Early CytoSorb Initiation Improves Hemodynamic Stabilization and Survival in New Septic Shock Study

MONMOUTH JUNCTION, N.J., Dec. 9, 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 a 'genetic' matched analysis evaluating the early initiation of CytoSorb in critically ill patients with septic shock.

In a new publication in the peer-reviewed journal, Biomedicines, entitled, "Hemoadsorption with CytoSorb in Septic Shock Reduces Catecholamine Requirements and In-Hospital Mortality: A Single-Center Retrospective 'Genetic' Matched Analysis," Rugg and colleagues report on the outcomes with early use of CytoSorb in 42 critically ill septic shock patients requiring renal replacement therapy compared to those from 42 matched controls. 

• Study population was comprised of ICU patients with either primary or secondary sepsis from any source requiring renal replacement therapy treated with CytoSorb (n=42) compared to carefully selected controls not treated with CytoSorb (n=42), identified by generalized propensity-score and Mahalanobis distance matching ('genetic' matching)
• Age was similar in the two groups (64 vs. 68, p=ns), while baseline Sequential Organ Failure Assessment (SOFA) score was slightly but significantly higher in the CytoSorb group compared with controls (13 vs. 12, p=0.02), consistent with predicted mortality >60%
• Baseline norepinephrine requirements were also significantly higher in the CytoSorb group compared with controls (0.52 vs 0.25 µg/kg/min, p=0.01) while the remaining demographics and baseline characteristics were well-balanced between the two groups
• Importantly, CytoSorb therapy was started early (median 21.4 hours after ICU admission) with 90% of patients receiving a single 24-hour treatment
• All patients received additional therapies according to standard of care

In this retrospective single center "genetic" matched analysis, treatment with CytoSorb was associated with rapid and significant (>50%) reduction in norepinephrine requirements in the first 24 hours while there was no change in norepinephrine requirements in the control group. Importantly, mortality rates were significantly lower in the CytoSorb group compared with the matched controls (21.4% vs. 47.6%, p=0.029 for 28-day mortality; 35.7% vs. 61.9%, p=0.015 for in-hospital mortality).

The mortality benefit observed by Rugg et al. is highly consistent with the previous publication by Brouwer et al. who also reported significant mortality reductions with CytoSorb in a similar ICU septic shock population requiring renal replacement therapy. Specifically, Brouwer et al. utilized the validated stabilized inverse probability of treatment weights (sIPTW) methodology to account for baseline differences between groups, and reported a reduction in 28-day mortality from 72% in the control group to 53% for the CytoSorb treated group (p = 0.038).  Importantly, both studies identified very high baseline lactate levels as predictors of poor outcomes, suggesting that earlier intervention with CytoSorb, prior to protracted organ dysfunction or failure, may be the appropriate strategy.

Rugg et al. concluded, "The addition of extracorporeal hemoadsorption via CytoSorb to standard care in septic shock patients requiring renal replacement therapy approximately halved catecholamine requirements within 24 hours. In-hospital as well as 28-day mortality were reduced significantly when compared to a generalized propensity-score and Mahalanobis distance matched group." This mirrors the conclusion from Brouwer et al. where they stated, "We have shown, to our knowledge, in the largest cohort of septic shock patients to date, that CytoSorb treatment may lead to an improved 28-day survival compared to CRRT alone, both on basis of observed versus predicted mortality rates as well as by IPTW."

Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "This new publication suggests that early initiation of CytoSorb (<24 hours from ICU admission) leads to a significant survival benefit in critically ill septic shock patients on renal replacement therapy. The results add to the increasing body of evidence of enhanced survival with CytoSorb in a multitude of critical clinical scenarios. Some examples include refractory shock, extremely sick COVID-19 patients, and patients requiring extracorporeal membrane oxygenation (ECMO). We observe that these benefits tend to be maximized with early initiation of therapy and before establishment of irreversible end organ damage. Finally, we remain steadfast in our commitment to high quality evidence generation and are pleased to announce that the company-sponsored PROCYSS trial (Prospective, Randomized, cOntrolled Trial using CYtosorb in refractory Septic Shock) is scheduled to commence enrollment in Germany in Q1 2021."

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.

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-RBC™, 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.

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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