CytoSorbents and Aferetica Announce European Union Approval of the PerLife™ System and ECOS-300CY™ PerSorb™ Cartridge for Combined Perfusion and Purification of Solid Organs Dedicated to Transplant

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) and Aferetica have received European Union approval for their innovative PerLife™ ex vivo organ perfusion system and ECOS-300CY™ sorbent cartridge. This integrated system aims to enhance the preservation and quality of kidneys and livers prior to transplant. The commercial launch is planned for Italy this quarter. The PerLife system is designed to remove inflammatory mediators, thereby increasing the success rates of solid organ transplants amid rising global demand due to health crises like diabetes and obesity.

Positive

• EU approval for PerLife™ and ECOS-300CY™ enhances market credibility.
• The PerLife system could significantly improve organ transplant success rates.
• The collaboration with Aferetica positions CTSO favorably within the European market.

Negative

• None.

NEW JERSEY and BOLOGNA, Italy, Oct. 14, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO; USA) and Aferetica srl (Italy), two pioneers in intensive care immunotherapy and blood purification, announce the European Union approval of Aferetica's PerLife™ ex vivo organ perfusion system and CytoSorbents' ECOS-300CY™ sorbent cartridge for the removal of inflammatory mediators during ex vivo organ perfusion.  The integrated system was developed in concert to improve the preservation and quality of solid organs, like the kidneys and liver, following harvest and prior to transplant into a new recipient.  Aferetica and CytoSorbents have worked closely together to ensure mutual compatibility of their technologies and will introduce the PerLife System and PerSorb™ (ECOS-300CY) adsorber dedicated to Aferetica, with a commercial launch in Italy this quarter.

PerLife is a revolutionary, integrated, therapeutic system for organ transplant that is the first to provide both perfusion and purification of the kidney and the liver, following organ retrieval and before organ implantation. The platform integrates newly patented and innovative technologies creating an all-in-one machine capable of covering the broad range of temperature preservation techniques (Hypo-, normo-, and sub-normothermic) while incorporating the CytoSorbents ECOS-300CY perfusion cartridge to remove inflammatory mediators that can compromise the health and quality of the organs.  The main goal of combined therapies is to increase successful solid organ transplants by helping to preserve good organs, rehabilitate sub-optimally functioning ones, and to increase the overall pool of viable organs to meet the growing worldwide demand for transplanted organs.  Today, this need is being driven by record rates of kidney and liver failure caused by globally pervasive health crises such as the aging population, diabetes, hypertension, obesity, alcoholism, hepatitis, and non-alcoholic steatohepatitis (NASH), also called "fatty liver."

Dr. Mauro Atti, Chief Executive Officer of Aferetica, said, "With the creation of PerLife™ and its E.U. certification, we are now entering the commercial phase for organ perfusion and real-world clinical usage. This follows five years of development and fine-tuning, including a fruitful three-year partnership with CytoSorbents to develop and integrate a new sorbent technology that can help to purify, clean, and preserve solid organs collected for transplant.  Early studies conducted by some of the most prestigious Italian universities have demonstrated the vast potential of this combined system for organ transplant.  The PerLife™ system stands out among ex vivo organ perfusion systems because it offers the flexibility to perfuse organs over a wide range of temperatures, has been optimized to support the liver and kidneys which are the most frequently transplanted organs  worldwide, provides a constant flow of oxygen to the perfusion fluid, and it is integrated with CytoSorbents' ECOS-300CY sorbent to remove inflammatory mediators. After an initial launch in Italy, we plan to market our therapy all over the European Union and in other countries that accept E.U. approval."

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents said: "We are thrilled to collaborate with Aferetica as they prepare to enter the Italian market. The Italian market performs approximately 3,600 transplants per year with 6,000 patients on the waiting list, representing about 10% of the European market."  The ECOS-300CY cartridge will be included as part of the PerLife perfusion kit as the 'PerSorb' cartridge.  We believe that organ preservation and reconditioning is a key to increase organ availability. The lack of adequate oxygenation, the unavailability of nutrients, and the presence of inflammatory mediators can cause organ damage with consequent post-transplant complications. The feature-rich PerLife System has the ability to take ex vivo organ perfusion to a new level, particularly when combined with the seamlessly integrated ECOS-300CY "PerSorb" cartridge.  The goal of the PerSorb cartridge is to remove harmful inflammatory toxins from the perfusion fluid and to restore a more conducive environment for organ health that may extend the length of storage and the quality of organ function at the time of transplant.  The ability to provide high-quality organs capable of quickly regaining their function is expected to be an important factor in successful organ transplantation."

Viable organs for transplant are scarce, yet the number of patients awaiting transplant continues to grow globally, with more than 150,000 candidates waiting for transplants in Europe alone.  In 2019, 41,000 patients received solid organ transplants in the E.U., while 48,000 new patients were added to the transplant list and approximately 4% (or 6,000) died awaiting a transplant. As demand for donor organs continues to outpace availability and as patients run out of options, transplant centers are now supplementing viable organs with marginal ones.  However,  some studies suggest organs from this expanded donor pool have a higher risk of primary graft failure and organ rejection compared to "ideal donors."  Inflammatory mediators and cytokines, such as IL-6, appear to play a role in this progressive loss of function, and have been correlated with an increased risk of death in  recipients.  The PerLife platform and ECOS-300CY PerSorb cartridge have the potential to significantly change how organs are treated before transplant.

About Aferetic SRL

Aferetica was founded in January 2014 as an innovative start-up listed in the national register (Law 221/2012), within the Mirandola Science and Technology Park incubator.  In 2019, Aferetica became an innovative Small Medium Enterprise. The range of interventions include blood purification, therapeutic apheresis, and solid organ perfusion as an alternative or complement to expensive drugs and invasive systems, addressing enormous and diversified clinical fields such as Neurology, Autoimmune Diseases, Diabetology, Rheumatology, Nephrology, and Intensive Care.

Aferetica's intuitions and know-how come from decades of experience in Medical Devices of the founding partners.  These include Chief Executive Officer, Dr. Mauro Atti (former Scientific Director of Bellco), Chairman Stefano Rimondi (Past president of Assobiomedica), and Commercial Director William Pulga (former head of Bellco's Intensive care sector).  Aferetica has benefitted greatly from the extensive knowledge and experience contained in the Mirandola area, to open new frontiers and to conduct collaborative research using extracorporeal therapies to purify the blood, organs, and body.  The collaboration with CytoSorbents, and the distribution of CytoSorb in Italy, has been one of the most important.  Aferetica, which issued its first invoice in September 2014, closed 2019 with an income of over 4 million euros with plans to double sales by 2022.  For more information: http://www.aferetica.com

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 65 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 100,000 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. Army, 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™, VetResQ™, K⁺ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company's websites at http://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 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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CytoSorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com 

 

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SOURCE CytoSorbents Corporation

FAQ

What is the PerLife™ system approved by CTSO?

The PerLife™ system is an integrated organ perfusion system that improves the preservation of solid organs before transplantation.

When will the PerLife™ system be launched in Italy?

The commercial launch of the PerLife™ system in Italy is expected this quarter.

How does the ECOS-300CY™ cartridge benefit organ transplants?

The ECOS-300CY™ cartridge removes inflammatory mediators, improving organ function and transplant success rates.

What is CTSO's role in the organ perfusion market?

CTSO collaborates with Aferetica to provide advanced organ perfusion solutions in the growing transplant market.