CytoSorbents And Humedics Announce Theranostic Collaboration in the Field of Liver Disease

PRINCETON, N.J., July 11, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, and Humedics GmbH, a leader in non-invasive liver function measurement, have announced a theranostic collaboration in the field of liver disease.

• CytoSorbents’ CytoSorb^® blood purification technology is expanding the dimension of blood purification as the only E.U. approved extracorporeal liver support therapy specifically approved to remove both bilirubin, a key liver toxin that accumulates during liver dysfunction and failure, and cytokines, where cytokine storm is often the trigger or exacerbating factor in acute and acute-on-chronic liver disease. CytoSorb is easy and quick to setup and use, and removes other liver toxins such as bile acids and a wide range of inflammatory mediators. CytoSorb has been used for this application and many others in more than 200,000 human treatments in 75 countries around the world to date.
• Humedics is the pioneer of LiMAx^®, a rapid and precise E.U. approved diagnostic using its innovative breath analysis technology to quantitatively assess liver function. This easy-to-use bedside test provides doctors with accurate information to both monitor liver function in compromised patients longitudinally, and to support clinical decisions, such as the need to initiate extracorporeal liver support in critically ill patients, or the extent of liver resection in cancer patients with liver involvement. LiMAx has already been used on thousands of patients in Europe.

CytoSorbents and Humedics will collaborate on a joint product promotion and comarketing program aimed at increasing market awareness, adoption, usage, and sales of their respective technologies in the liver field. A key goal is to generate new customer leads for both CytoSorb and LiMAx through cross-training and selling amongst the companies’ combined sales teams at relevant accounts. The program will commence immediately starting in Germany, the United Kingdom, France, Austria, Switzerland, Belgium, Netherlands, Luxembourg, Finland, Norway, Sweden, and Poland. CytoSorbents and Humedics also plan to work together to bring new innovative solutions to the market which may include future collaboration opportunities in clinical studies, new therapeutic areas and indications, and new product concepts.

“Acute and chronic liver disease is a massive and growing problem throughout the world, afflicting 1 in every 11 people,” said Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents. “These illnesses are often associated with untreated excessive levels of cytokines, bilirubin, and other liver toxins that can worsen liver and other organ dysfunction. Today, there are limited treatment options available that are typically not utilized due to poor or inadequate efficacy, usability, and high costs. We believe CytoSorb addresses these issues, which represents a significant potential market opportunity for us. We are pleased to team with Humedics to develop a much more impactful personalized medicine strategy to diagnose, monitor, and treat liver disease with our combined theranostics approach.”

Dr. Ralf Kohnen, Chief Business Officer of Humedics, commented, “Our proprietary LiMAx breath analysis technology provides liver surgeons, hepatologists and other liver specialists the ability to easily assess liver function capacity. LiMAx produces a quantitative measure of maximal liver function, revealing liver metabolic function at the cellular level in real time, which correlates with liver disease severity. This information can be used by clinicians to monitor the efficacy of different therapies, predict prognoses, and to plan hepatic resections in liver cancer to ensure that the remaining liver has sufficient function. We view this collaboration with CytoSorbents as a natural evolution of our collective approaches and look forward to the synergy we can create in the marketplace.”

“This program has the potential to benefit both companies by enabling them to accelerate the introduction of innovative new diagnostic and therapeutic product offerings for hepatologists and liver support specialists that are dealing with the millions of patients suffering from liver disease each day,” stated Chris Cramer, Senior Vice President of Business Development for CytoSorbents. “This is a great opportunity to rapidly bring the benefits of LiMAx and our CytoSorb therapy to whole new segment of customers that may not yet know about these products.”

The financial terms of this agreement have not been disclosed.

About Humedics GmbH

Humedics, based in Berlin, focuses on rapid and precise liver function measurement using LiMAx, its innovative breath analysis technology. This easy-to-use bedside test provides doctors with accurate information to support decision making in tailoring the medical treatment to the individual level of each patient and to improve patient outcomes. LiMAx has already been used on thousands of patients and the company is currently expanding its operation globally.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb^®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q1 2023, more than 203,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

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 approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), 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 marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY^®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ^®, K⁺ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, 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, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, 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 9, 2023, 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.

Please Click to Follow Us on Facebook and Twitter

Contacts Humedics GmbH

Bundesallee 23
10717 Berlin, Germany
Phone +49 30 629 39 55-0
Fax +49 30 629 39 55-30
info@humedics.de

CytoSorbents Corporation Contact:
Kathleen Bloch, Interim CFO
(732) 398-5429
kbloch@cytosorbents.com

CytoSorbents Europe GmbH:
Josephine Kraus
PA by Dr. Christian Steiner
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com