US-based CytoSorbents Corporation and Italy’s Aferetica SRL collaborate to bring a new blood purification treatment, CytoSorb®, to the Italian medical device market.
Northern Italy is known for its art, cathedrals, and cuisine. But, Mirandola, the region that brought us opera and the Ferrari, is also known as Italy’s Biomedical Valley.
Incubated within the biomedical district of Mirandola, Aferetica SRL is a start-up specializing in blood purification devices. Hospitals use these devices to support procedures (e.g., organ transplants) and to treat critical illnesses (e.g., sepsis and autoimmune diseases).
Italy is the fourth largest country in Europe, with 60 million residents and annual healthcare spending of approximately $150 billion. It is the second largest consumer of medical devices and disposables in the European Union. Despite increasing bureaucratic barriers and payment delays, Italy remains the 4th largest medical technology industry in Western Europe and the 7th largest in world.
Aferetica SRL Named Exclusive Distributor of Innovative Blood Purification Technology
Recently, US-based CytoSorbents Corporation signed an exclusive distribution agreement with Aferetica SRL to distribute CytoSorb® in Italy for critical care applications.
Bringing new products to the Italian market is nothing new for Aferetica SRL. Aferetica SRL’s founders Mauro Atti and Stefano Rimondi have decades of experience in dialysis, intensive care, cardiology, and medical devices in general.
Aferetica SRL aims to be a catalyst for the creation of a network of clinicians, academics, researchers, industrialists, and institutions capable of creating, validating, and using apheresis therapies in clinical practice. While others in the biomedical technology industry develop blood purification techniques, Aferetica SRL seeks a more holistic and methodical therapy.
Sepsis usually develops from another medical condition, and is most common and most dangerous in older adults and those with weakened immune systems. Sepsis occurs when chemicals released into the bloodstream to fight an infection trigger inflammatory responses throughout the body.
This inflammation can trigger a cascade of changes that can damage multiple organ systems, causing them to fail. Sepsis progresses quickly, and is often not diagnosed until a patient develops septic shock, when blood pressure drops dramatically.
Patients with sepsis generally receive aggressive treatment in ICUs, where approximately half of them die. Mortality rates increase with the severity of sepsis. If no organ failure develops, the mortality rate is 19.9%. In severe sepsis cases, the mortality rate is 44.4%. The mortality rate of septic shock is 58.6%.
High-income countries are seeing an increasing incidence of sepsis, according to the World Health Organization. A 2012 study in the Journal of Global Health found no studies on the incidence of sepsis in developing countries, though it seems likely that these statistics would be at least similar or higher than in developing countries, where the incidence ranges from 22-240 cases per 100,000 inhabitants per year. In Italy, the incidence of sepsis is 25 cases per 100,000 inhabitants per year.
Innovative Device Removes Cytokines from Blood, Giving Physicians More Time to Identify the Source of the Infection
CytoSorbents Corporation’s flagship product, CytoSorb® is approved for use in the European Union (EU) as an extracorporeal cytokine adsorber. In conditions in which the risk of death is high, such as sepsis, burn injury, trauma, lung injury, and pancreatitis, CytoSorb® is used to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to complications including multiple organ failure.
Source: CytoSorbents Corporation
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. To treat sepsis, blood is pumped out of the body and through the CytoSorb® cartridge where cytokines are removed. The purified blood is then recirculated through the patient. CytoSorb® can be used with standard hemodialysis machines in any situation in which cytokines are elevated.
“The treatment opportunities with CytoSorb® in critical care are enormous,” Mr. Mauro Atti, Chief Executive Officer of Aferetica SRL, stated. “[The use of] extracorporeal blood purification to treat disease is common in Italy, particularly for complex conditions such as sepsis… I am amazed with the initial results we have seen with this easy-to-use therapy inside Italian hospitals and truly believe, with CytoSorb®, that we are introducing a therapy that gives real hope to critically-ill patients, their families, and medical professionals facing terrible odds."
The Global Market for CytoSorb®
With registration, CytoSorb® can also be sold outside of the E.U. in countries that accept European medical device approval. CytoSorb® is being sold directly in Germany, Austria and Switzerland, and marketed through distributors in the United Kingdom, Italy, Ireland, the Netherlands, the Middle East (including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman, Yemen, Iraq and Jordan), Turkey, Russia and Taiwan.