website. As we mentioned previously, this follows the recommendation to treat cytokine storm with blood purification in COVID-19 infection by the National Health Commission in China in their treatment guidelines, entitled “Diagnosis and Treatment of New Coronavirus Pneumonia (7th Version).” In addition, based upon prior experience with CytoSorb in the treatment of critical illnesses, the soon to be posted National Treatment Guidelines from Panama for Adult COVID-19 patients now recommends the use of CytoSorb if patients have either refractory shock, or have severe or refractory respiratory failure requiring either high ventilator support or extracorporeal membrane oxygenation (ECMO – a machine that can oxygenate blood outside the body if the lungs become non-functional). CytoSorb has been used in thousands of ECMO treatments to date in non-COVID-19 patients around the world.”
“The initial positive results seen with the use of CytoSorb are very encouraging, particularly reversal of shock, improved lung function, and weaning from mechanical ventilation. Should we continue to see these benefits, each of these has the potential to save lives and reduce the length of stay in the ICU – the two key objectives that will make the difference in this COVID-19 pandemic between a manageable tragedy versus an abject disaster in the U.S. and other countries worldwide.”
“These preliminary results are also in-line with our expectations, given all of our clinical experience in treating shock, ARDS, and other complications of cytokine storm in other diseases. The role of cytokine storm and hyperinflammation on the severity of COVID-19 pneumonia was recently corroborated in an article entitled, “Clinical predictors of mortality due to COVID-19 based on an analysis of data from 150 patients from Wuhan, China” recently published in the journal, Intensive Care Medicine. In this paper, Ruan and colleagues documented very high concentrations of inflammatory biomarkers such as C-reactive protein, ferritin, and IL-6 in patients who died, and concluded “The results obtained from this study also suggest that COVID-19 mortality might be due to virus-activated “cytokine storm syndrome” or fulminant myocarditis [inflammation of the heart].”
“In the U.S., we seek to do our best to help critically-ill patients here, as we are doing overseas. Investigational medical devices in the U.S. that have not yet been FDA-approved, can be made available for emergency use under an already established Expanded Access Program by the FDA. The program is designed to provide potential investigational treatment alternatives to patients with immediately life-threatening conditions that have exhausted current standard of care therapies, where the benefit justifies the potential risk, and who will likely die if nothing else is done. By definition, these are treatments of “last resort,” have a low chance of success, and are typically provided only on a case-by-case basis. We have donated CytoSorb devices to patients in the U.S. in multiple emergency use cases over the years. That said, within the past week, we have received many unsolicited requests for emergency use from hospitals all over the country and are in discussions with the FDA on how to streamline this process, enable access of the CytoSorb technology to as many U.S. hospitals in the least burdensome way possible, treat patients earlier in the disease progression to have the best chance of success, and to collect patient-level data that can be used to optimize treatment for future patients and potentially support fast-track regulatory status. Meanwhile, we continue to update BARDA and the U.S. Joint COVID-19 Task Force with our progress. We seek support to scale our manufacturing, to subsidize our efforts to provide CytoSorb to hospitals for emergency use, and to help fund a clinical study in COVID-19 patients.”
“Finally, to meet the growing demand for CytoSorb worldwide, our manufacturing facility is currently running 24 hours a day, seven days a week. As an essential business that manufactures a life-saving therapy, we are not affected by the current New Jersey lock-down restrictions. We have developed contingency plans as a way to stay flexible in a rapidly changing environment and have taken precautions, as most businesses have, to protect and safeguard our employees, including mandatory work-at-home for non-essential employees. On behalf of the management team, Board of Directors, and shareholders, I want to take this opportunity to thank all of our employees, particularly those involved in ensuring the supply of CytoSorb to markets all over the world, for their outstanding work and extraordinary dedication during these challenging times.”
CytoSorb is approved in the European Union and distributed in 58 countries around the world.
CytoSorb is not yet approved in the United States.