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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 Selected to Present at Special Operations SOMSA 2017 Conference and 18th Annual B. Riley & Co. Investor Conferen... 05/24/2017 08:05:00 AM
CTSO News: Aferetica and CytoSorbents Extend Exclusive "Life-saving" Partnership through 2021 05/22/2017 09:00:00 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 05/16/2017 06:01:40 PM
CTSO News: Current Report Filing (8-k) 05/12/2017 05:08:33 PM
CTSO News: CytoSorbents Reports First Quarter 2017 Financial Results 05/08/2017 04:30:00 PM
PostSubject
#8922   Continuous hemoadsorption with a cytokine adsorber during sepsis techxen 05/27/17 04:59:22 PM
#8921   Yes, this has been a Milking Machine for pearsby09 05/27/17 11:56:18 AM
#8920   Great research Techxen. I find this to Jacquescode 05/26/17 09:28:12 PM
#8919   WHA Adopts Resolution on Sepsis techxen 05/26/17 06:50:47 PM
#8918   Probably a good reason why studies and real coldterdinvestor 05/26/17 01:46:29 PM
#8917   Anyone care to guess who's on the Compensation kjpcrna 05/26/17 01:21:06 PM
#8916   Here's a summary of 2016 total compensation: Chan kjpcrna 05/26/17 12:32:48 PM
#8915   And don't forget to vote AGAINST chanie and coldterdinvestor 05/26/17 12:04:13 PM
#8914   Vote if you own shares by June 5th. kjpcrna 05/26/17 10:21:43 AM
#8913   If you think Eradicating Sepsis world wide is pearsby09 05/25/17 07:45:42 PM
#8912   Cytosorb worked for HLH where Tocilizumab did not.They berthabluefish1 05/25/17 05:31:42 PM
#8911   Keep in mind that not all posters on Jacquescode 05/25/17 05:22:52 PM
#8910   If we were truly eradicating Sepsis, the SP coldterdinvestor 05/25/17 05:04:05 PM
#8909   paulsby, please explain why you would pass up biotech48 05/25/17 04:18:38 PM
#8908   Pears, Have been watching you keep it real ml24 05/25/17 04:08:58 PM
#8907   Please Bertha, One step at a time. pearsby09 05/25/17 12:24:20 PM
#8906   thank you for your response, I believe that biotech48 05/24/17 05:09:35 PM
#8905   The answer might depend on the country and cars100cars 05/24/17 03:46:44 PM
#8903   psuforlife, a question. Since we are not FDA biotech48 05/24/17 02:34:45 PM
#8902   They always seem to hook up Cytosorb with berthabluefish1 05/24/17 01:09:37 PM
#8901   IMO Something that might come out of the berthabluefish1 05/24/17 11:12:09 AM
#8900   would nice to see an order from the Psuforlife 05/24/17 09:37:27 AM
#8899   Thanks Andy55q, dp60 05/24/17 08:59:03 AM
#8898   NEWS -- CytoSorbents Selected to Present at Special Paulness 05/24/17 08:55:08 AM
#8897   Case of the week 20/2017 andy55q 05/24/17 06:46:49 AM
#8896   I remember when the price was .09. On vinovista 05/23/17 08:58:03 PM
#8895   "Not sure, but have begun to believe that pearsby09 05/23/17 08:15:44 PM
#8894   I pretty much used the hi's and low's kfcyahoo 05/23/17 05:38:40 PM
#8893   So you have no problem with chanie sticking coldterdinvestor 05/23/17 05:29:17 PM
#8892   Well you can use $15.00+ as your reference vinovista 05/23/17 05:02:37 PM
#8890   kfcyahoo, exactly right. All CTSO financials improving steadily. cars100cars 05/23/17 09:25:56 AM
#8889   Definetly not content with the sp- down ~74% kfcyahoo 05/22/17 03:48:18 PM
#8887   The lack of Data will keep this stock pearsby09 05/22/17 02:55:39 PM
#8886   Just another FLUFF PR, only difference is some coldterdinvestor 05/22/17 01:19:33 PM
#8885   This company will not survive with Chan in slappie 05/22/17 12:49:26 PM
#8884   No more good news please HadToHavit 05/22/17 11:34:01 AM
#8883   The PPS is not reflecting your optimism. Perhaps pearsby09 05/22/17 11:27:28 AM
#8882   Italy has been one of our best countries. Psuforlife 05/22/17 10:14:02 AM
#8881   $10 million contract news with just 2 weeks cars100cars 05/22/17 10:08:08 AM
#8880   Wow over 300 people attended the Conf. in berthabluefish1 05/22/17 09:16:57 AM
#8879   NEWS -- Aferetica and CytoSorbents Extend Exclusive "Life-saving" Paulness 05/22/17 09:10:54 AM
#8878   Hope some of them have some sales skills, coldterdinvestor 05/22/17 09:02:58 AM
#8876   CTSO Full Time Employees Now 70 Yahoo berthabluefish1 05/21/17 09:53:07 PM
#8873   This is the biggest Endocarditis Case Series to berthabluefish1 05/21/17 01:59:13 PM
#8872   Great finds bluefish. More confirmations of the Jacquescode 05/21/17 11:10:41 AM
#8871   Wow..get a PR. This company has only pearsby09 05/21/17 10:44:51 AM
#8870   I think we could get a PR. for berthabluefish1 05/20/17 12:10:06 PM
#8869   Yes... great articles. I wish the PR HadToHavit 05/20/17 12:05:31 PM
#8868   Thanks Andy.Can you put them on the yahoo board?Bert berthabluefish1 05/20/17 10:30:38 AM
#8867   "Andy", thank you for always posting the "articles". tired1 05/20/17 10:22:20 AM
PostSubject