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Cytosorbents Corporation (CTSO)

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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: CytoSorbents to Report Fiscal 2016 Operating and Financial Results 07:00 AM
CTSO News: CytoSorbents to Present at the 19th Annual BIO CEO & Investor Conference 02/07/2017 08:00:00 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 02/01/2017 03:56:42 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 02/01/2017 03:56:15 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 02/01/2017 03:54:03 PM
News News Alert: CytoSorbents to Report Fiscal 2016 Operating and Financial Results 02/24/2017 07:00:00 AM
PostSubject
#8234   Looks like the FDA is taking notice of berthabluefish1 02/24/17 10:51:59 AM
#8233   I believe it is also almost two full orangecat 02/24/17 10:44:36 AM
#8232   They usually do this after the market closes. berthabluefish1 02/24/17 09:38:48 AM
#8231   NEWS -- CytoSorbents to Report Fiscal 2016 Operating Paulness 02/24/17 08:25:51 AM
#8230   Immunexpress wins FDA clearance for sepsis tests that Gman214 02/23/17 05:46:23 PM
#8229   New On PubMed Feb..Perioperative Hemoglobin are under berthabluefish1 02/23/17 09:45:53 AM
#8228   Yes. But I didn't think CTSO really Rockobongo1281 02/21/17 01:52:16 PM
#8227   I received the email. A new PR initiative dah174174 02/21/17 01:51:32 PM
#8226   Anyone receive CTSO email this morning about new Rockobongo1281 02/21/17 09:15:00 AM
#8225   Interesting Program Cytosorb in Heart Transplantation and also berthabluefish1 02/20/17 10:07:47 PM
#8224   International CytoSorb Users’ meeting andy55q 02/20/17 08:17:20 PM
#8223   was the 3 new from Croatia? are Psuforlife 02/20/17 02:26:56 PM
#8222   Got mixed up.There are 131 centers on the berthabluefish1 02/20/17 12:01:44 PM
#8221   bertha - i don't see south Africa on Psuforlife 02/20/17 11:46:02 AM
#8220   Cytosorb Registry 131 Centers Now .Looks like South berthabluefish1 02/20/17 11:26:50 AM
#8219   University of Rostock Symposium. techxen 02/18/17 11:30:59 AM
#8218   Good post by CG on the yahoo board berthabluefish1 02/15/17 03:36:50 PM
#8217   A new case of the week has been orangecat 02/15/17 01:12:51 PM
#8216   Thanks again Jacquescode.Maybe he left some news out berthabluefish1 02/14/17 08:53:07 PM
#8215   Hi Bertha. I tuned into the presentation Jacquescode 02/14/17 07:49:10 PM
#8214   Thanks Rock. berthabluefish1 02/14/17 06:58:49 PM
#8213   Not much news. Operating profitability within 2 Rockobongo1281 02/14/17 05:06:09 PM
#8212   Anyone listen to the presentation today?Just got home. berthabluefish1 02/14/17 04:00:34 PM
#8211   Berthabluefish, thanks for pointing out the AKI dp60 02/14/17 09:25:05 AM
#8210   Acute Kidney Injury is becoming a huge problem berthabluefish1 02/13/17 06:37:41 PM
#8209   Incentive Stock Options orangecat 02/13/17 03:07:10 PM
#8208   So is the AKI associated with cytokine release? vinovista 02/13/17 02:31:50 PM
#8207   Acute Kidney Injury IL-6 02/13/17 01:43:04 PM
#8206   What does AKI stand for? vinovista 02/13/17 12:12:58 PM
#8205   Recent 300 Patient Study AKI following Cardiac Surgery.AKI berthabluefish1 02/11/17 10:25:40 AM
#8204   Cars, we have been in the CASE STUDY pearsby09 02/10/17 01:14:06 PM
#8203   What's clear is the "beads" performed for this cars100cars 02/10/17 09:30:55 AM
#8202   Maybe they do? firefighter2830 02/09/17 08:02:54 PM
#8201   Clearly you do not know all the pitfalls pearsby09 02/09/17 05:41:34 PM
#8200   clearly you don't understand that it was a Rockobongo1281 02/09/17 05:29:03 PM
#8198   I have said all along..these beads are not pearsby09 02/09/17 12:06:57 PM
#8197   Wow..the flow rate through the Beads at 30%...something pearsby09 02/09/17 11:52:50 AM
#8196   Case of the week 05/2017 andy55q 02/09/17 08:53:02 AM
#8195   Thanks life. You are a highly respected Jacquescode 02/08/17 01:52:09 PM
#8192   Moreover, with back to back conferences on Feb Jacquescode 02/08/17 01:04:15 PM
#8191   with back to back investor conferences on next Psuforlife 02/08/17 10:27:24 AM
#8190   To be clear pearsby, you own no shares biotech48 02/07/17 05:22:40 PM
#8189   Where is everybody? This has become the pearsby09 02/07/17 04:52:25 PM
#8188   Make sure you put in for more than kjpcrna 02/07/17 01:21:32 PM
#8187   NEWS -- CytoSorbents to Present at the 19th Paulness 02/07/17 09:10:45 AM
#8186   Putting a couple trades in at 5.11 and pearsby09 02/06/17 02:12:48 PM
#8185   Under Cytosorb events it lists Maxim health meeting jlo46383 02/04/17 06:27:21 PM
#8184   8 years ago I thought Like you..Now..after an pearsby09 02/04/17 02:53:41 PM
#8183   Deep inside you know this will go nuts SABAI 02/03/17 04:05:35 PM
#8182   Fair point. Although I don't think Dr. Rockobongo1281 02/03/17 04:04:38 PM
PostSubject