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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: Current Report Filing (8-k) 08/09/2017 06:06:53 AM
CTSO News: Quarterly Report (10-q) 08/07/2017 04:14:03 PM
CTSO News: Frost & Sullivan Lauds CytoSorbents for Leading the Critical Care Immunotherapy Segment with its Novel Blood Purification Sol... 08/02/2017 07:00:00 AM
CTSO News: Current Report Filing (8-k) 07/06/2017 05:22:56 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 06/13/2017 06:20:02 PM
PostSubject
#9867   I work in a hospital.... HadToHavit 09/20/17 10:21:57 PM
#9866   The AMA ala allopathic medicine here in the Good Sport 09/20/17 09:41:50 PM
#9865   How would you like to hear HadToHavit 09/20/17 09:32:52 PM
#9863   Cytosorb Registry now at 153 centers...up from 147 centers. Canes16 09/20/17 12:47:46 PM
#9861   Chan mentioned this? Chan has mentioned a pearsby09 09/20/17 12:32:19 PM
#9860   Plus 49% of patients from the Novartis Cart berthabluefish1 09/20/17 10:36:55 AM
#9859   But nobody knows exactly how the Trump administration Good Sport 09/20/17 10:33:19 AM
#9858   I will step in. The EU granted pearsby09 09/20/17 08:01:10 AM
#9857   Well at least I got someone's best guess. HadToHavit 09/19/17 10:48:25 PM
#9856   Enough with the FDA, they are 3-4 years coldterdinvestor 09/19/17 06:01:02 PM
#9855   Wonderful Andy! HadToHavit 09/19/17 05:18:51 PM
#9854   Andy, thanks for posting these cases of the newguy49 09/19/17 05:14:31 PM
#9853   Case of the week 37/2017 andy55q 09/19/17 04:40:16 PM
#9852   jgr - are you talking about the IR Psuforlife 09/19/17 01:46:47 PM
#9851   Where the ---- is the PR firm Chan J G R 09/19/17 01:32:53 PM
#9850   FDA ? HadToHavit 09/19/17 12:46:23 PM
#9849   I was going to qualify with that possibility. pearsby09 09/18/17 05:06:15 PM
#9848   BTW. Water intoxication is a real thing. orangecat 09/18/17 12:27:06 PM
#9847   Is their ANY downside to using this filter? pearsby09 09/18/17 12:15:22 PM
#9846   30th ESICM Annual Congress 2017 andy55q 09/18/17 11:05:53 AM
#9845   22 cents pre split. HadToHavit 09/18/17 09:54:05 AM
#9844   Two Thumbs up ! Thanks for answering my Good Sport 09/16/17 10:39:57 AM
#9843   Very informative tech! Strengthens my question... HadToHavit 09/16/17 07:36:22 AM
#9842   Read the transcript from the last CC techxen 09/15/17 08:03:55 PM
#9841   So... how does someone... or some group HadToHavit 09/15/17 04:08:47 PM
#9840   last minute trades, 70'000 shares (97'000 to 167'000), caesare74 09/15/17 04:03:19 PM
#9839   Fully agree, Good Sport. Daytrader jump in/out following caesare74 09/15/17 02:22:11 PM
#9838   Any impact for cytosorbents from the March 2017 Good Sport 09/15/17 02:15:56 PM
#9837   Another Friday..... what will it bring? HadToHavit 09/15/17 08:56:06 AM
#9836   In the springtime, cash was raised by selling ping_pow_princess 09/15/17 01:14:37 AM
#9835   Most people will sell on news to lock ping_pow_princess 09/14/17 11:29:35 PM
#9834   Not to worry, ole chanie still made his coldterdinvestor 09/14/17 05:27:05 PM
#9833   Normal day trading, they bought in the 4's Good Sport 09/14/17 04:07:24 PM
#9832   I'm guessing this is notmal profit taking and Good Sport 09/14/17 04:03:41 PM
#9831   AMED... not a good example... HadToHavit 09/14/17 03:44:18 PM
#9830   The us govt has 20 million dollars already Good Sport 09/14/17 03:16:58 PM
#9829   AEMD is smaller than we are and they SABAI 09/14/17 02:33:08 PM
#9828   Now there is a great question that all HadToHavit 09/14/17 02:29:50 PM
#9827   I'd like to know what the hell Good Sport 09/14/17 01:46:22 PM
#9826   Not only go below $5, may get low 4s. slappie 09/14/17 01:29:42 PM
#9825   3.5 months left in 2017, only thing now Good Sport 09/14/17 12:58:19 PM
#9824   Waiting for a good entry point to add Good Sport 09/14/17 12:52:45 PM
#9823   Both the 50 and the 200 day moving Good Sport 09/14/17 12:49:34 PM
#9822   Anyone think it will go back down below Good Sport 09/14/17 12:40:35 PM
#9821   It's not good news. It's fluff. All imo. SABAI 09/14/17 12:26:49 PM
#9820   Down 6%...... really Ping? HadToHavit 09/14/17 12:20:55 PM
#9819   MONMOUTH JUNCTION, N.J., Sept. 14, 2017 /PRNewswire/ -- andy55q 09/14/17 08:44:46 AM
#9818   Or maybe we need some FDA approvals! Good Sport 09/14/17 12:11:26 AM
#9817   I'd like to see a partnership with Baxter Tim501 09/13/17 07:33:04 PM
#9816   Pears, actually I agree with you, cost notwithstanding. cars100cars 09/13/17 09:11:17 AM
PostSubject