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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 Launches VetResQ™ for U.S. Veterinary Market 01/20/2017 09:00:00 AM
CTSO News: Fresenius Medical Care and CytoSorbents Expand Original Partnership and Add New Co-Marketing Agreement for Worldwide CytoSorb... 01/11/2017 02:00:00 AM
CTSO News: Current Report Filing (8-k) 01/10/2017 04:53:11 PM
CTSO News: Current Report Filing (8-k) 01/10/2017 03:29:52 PM
CTSO News: CytoSorbents Pre-announces Q4 2016 and Full-Year 2016 Results 01/10/2017 09:00:00 AM
News News Alert: CytoSorbents Launches VetResQ™ for U.S. Veterinary Market 01/20/2017 09:00:00 AM
PostSubject
#8098   My friend that works for a vet hospital Psuforlife 01/20/17 04:53:51 PM
#8097   Anything government related moves slow. Check out the orangecat 01/20/17 04:28:16 PM
#8096   We have a new one: Real World Evidence longtrailer 01/20/17 03:53:16 PM
#8095   Well we do have FADASIA, AA, the Cure pearsby09 01/20/17 03:16:11 PM
#8094   I don't think the FDA is that uncaring longtrailer 01/20/17 03:10:39 PM
#8093   What better trial and error experiment....Rover and Kitty...Better pearsby09 01/20/17 03:03:40 PM
#8092   Just a shame that animals in the US longtrailer 01/20/17 02:43:48 PM
#8091   Cartridge would only be used in relatively infrequent kjpcrna 01/20/17 12:40:52 PM
#8090   In-line with industry trends away from ma and dp60 01/20/17 11:39:59 AM
#8089   Feedback from my neighbor: Very rare. There are lots orangecat 01/20/17 11:03:20 AM
#8088   $14 billion spent in the U.S. for Veterinary berthabluefish1 01/20/17 10:57:31 AM
#8087   I have a neighbor and an uncle who orangecat 01/20/17 10:18:30 AM
#8086   VetResQ is manufactured and AVAILABLE for veterinary use Canes16 01/20/17 10:15:40 AM
#8084   Looks like this New Product is Ready To Go! berthabluefish1 01/20/17 09:59:00 AM
#8082   dah - not sure how big this market Psuforlife 01/20/17 09:55:44 AM
#8080   NEWS -- CytoSorbents Launches VetResQ™ for U.S. Veterinary Market Paulness 01/20/17 09:41:09 AM
#8079   CytoSorbents Launches VetResQ(TM) for U.S. Veterinary Market dah174174 01/20/17 09:37:07 AM
#8077   Maquet would be a good one Psuforlife.We would berthabluefish1 01/19/17 11:35:21 AM
#8076   bertha - imo we might see Maquet step Psuforlife 01/19/17 10:45:56 AM
#8074   There is a lot of news about Sepsis berthabluefish1 01/19/17 10:17:50 AM
#8073   Bertha - what makes you say that? Rockobongo1281 01/19/17 10:08:48 AM
#8072   Looking forward to a total of 150-200. andy55q 01/19/17 10:02:19 AM
#8071   Thanks andy.Nice to see 9 from the Netherlands berthabluefish1 01/19/17 09:43:38 AM
#8070   International CytoSorb Users’ meeting andy55q 01/19/17 09:25:23 AM
#8069   I still think that we have another potential berthabluefish1 01/18/17 10:23:29 PM
#8068   1 cent is pushing it. Psuforlife 01/18/17 06:38:16 PM
#8067   Okay - yes. The patient died - Rockobongo1281 01/18/17 05:53:31 PM
#8064   I don't mean to be Brash, but who pearsby09 01/18/17 04:34:32 PM
#8063   The filter did its intended job. The CytoSorb clints 01/18/17 04:19:41 PM
#8062   Your sorry to point out the most important pearsby09 01/18/17 03:27:01 PM
#8061   Due to cardiopulmonary insufficiency in the context of pearsby09 01/18/17 12:50:47 PM
#8060   NEW; (The Use of a Cytokine Adsorber (CytoSorb) andy55q 01/18/17 12:31:47 PM
#8059   Use of cytokine filters in cardiopulmonary bypass machines andy55q 01/18/17 11:25:09 AM
#8058   Pre-emptive use is key. these guys get it. Psuforlife 01/18/17 10:09:48 AM
#8057   New case of the week posted. Cytosorb treatment orangecat 01/18/17 10:03:20 AM
#8056   I am glad my 5.95 did not fill. pearsby09 01/17/17 02:53:03 PM
#8054   Fresenius just bought out the Largest Private berthabluefish1 01/16/17 06:24:55 PM
#8053   One more thing BTW...What did the Surrogate marker pearsby09 01/16/17 04:24:27 PM
#8052   Why are so many investors infatuated with the pearsby09 01/16/17 04:10:32 PM
#8051   I wonder why the hemoglobin data is taking SABAI 01/16/17 02:46:53 PM
#8050   IMO Cost Data is going to be a berthabluefish1 01/16/17 12:00:24 PM
#8049   http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2017/CTSO-Poised- longtrailer 01/16/17 11:54:33 AM
#8048   Good New Zacks Article A Win-Win-Win.Good points about berthabluefish1 01/16/17 11:28:41 AM
#8047   I gotcha Psuforlife. berthabluefish1 01/15/17 08:55:55 PM
#8046   No Bertha on the total list Andy posted? Psuforlife 01/15/17 04:30:35 PM
#8045   126 Clinics before.It was 122 and jumped to berthabluefish1 01/15/17 03:15:50 PM
#8044   Does anyone know how many clinics was listed Psuforlife 01/15/17 02:01:32 PM
#8043   CytoSorb is CE Mark approved under the Medical andy55q 01/15/17 09:25:53 AM
#8028   More 0-2 years.... SABAI 01/14/17 03:59:14 PM
#8026   BTW..5.95 will be considered a good Buy 3 pearsby09 01/14/17 03:56:03 PM
PostSubject