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About CytoSorbents, CytoSorb, and HemoDefend

CytoSorbents Corporation (NASDAQ: CTSO) is a New Jersey-based, critical care immunotherapy company specializing in blood purification to control deadly inflammation in critically-ill and cardiac surgery patients. The company’s flagship product, CytoSorb®, is approved in the European Union with distribution in 39 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury, and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death and cost of treatment are extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used safely in more than 14,000 human treatments to date.

CytoSorbents’ blood purification technologies are based on advanced, biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Each polymer bead, approximately the size of a grain of salt, contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at CytoSorbents’ ISO 13485 certified manufacturing facility in New Jersey. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL, HemoDefend™, ContrastSorb, DrugSorb, and others.

CytoSorb®

CytoSorb® is approved for sale in all 28 countries of the European Union (E.U.) as an extracorporeal cytokine adsorber, designed to control deadly systemic inflammation by reducing excessive cytokines, bacterial toxins, and many other factors from blood that “fuel the fire” of inflammation. Left unchecked, this uncontrolled inflammation can lead to organ injury, organ failure, and in many cases, death of the patient. The blood purification cartridge can be used with most kinds of extracorporeal blood pumps including standard hemodialysis machines, continuous renal replacement (CRRT) machines, heart-lung machines, and extracorporeal membrane oxygenation (ECMO) machines, in any situation where cytokines are elevated. This includes a diverse range of conditions where excessive cytokines and other inflammatory toxins are driving a potentially dangerous inflammatory response. These include acute critical illnesses such as sepsis and infection, burn injury, trauma, acute respiratory distress syndrome, severe acute pancreatitis, liver failure, influenza, cytokine release syndrome in CAR T-cell immunotherapy, and complications of cardiac surgery, as well as in other more chronic diseases such as cancer, cancer cachexia, autoimmune diseases, and others. CytoSorb® is also being used intra-operatively during open heart surgery in a bypass circuit in a heart-lung machine to pre-emptively reduce inflammatory mediators such as cytokines, activated complement, and plasma free hemoglobin that are generated during the surgery and can lead to post-operative inflammation and organ failure. CytoSorb® has been used in more than 14,000 human treatments to date and have been credited with saving many lives.

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, Spain, Portugal, the Netherlands, the Middle East (including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman, Yemen, Iraq, Iran, and Jordan), Israel, Turkey, Russia, Australia, New Zealand, Vietnam, and many other countries.

Our strategic partner Fresenius Medical Care, the largest dialysis company in the world, is currently distributing CytoSorb® in France, Norway, Finland, Sweden, Denmark and Poland for critical care applications. Terumo Cardiovascular, a global leader in cardiac and vascular surgery, has also partnered with us to exclusively distribute CytoSorb® for cardiac surgery applications in France, Norway, Sweden, Finland, Denmark, and Iceland. CytoSorb® is currently also being sold in India, Sri Lanka, and select emerging markets through our strategic partner, Biocon Ltd, India’s largest biopharmaceutical company.

There are more than 55 investigator-initiated studies in various stages of process in Europe and Asia using CytoSorb® in a wide variety of applications, with more than a third enrolling patients, and with a number already completed. In addition, the International CytoSorb® Registry has been established to collect and analyze treatment data from all over the world, and is being independently managed by the Center of Clinical Studies at the University of Jena, Germany.

The company is currently completing its 40-patient randomized, controlled, U.S. based REFRESH (REduction of FREe Hemoglobin) I cardiac surgery safety and feasibility trial, using CytoSorb® intra-operatively during elective, non-emergent complex cardiac surgery. If successful, the trial would be the basis of a pivotal REFRESH 2 trial, intended to achieve registration and approval of CytoSorb® in the U.S. for the application of cardiac surgery. The company is also conducting a 30-patient randomized controlled trial in patients with trauma and rhabdomyolysis, funded by the U.S. Air Force.

HemoDefend

HemoDefend™ is a development-stage blood purification technology platform for the blood transfusion industry intended to reduce transfusion reactions and safeguard the quality and safety of blood products. The HemoDefend technology utilizes the Company’s polymer bead technology to remove many substances, such as antibodies, free hemoglobin, potassium, and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions.

The Future of Blood Purification is Now

CytoSorb® and HemoDefend™ are just two of a number of different resins the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, removal of IV contrast, treatment of drug intoxication, and others. Additional information is available in the Investor Relations section.

CytoSorbents and its technology has garnered more than $18 million in support from the U.S. Government. DARPA, or the Defense Advanced Research Projects Agency, as part of its “Dialysis-Like Therapeutics” program to treat sepsis, awarded CytoSorbents a $3.8 million five year contract to develop cytokine and toxin binders for the program. CytoSorbents collaborates with groups such as Battelle Laboratories, Harvard’s Wyss Institute, NxStage Medical (NASDAQ: NXTM), Massachusetts Institute of Technology, and others in this program. CytoSorbents was also awarded $1.65 million by the U.S. Army in a Phase I, Phase II and Phase II Enhancement SBIR contract to develop its blood purification technologies to treat burn injury and trauma. The U.S. Air Force is also funding an FDA-approved, 30-patient randomized controlled human pilot study using CytoSorb® to treat trauma patients with rhabdomyolysis that has begun. CytoSorbents has also been awarded $1.7 million in Phase I and II SBIR contracts from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH) and US Special Operations Command (USSOCOM) to further develop its HemoDefend™ technology for blood transfusions.

CytoSorbents operates through its wholly-owned subsidiary, CytoSorbents Medical Inc. (fka CytoSorbents Inc.), and conducts its European business through its wholly-owned subsidiary, CytoSorbents Europe GmbH. CytoSorbents Corporation converted from a Nevada Corporation to a Delaware Corporation in December 2014.

 

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CTSO News: Statement of Changes in Beneficial Ownership (4) 01/18/2018 05:24:15 PM
CTSO News: Current Report Filing (8-k) 01/09/2018 02:04:25 PM
CTSO News: Current Report Filing (8-k) 12/26/2017 06:41:44 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 12/08/2017 04:13:55 PM
CTSO News: Current Report Filing (8-k) 11/13/2017 06:04:58 AM
PostSubject
#10804   Recent evidence suggest that IL-6 is a central berthabluefish1 01/20/18 11:06:59 AM
#10803   LARGEST CORPORATE NOT LARGEST HOLDERS MORE LARGER PRIVATE Burnttoast247 01/20/18 11:02:13 AM
#10802   Cytosorbents Corporation, Inst Holders, 4Q 2017 dah174174 01/20/18 10:13:08 AM
#10801   Inflammation is a big factor in Cancer.Will see!IMO berthabluefish1 01/19/18 03:10:07 PM
#10800   i was told last year that cancer therapy Psuforlife 01/19/18 11:13:40 AM
#10799   caesare, you posted about the upcoming inflection point, biotech48 01/19/18 09:57:47 AM
#10798   Past months trading suggest your correct regarding upward Burnttoast247 01/19/18 08:00:28 AM
#10797   Good Sport: if your conclusion is right or caesare74 01/19/18 07:08:22 AM
#10796   The success fee is on $10 million not ping_pow_princess 01/19/18 12:06:35 AM
#10793   success fee attached to Bank loan is peanuts Burnttoast247 01/18/18 02:41:29 PM
#10792   Unfortunately, this continues to be a more aligned pearsby09 01/18/18 02:13:33 PM
#10791   Under $7.50 and those 4000+ call options are orangecat 01/18/18 01:14:05 PM
#10790   I do not mind the buying opportunity, but badgercat 01/18/18 12:34:20 PM
#10789   I just spoke to a source who said Good Sport 01/18/18 12:29:00 PM
#10788   Very interesting, Fantastic case studies and news CTSO Burnttoast247 01/17/18 04:36:49 PM
#10787   Really? LOL....me too have only core position. 5K SABAI 01/17/18 04:11:31 PM
#10786   For the first time I have become very pearsby09 01/17/18 03:08:47 PM
#10785   Biocon:Cytosorb saved the lives of 7 critically ill berthabluefish1 01/17/18 03:05:24 PM
#10784   17.49, on Feb 16, subsequent to EUA approval, Idunno 01/17/18 02:55:28 PM
#10783   Continued roller coaster with closing at $7.49 on orangecat 01/17/18 01:30:24 PM
#10782   Hard to say my friend. I Kid-A 01/17/18 01:01:35 PM
#10781   Anyone care to predict the trading range next Good Sport 01/17/18 12:18:06 PM
#10780   Andy this case of week illustrates how effective Burnttoast247 01/17/18 12:14:19 PM
#10779   https://literature.cytosorb-therapy.com/infoitem/first-application-cvvhdf-plasma andy55q 01/17/18 09:21:04 AM
#10778   New Great Case Report.4 year old girl with berthabluefish1 01/17/18 08:06:56 AM
#10777   Cart T cell therapy News heating up berthabluefish1 01/16/18 08:47:44 PM
#10776   Thank you Andy!! Canes16 01/16/18 12:26:40 PM
#10775   I did andy55q 01/16/18 12:23:49 PM
#10774   This is great news! Has anyone sent Canes16 01/16/18 12:19:58 PM
#10773   FDA launches accelerated review program for products needed dah174174 01/16/18 11:19:34 AM
#10772   So I was listening to some music videos orangecat 01/16/18 10:36:19 AM
#10771   And this: Emergency Use Authorization (EUA) An Emergency Use Idunno 01/15/18 11:42:33 AM
#10770   From Wiki: An emergency use authorization (EUA), in Idunno 01/15/18 11:35:26 AM
#10769   cytosorb-therapy.com/wp-content/uploads/2018/01/CytoSorb_Users_Meeting_Brus Aliberto 01/15/18 11:14:32 AM
#10768   What is EUA? TIA Canes16 01/15/18 11:12:21 AM
#10767   The Liver Disease Treatment Market in Europe alone berthabluefish1 01/15/18 11:11:07 AM
#10766   Im probably reading / hoping way too much Idunno 01/15/18 11:01:18 AM
#10765   Chan used the word “Catalysts”. I suppose that Idunno 01/15/18 10:55:57 AM
#10764   exactly. was told to expect a case report Psuforlife 01/15/18 10:50:19 AM
#10763   Thanks Psuforlife.That would be 2 great indications for berthabluefish1 01/15/18 10:35:28 AM
#10762   Bertha - probably looking at live failure Psuforlife 01/15/18 09:37:37 AM
#10761   The Quote you are referring to: “Meanwhile, we Idunno 01/14/18 09:22:21 PM
#10760   Any thoughts on what the New High Volume berthabluefish1 01/14/18 08:59:55 PM
#10759   It would be something to see EUA! Where Idunno 01/14/18 05:33:37 PM
#10758   Perfect post. I hope the good Doctor is Idunno 01/13/18 07:19:22 PM
#10757   Flu epidemic spreading across US techxen 01/13/18 06:50:31 PM
#10756   IF CTSO CAN HOLD RECENT GAINS AND BREAK Burnttoast247 01/13/18 09:08:52 AM
#10755   That's Somebody's daughter who died ! Good Sport 01/12/18 09:06:16 PM
#10754   Should have been approved, would have helped ! Good Sport 01/12/18 09:05:23 PM
#10753   Could be the reason for the uptick in techxen 01/12/18 05:38:49 PM
PostSubject