MONMOUTH JUNCTION, N.J., Nov. 25, 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, highlights the publication of the largest case series using CytoSorb in critically ill COVID-19 patients to date.
On ICU admission, the average age was 49.6 ± 8.9 years with a mean Acute Physiology and Chronic Health Evaluation II (APACHE 2) score of 22.5 ± 1.1, conferring a mortality risk of greater than 40%
All of these patients were hyperinflamed and all had multiple organ failure including respiratory failure requiring mechanical ventilation, acute kidney injury requiring renal replacement therapy, and septic shock requiring the use of vasopressors. 24% (12/50) had documented pulmonary emboli, or blood clots in the lung, by CT scan, another independent mortality risk factor
Patients were treated continuously with CytoSorb and continuous renal replacement therapy (CRRT), exchanging the CytoSorb cartridge every 24 hours, until the achievement of all of the following: normalization of oxygenation, reversal of shock without the need for vasopressors, and the absence of electrolyte and metabolic abnormalities
In addition to CytoSorb, all patients received standard of care therapy including low tidal volume ventilation, prone positioning, antibiotics, steroids, and prophylactic anticoagulation, with empiric ribavirin and interferon beta-1b.
In this retrospective case series, 28-day survival post-ICU admission was 70%. Survivors averaged 2 ± 1 CytoSorb treatments to achieve statistically significant improvements in a wide range of inflammatory and clinical parameters, compared to before CytoSorb treatment (p<0.05; see table below, presented as mean ± standard deviation).
Normal range: 1-7 pg/mL
612.85 ± 185.63
170.11 ± 77.78
Normal range: 23-336 ng/mL
602.34 ± 142.18
296.46 ± 62.93
C-reactive protein (mg/L)
Normal range: 0-5 mg/L
145.4 ± 98.3
43.6 ± 26.2
<100 severe; 101-200 moderate; 201-300 mild ARDS
113 ± 34.68
303.43 ± 37.41
Noradrenaline infusion rate (mcg/kg/min)
0.97 ± 0.16
Serum lactate (mmol/l)
Normal range: 1-2.5 mmol/L
6.77 ± 2.56
2.17 ± 0.79
Urine output (ml/d)
119.17 ± 73.43
997.6 ± 273.34
*ARDS (Acute respiratory distress syndrome)
All survivors were successfully weaned from mechanical ventilation and vasopressors and discharged from the hospital or rehabilitation to home by 32 ± 12 days post-ICU admission. Non-survivors (30%) did not respond to CytoSorb therapy and had progressive disease. Non-responders had evidence of generally greater blood clot burden and more advanced thromboembolic disease upon ICU admission, with average D-dimers (degradation byproducts of blood clots) of 3,940 ± 1,780 ng/mL compared to 2,860 ± 780 ng/mL in survivors. In addition, patients with pulmonary emboli were more likely to die (p<0.05), a common finding in approximately half of all deaths. Given that cytokine reduction does not dissolve blood clots, it could explain the lack of response to CytoSorb therapy in these patients, and supports the concept of earlier intervention with anticoagulation and CytoSorb to mitigate blood clot formation.
The authors concluded that, "In this retrospective case-series, CRRT with the CytoSorb® cartridge provided a safe rescue therapy in life-threatening COVID-19 with associated AKI, ARDS, sepsis, and hyperinflammation."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "This new publication on the successful use of CytoSorb in a large cohort of extremely sick COVID-19 patients, along with new treatment insights, is very timely. New COVID-19 infections continue to surge worldwide, with the U.S., Europe, India, Russia, and Latin America reporting the most daily cases. The severity of illness in the current surge was initially low, but as numbers mount, so too have hospitalizations, intensive care unit (ICU) admissions, and deaths. Severe respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) has been the major cause of death throughout the pandemic, though shock, kidney failure, and sudden cardiac death are also common complications. Unfortunately, the promising COVID-19 vaccines from Pfizer, Moderna, and Astra Zeneca will likely come too late to impact the current surge, with far less than 10% of the U.S. population expected to be vaccinated by the end of this year."
Dr. Chan continued, "Intravenous dexamethasone, as a treatment of virus-induced lung inflammation, has demonstrated reduced mortality in mechanically ventilated patients, from 41% to 29%, in the U.K. RECOVERY study. However, that one in every three to every four people still die despite dexamethasone highlights the complexity of COVID-19 infection and the need for additional therapies. In the RECOVERY study, patients were generally older than those reported by Alharthy, but they were also far less complex, with no mention of other organ failure besides the lungs. In the current Alharthy study, patients not only had lung failure, they also had acute kidney injury requiring CRRT and septic shock, all of which significantly increases the risk of death. Yet the mortality in both studies was comparable, at approximately 30%, suggesting the potential additive benefit of CytoSorb. We look to corroborate these observations in ongoing studies and our actively enrolling CTC COVID-19 Registry."
Dr. Chan concluded, "At Thanksgiving, let us pause to remember those we have lost, give thanks to those who have worked to keep us safe, and to be thankful for the continued health of those close to us. At CytoSorbents, we wish you and your families a safe and happy holiday season."
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 66 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® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 110,000 human treatments 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 FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
The CytoSorb device has been authorized by FDA under an Emergency Use Authorization. It has neither been cleared nor approved for the indication to treat patients with COVID-19 Infection. The EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.
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 $38 million from DARPA, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), 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 ECOS-300CY™, CytoSorb-XL™, HemoDefend-RGC™, HemoDefend-BGA™, 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, including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones, 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, 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 Current Reports on Form 8-K, 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, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. 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.