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Cytosorbents Corporation (CTSO)

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Last Post: 12/15/2017 1:46:20 PM - Followers: 187 - Board type: Free - Posts Today: 3

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: Statement of Changes in Beneficial Ownership (4) 12/08/2017 04:13:55 PM
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
PostSubject
#10546   Bossman says it's time to load at sub pearsby09 12/15/17 01:46:20 PM
#10543   My thoughts are this. Any cash raising will ping_pow_princess 12/14/17 11:30:05 PM
#10541   That # would be good for total revenue, clints 12/14/17 09:56:06 PM
#10540   "The blood purification cartridge can be used with Good Sport 12/14/17 08:17:36 PM
#10538   snow - the bottom line is actual this. Psuforlife 12/14/17 03:54:36 PM
#10537   That is NOT exactly what he said. Rockobongo1281 12/14/17 03:54:34 PM
#10536   Dr. Chan has repeated many times that the biotech48 12/14/17 03:50:00 PM
#10535   mikes It is the bottom line that should snow 12/14/17 03:41:12 PM
#10534   Looks like 5.65 is the bottom resistance. pearsby09 12/14/17 03:31:04 PM
#10533   Obviously, all these anecdotal references are NOT convincing pearsby09 12/14/17 03:07:28 PM
#10532   orange- my contact in india have said Psuforlife 12/14/17 01:22:58 PM
#10531   Homer Simpson terms please ? Good Sport 12/14/17 12:38:10 PM
#10530   Might find this interesting also.Role of Interleukin 6 berthabluefish1 12/14/17 11:17:22 AM
#10529   It sounds like researchers have determined that elevated orangecat 12/14/17 11:08:12 AM
#10528   Does CAR T Cell therapy use chemo or Good Sport 12/13/17 05:39:08 PM
#10526   Newswise — BOSTON – Cancer therapies including radiation andy55q 12/13/17 04:30:04 PM
#10524   This will be rotating around a 6 dollars pearsby09 12/13/17 03:31:16 PM
#10523   Confirmation bias is a bit*h... badgercat 12/13/17 03:30:20 PM
#10522   It’s a $6 stock and will be a HadToHavit 12/13/17 03:26:44 PM
#10520   We are below $ 6.........how can they get mikesmith999945 12/13/17 02:31:08 PM
#10517   Article From Newswise.Double -Edged Sword:Killing Cancers Cells Can berthabluefish1 12/13/17 11:37:41 AM
#10516   Yea we should be in the $20's now Good Sport 12/13/17 11:07:44 AM
#10515   This stock is so easily manipulated with the orangecat 12/13/17 10:06:05 AM
#10514   When the company is selling ATM on great clints 12/13/17 10:02:41 AM
#10513   Thanks for the update Psuforlife. berthabluefish1 12/13/17 09:55:27 AM
#10512   when blood is in the water it doesn't Psuforlife 12/13/17 09:52:02 AM
#10511   Anyone know what the hell is going on Rockobongo1281 12/13/17 09:40:10 AM
#10510   IDE application update overdue. I think news ping_pow_princess 12/13/17 09:03:18 AM
#10509   Using some paint.... DebitsAndCredits 12/12/17 08:43:16 PM
#10508   That's fine if you want to wait ANOTHER pearsby09 12/12/17 05:55:12 PM
#10507   paulsby, what you are posting is just not biotech48 12/12/17 05:37:01 PM
#10506   6.28 pps and declining. The only way pearsby09 12/12/17 04:56:15 PM
#10505   Obviously, we are witnessing the ramifications of insider pearsby09 12/12/17 02:21:04 PM
#10504   make sure your online account is not lending Good Sport 12/12/17 12:22:15 PM
#10503   New York Slime day traders are manipulating it Good Sport 12/12/17 12:20:02 PM
#10502   Investor Relations should be able to answer these Good Sport 12/12/17 12:18:18 PM
#10501   This is the same trading action when CTSO clints 12/11/17 09:42:58 PM
#10500   "It is a wonder that it hasn't been pearsby09 12/11/17 07:28:48 PM
#10499   No, we do not all agree that the biotech48 12/11/17 07:22:38 PM
#10498   The trial is robust with large "N", multi pearsby09 12/11/17 05:46:12 PM
#10497   Rockobongo, Is it possible that the decision to raptorjockey 12/11/17 05:15:58 PM
#10496   Just curios vinovista 12/11/17 04:55:43 PM
#10495   Apparently todays news in not consider material news vinovista 12/11/17 04:55:15 PM
#10494   Not how that works. It's misleading, b/c Rockobongo1281 12/11/17 04:49:22 PM
#10493   may have gotten a waiver for the transaction, Good Sport 12/11/17 04:43:59 PM
#10492   Sorry, but wrong. Employees are granted shares Rockobongo1281 12/11/17 04:26:55 PM
#10491   Employees are granted options to purchase company shares Good Sport 12/11/17 04:20:35 PM
#10490   Only under Rule 10b5-1. CFO was not Rockobongo1281 12/11/17 04:01:41 PM
#10489   except pre-authorized stock option sales setup by HR Good Sport 12/11/17 03:59:38 PM
#10488   What's the relevancy of your question? Rockobongo1281 12/11/17 03:36:49 PM
PostSubject