CytoSorbents Highlights Largest Published Case Series To Date Using CytoSorb in Critically Ill COVID-19 Patients
On Nov 25, 2020, CytoSorbents Corporation (NASDAQ: CTSO) announced the publication of the largest case series using its CytoSorb blood purification technology in critically ill COVID-19 patients. This study, published in Artificial Organs, assessed 50 patients requiring renal replacement therapy. The findings revealed a 70% survival rate at 28 days post-ICU admission, with statistically significant improvements in key inflammatory markers after treatment. The CEO highlighted the relevance of the study amid ongoing COVID-19 surges, emphasizing the need for effective therapies during the pandemic.
- 70% survival rate at 28 days for critically ill COVID-19 patients treated with CytoSorb.
- Statistically significant improvement in inflammatory markers post-treatment.
- CEO stresses the relevance of the findings during current COVID-19 surge.
- 30% non-response rate to CytoSorb therapy among patients.
- Non-responders had advanced thromboembolic disease, complicating treatment.
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.
In a recent publication in the peer-reviewed journal, Artificial Organs, entitled, "Continuous renal replacement therapy with the addition of CytoSorb® cartridge in critically ill patients with COVID-19 plus acute kidney injury: a case-series," Alharthy and colleagues report on the use of CytoSorb in all 50 critically ill COVID-19 patients that required renal replacement therapy for acute kidney injury at their institution during June and July of this year.
- 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
Key Parameters | Before CytoSorb | After CytoSorb |
Interleukin-6 (pg/mL) Normal range: 1-7 pg/mL | 612.85 ± 185.63 | 170.11 ± 77.78 |
Ferritin (ng/mL) 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 |
PaO2/FiO2 ratio <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 | 0 |
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 (
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
Dr. Chan continued, "Intravenous dexamethasone, as a treatment of virus-induced lung inflammation, has demonstrated reduced mortality in mechanically ventilated patients, from
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."
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 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
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, 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.
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