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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: Dr. Carl H. June, Cancer Immunotherapy Pioneer, Joins CytoSorbents Scientific Advisory Board 03/22/2017 07:15:00 AM
CTSO News: CytoSorb® Treatment of HLH - The Parallel to Cytokine Release Syndrome in Cancer Immunotherapy 03/20/2017 07:30:00 AM
CTSO News: CytoSorbents Announces CytoSorb® Partnership with Dr. Reddy's Laboratories 03/16/2017 07:00:00 AM
CTSO News: Current Report Filing (8-k) 03/09/2017 05:02:17 PM
CTSO News: CytoSorbents Highlights Activities at the 22nd International Conference on Advances in Critical Care Nephrology 03/07/2017 08:00:00 AM
PostSubject
#8362   How bout a nice Hawawiian Punch? Loaded with kfcyahoo 03/24/17 06:43:24 PM
#8361   "De-risked" is the newest term that has been orangecat 03/24/17 04:16:33 PM
#8360   Anyone have more info on this sepsis / Astavakra 03/23/17 01:12:27 PM
#8359   Great Older Article.Last Girl's Hope,Altered Immune Cells Beat berthabluefish1 03/23/17 11:35:52 AM
#8358   More than 400 people attended our yesterdays lunch andy55q 03/23/17 08:12:15 AM
#8357   Case of the week 11/2017 andy55q 03/23/17 08:10:48 AM
#8356   Some New Photos on Facebook. berthabluefish1 03/22/17 03:39:16 PM
#8355   Clearly stock price does not reflect what the Rockobongo1281 03/22/17 12:33:52 PM
#8354   Couldn't tell by the case report the final jlo46383 03/22/17 12:33:37 PM
#8353   A total of 9 treatments with CytoSorb over Aliberto 03/22/17 12:08:40 PM
#8352   New Case Report Today.Looks like that used Cytosorb berthabluefish1 03/22/17 11:22:01 AM
#8351   Thanks Psuforlife.Good to see ya back.Man things are berthabluefish1 03/22/17 09:42:58 AM
#8350   was told and shown a picture of over Psuforlife 03/22/17 09:28:06 AM
#8349   Dr. Carl H. June, Cancer Immunotherapy Pioneer, Joins dah174174 03/22/17 08:50:55 AM
#8348   The addition of Dr. Carl June to the Gman214 03/22/17 08:30:42 AM
#8347   I just read an article saying that Tolcilzumba berthabluefish1 03/20/17 10:11:59 PM
#8345   Berta: interesting that you are mentioning Roche. I caesare74 03/20/17 02:23:55 PM
#8344   Roche is listed as a Potential Partner for berthabluefish1 03/20/17 11:06:58 AM
#8343   The Last Paragraph in todays Press Release Very berthabluefish1 03/20/17 10:23:35 AM
#8342   NEWS -- CytoSorb® Treatment of HLH - The Paulness 03/20/17 08:28:06 AM
#8341   CytoSorb(R) Treatment of HLH - The Parallel to dah174174 03/20/17 07:56:01 AM
#8340   New Publications andy55q 03/16/17 07:52:41 PM
#8339   Interesting that Dr. Reddy is into devices. Jacquescode 03/16/17 03:55:13 PM
#8337   Agree, I value and look forward to Bertha's Gman214 03/16/17 01:15:22 PM
#8334   Users Meeting Next Week South Africa Participants 5! berthabluefish1 03/16/17 12:29:59 PM
#8333   We Need some large trials..so tired of case pearsby09 03/16/17 12:18:33 PM
#8332   New Partner is on the NYSE Tick.RDY Looks berthabluefish1 03/16/17 10:30:45 AM
#8331   NEWS -- CytoSorbents Announces CytoSorb® Partnership with Dr. Paulness 03/16/17 08:27:14 AM
#8330   India has been a bust. 1 attending the cytosorbusermeeting2017. clints 03/16/17 01:16:28 AM
#8329   Thanks, all this great news and we sit clints 03/15/17 11:45:57 PM
#8328   It is obvious that CytoSorbents are no longer Aliberto 03/15/17 10:30:10 AM
#8326   Case of the week 10/2017 andy55q 03/15/17 08:46:01 AM
#8325   Great New Case Report From Russia. berthabluefish1 03/15/17 04:56:12 AM
#8324   Thanks stingman49. berthabluefish1 03/14/17 03:59:06 PM
#8323   .From Dr. Chan: In terms of the stingman49 03/14/17 03:48:45 PM
#8322   Biogen 2000 revenues $926M, OS 71M shares Murph1953 03/13/17 06:48:19 PM
#8321   I have sent a email to Dr. Chan stingman49 03/13/17 04:10:25 PM
#8320   standard of care kjpcrna 03/13/17 02:45:55 PM
#8319   Take a look at AEMD News today.Also interesting berthabluefish1 03/13/17 01:25:31 PM
#8318   It may be developed by a special society berthabluefish1 03/13/17 01:04:40 PM
#8317   Bertha - is SOC an official designation or Rockobongo1281 03/13/17 12:34:03 PM
#8315   JMO Why they say expect to achieve operating berthabluefish1 03/13/17 12:31:12 PM
#8314   Hard to find much about Sepsis in China.Found berthabluefish1 03/11/17 03:36:03 PM
#8313   Thank you, Bertha. Who knows why DC Rockobongo1281 03/11/17 02:39:43 PM
#8312   thank you Rockobongo1281 03/11/17 02:37:35 PM
#8311   There are more post about this on yahoo berthabluefish1 03/11/17 12:11:58 PM
#8310   Sounds interesting. The material is just at the orangecat 03/11/17 12:06:49 PM
#8309   Competition? Better product? Rockobongo1281 03/11/17 11:21:47 AM
#8308   New head of FDA, Dr. Gottlieb Murph1953 03/10/17 06:40:08 PM
#8305   The 100M is just 10 percent of total orangecat 03/10/17 09:15:29 AM
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