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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) 11/13/2017 06:04:58 AM
CTSO News: Quarterly Report (10-q) 11/09/2017 04:23:23 PM
CTSO News: Securities Registration: Employee Benefit Plan (s-8) 09/26/2017 06:04:46 AM
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
PostSubject
#10354   caesare74 do you think we will hear anything berthabluefish1 11/19/17 08:58:45 AM
#10353   thank you from my side too, techxen! Great caesare74 11/19/17 05:33:06 AM
#10352   Andy, Murph1953 11/17/17 05:32:59 PM
#10350   techxen, thank you for your work on military biotech48 11/17/17 03:03:57 PM
#10349   The problem is that the whole bio sector eskay1954 11/17/17 12:58:53 PM
#10348   H.R. 2810: National Defense Authorization Act techxen 11/17/17 09:58:09 AM
#10347   At least you used the word "Applications" rather pearsby09 11/16/17 03:07:22 PM
#10346   Sure breed and beads....LOL... SABAI 11/16/17 02:57:58 PM
#10345   Has everyone forgotten about the Agora Financial story? andy55q 11/16/17 09:51:36 AM
#10344   The German newsletter that recently recommended CTSO said dah174174 11/16/17 09:27:36 AM
#10343   Remember the Agora Financial Article.A poster just posted berthabluefish1 11/16/17 08:59:24 AM
#10342   Who did you talk to? If it ping_pow_princess 11/15/17 09:55:12 PM
#10341   2-3 years... I doubt that. This is another orangecat 11/15/17 09:28:48 PM
#10340   Another use for Cytosorbents future filters ??? Good Sport 11/15/17 08:25:35 PM
#10339   well i did ask the company and they Psuforlife 11/15/17 03:48:19 PM
#10338   Are they putting a floor in so the Canes16 11/15/17 03:43:12 PM
#10337   So what's everyone's thoughts on this large bid Psuforlife 11/15/17 03:06:40 PM
#10336   ping, I agree with the timing of the Canes16 11/15/17 09:33:52 AM
#10335   I do not know if they are selling ping_pow_princess 11/14/17 06:13:57 PM
#10334   Ping, Could it be that Dr. Chan is raptorjockey 11/14/17 05:47:48 PM
#10333   Vincent didn't say whether this is per quarter ping_pow_princess 11/14/17 04:37:17 PM
#10332   it's because they make money shorting plain and Good Sport 11/14/17 04:05:03 PM
#10331   A jump in volume at about 15:27-15:30 PM, ping_pow_princess 11/14/17 03:54:41 PM
#10328   You would be hard pressed to find any orangecat 11/14/17 02:42:02 PM
#10325   Anyone can say anything they want anonymously on orangecat 11/14/17 09:54:04 AM
#10323   Is this $35 million phase production the number Good Sport 11/14/17 04:08:08 AM
#10322   Oooops. Convergent Dental is the one that's privately Murph1953 11/13/17 11:54:42 PM
#10321   Deloitte Fast 500. I looked at the medical Murph1953 11/13/17 11:31:32 PM
#10320   I am going with Dr. Chan's estimated 2020 biotech48 11/13/17 10:44:36 PM
#10319   • 300-500 patient, 20-25 center randomized, controlled PMA pearsby09 11/13/17 10:18:34 PM
#10318   This is from their October presentation regarding the ping_pow_princess 11/13/17 08:01:39 PM
#10317   Can produce up to $35 million in sales ping_pow_princess 11/13/17 07:55:59 PM
#10316   How many filters will the new production facility Good Sport 11/13/17 05:22:11 PM
#10315   Today's Aggressive Anti Cancer Therapy Wouldn't Exist Today berthabluefish1 11/13/17 10:26:47 AM
#10314   This is from the last shareholder letter, "The ping_pow_princess 11/13/17 12:06:25 AM
#10313   Chan needs a large scale trial for ANY pearsby09 11/12/17 01:22:51 PM
#10312   Dr. Chan said we envisioned that Cytosorb would berthabluefish1 11/12/17 09:13:28 AM
#10310   On Nov 9, CTSO reported that they sold ping_pow_princess 11/12/17 12:05:38 AM
#10307   R2 will be very very late! That pearsby09 11/11/17 02:48:42 PM
#10306   Does anyone have an idea/guess about when REFRESH Murph1953 11/11/17 12:29:39 PM
#10305   CTSO has provided opportunities to make a profit ping_pow_princess 11/10/17 11:16:40 PM
#10304   I'm reading the back and forth of biotech htcblue 11/10/17 07:11:47 PM
#10303   Dr. Chan has said PLENTY over the last pearsby09 11/10/17 05:55:05 PM
#10302   enough is enough! How are you going to biotech48 11/10/17 05:46:46 PM
#10301   CTSO shows no sign of slowing expansion of pearsby09 11/10/17 05:30:17 PM
#10300   If there were personal contacts, they wouldn't be raptorjockey 11/10/17 05:11:55 PM
#10298   Right pearsby, that is why I said they Canes16 11/10/17 04:33:18 PM
#10297   As far as people knowing contacts, so far pearsby09 11/10/17 04:22:11 PM
#10296   Thanks andy. I think it puts things Canes16 11/10/17 03:57:45 PM
#10294   psuforlife...one of the posters on this board. Canes16 11/10/17 03:44:20 PM
PostSubject