MONMOUTH JUNCTION, N.J., March 12, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, provided an update from its Chief Executive Officer, Dr. Phillip Chan, MD, PhD.
Dr. Phillip Chan stated, “As documented worldwide coronavirus cases surpass 125,000, we are witnessing a global escalation of activity to try to stem the tide of COVID-19 infection. The official World Health Organization (WHO) declaration of a formal pandemic, the lockdown on travel and non-essential businesses in Italy, and the U.S. ban on all travel from Europe, are just some examples. Coronavirus has also already begun to affect our own communities, with a shut down of schools, sporting events, conferences, and social gatherings. As testing in the U.S. becomes more available, the true extent of the spread of coronavirus will become clearer.
In discussions with physicians who are working in the epicenters of infection in Italy and China, the real problem with the COVID-19 pandemic is that serious and critically-ill patients are flooding hospitals, and overwhelming their ability to treat these patients. Intensive care units (ICU) are in gridlock and in many cases at the breaking point, as an increasing number of patients with life-threatening complications of COVID-19 infection such acute respiratory distress syndrome (ARDS), shock (i.e. a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections, occupy the limited number of ICU beds, and consume tremendous medical, equipment, and healthcare worker resources, with little hope of a quick recovery and ICU discharge.
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. Steroids are being used reflexively to try to control this inflammation, despite WHO recommendations against using steroids in COVID-19 infection, and evidence from other coronavirus infections (e.g. SARS and MERS) and influenza that its use can delay viral clearance and increase mortality.
This is why CytoSorb represents a potentially promising option in helping to treat these patients, and get them out of the ICU faster, thereby relieving this bottleneck. Although CytoSorb does not kill or remove the virus, it has been used in more than 80,000 treatments as an approved treatment of cytokine storm in the European Union and 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. And again, these complications are often the real reason patients die of COVID-19 infection.
Over the past two weeks, multiple patients with at least respiratory failure, shock, or kidney failure, in multiple hospitals in Wuhan, China have been treated with CytoSorb. Based on preliminary positive feedback on patient outcomes, we have responded to a request for additional devices and have now delivered a second shipment of CytoSorb devices to our partner in China, intended for new critically-ill COVID-19 patients.
In addition, we have learned of the first initial treatments of CytoSorb on COVID-19 patients in intensive care units in Italy. Though challenging to get feedback on how these patients have done, due to the overwhelming workload of the treating physicians, we hope to have more information soon. Meanwhile, we have also received an additional order from Iran, another country where coronavirus infection has been rapidly spreading.
Oddly in Germany, where CytoSorb has the greatest potential for COVID-19 treatment experience, the cases of coronavirus infection have been relatively mild, with Germany reporting more than 1,600 cases and only 3 deaths (0.2% mortality). This is in stark contrast to the U.S. with 1,257 cases and 38 deaths (3.0% mortality), and France, with 2,281 cases and 48 deaths (2.1% mortality). That said, German Chancellor Angela Merkel has warned that 60-70% of the population may get infected. Unfortunately, the reality is that there will be many opportunities to build treatment experience with CytoSorb in COVID-19 infection, not just in Germany, but wherever we sell CytoSorb.
There has been much discussion about the development of vaccines and anti-viral drugs for COVID-19. Unfortunately, a vaccine is not expected to be available until 12-18 months from now, far too late to impact the pandemic today. We welcome and applaud efforts to rapidly develop and evaluate anti-viral drugs that have activity against COVID-19, as these have the ability to reduce the severity of illness and potentially reduce the likelihood of an infected patient transmitting the virus to others. CytoSorb would work in synergy with these medications. That said, vaccines and anti-virals are not the full answer, as they do not treat the deadly complications of COVID-19 infection, as highlighted above. Seasonal influenza is just one example of this. Vaccines and anti-viral medications are readily available and used for the prevention and treatment of influenza, yet this season according to the Centers for Disease Control and Prevention (CDC), influenza was responsible for an estimated 34 million infections in the U.S., with 350,000 hospitalizations, resulting in 20,000 deaths – most of which were due to the complications of influenza infection that are nearly identical to those in COVID-19 infection.
Given the asymptomatic spread of COVID-19, the current lack of a vaccine and anti-viral therapies, and the fact the world population has no specific immunity to COVID-19, this pandemic has the potential to be devastating, causing a significant loss of life globally. Our goal is to make physicians aware of CytoSorb as a potential treatment option to help treat patients suffering from these deadly complications of severe COVID-19 infection, with the goal of speeding recovery, reducing the burden on ICUs, and saving lives.
As a final disclaimer, we currently have a strong cash balance, and have no need to raise capital at this time.”
CytoSorb is approved in the European Union and distributed in 58 countries around the world.
CytoSorb is not yet approved in the United States.
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 58 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. CytoSorb® has been used in more than 80,000 human treatments 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 $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) 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.
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 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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