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Cytosorbents Corporation (CTSO)

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Last Post: 6/27/2017 1:49:27 PM - Followers: 179 - 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) 06/13/2017 06:20:02 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 06/12/2017 06:52:18 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 06/08/2017 06:39:40 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 06/08/2017 06:39:12 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 06/08/2017 06:38:43 PM
PostSubject
#9183   Great article! dah174174 06/27/17 01:49:27 PM
#9182   Good article about Dr. June by Emily berthabluefish1 06/27/17 12:27:11 PM
#9181  Restored The entire Pearsby thing is tired BorisBeckar 06/27/17 12:16:08 AM
#9179   That post was not me, however, I do pearsby09 06/26/17 03:12:38 PM
#9177   BorisBeckar just got served! Amazing post orangecat! I timflos22 06/24/17 10:31:56 PM
#9176   Spectral’s product and Cytosorb XL are very different devices. orangecat 06/24/17 06:43:29 PM
#9173   Good one, Pears! "BorisBeckar" huh? My apologies for cars100cars 06/24/17 08:58:28 AM
#9172   This cars chap is amusing BorisBeckar 06/24/17 12:19:18 AM
#9171   They have a product called "Drugsorb" for that, pearsby09 06/22/17 04:15:40 PM
#9170   Andy, one of the reports was about a stingman49 06/22/17 04:09:57 PM
#9169   Thank you for choosing to participate in our andy55q 06/22/17 09:49:21 AM
#9168   The BEADS were a steal at 3.30....congrats! Your...Beloved...Pearsby pearsby09 06/21/17 05:59:35 PM
#9167   CTSO's stock price is up 25% since we clints 06/21/17 05:50:46 PM
#9166   Copying post from Yahoo message board: Canes16 06/20/17 12:10:28 PM
#9165   Copying post from Yahoo message board: Canes16 06/20/17 12:09:46 PM
#9164   Affected Acute Kidney Injury is an immense financial berthabluefish1 06/20/17 11:25:59 AM
#9163   Should see some more reimbursements from other countries berthabluefish1 06/20/17 11:10:43 AM
#9162   if they did 3.4m in q2 that would Psuforlife 06/19/17 12:38:16 PM
#9161   PSU, your info suggests CTSO will achieve $12+ cars100cars 06/19/17 11:16:40 AM
#9160   Russia should be big next year. we Psuforlife 06/19/17 10:06:24 AM
#9159   KFC, I'm betting Pears knows the filters work. cars100cars 06/19/17 09:29:48 AM
#9158   Cytosorb Registry Clinical Centers 142 Now. berthabluefish1 06/19/17 09:06:51 AM
#9157   Pears, Couple things. kfcyahoo 06/16/17 10:09:38 PM
#9156   Maybe Fresenius should sell a few filters before coldterdinvestor 06/16/17 06:14:28 PM
#9155   I wonder if they will go after AKI berthabluefish1 06/16/17 03:39:45 PM
#9154   BuyMyAsk The implication of your post is that snow 06/16/17 02:58:33 PM
#9153   If you think Trump has time to study pearsby09 06/16/17 12:44:41 PM
#9152   For every PR about success would have to pearsby09 06/16/17 12:40:22 PM
#9151   Is it possible to archive 510k or 513 andy55q 06/16/17 11:11:21 AM
#9148   Chanie is to busy looking for the next coldterdinvestor 06/16/17 09:50:20 AM
#9147   Or, perhaps, Trump could issue an executive order kfcyahoo 06/15/17 10:51:01 PM
#9146   Hopefully, the Yale-educated/Harvard residency(Beth Israel Deaconess) Dr Chan kfcyahoo 06/15/17 05:55:52 PM
#9145   Your are right. Sorry...it's 50%. The conclusion is SABAI 06/15/17 05:52:03 PM
#9144   on May 8th, you posted that Germany brought biotech48 06/15/17 05:48:32 PM
#9143   I don't understand why the case of the stingman49 06/15/17 05:48:15 PM
#9142   The only problem is that Germany does 90% SABAI 06/15/17 05:30:01 PM
#9141   Thanks for the update Psuforlife.Remember Aferetica mentioned some berthabluefish1 06/15/17 03:43:06 PM
#9140   bertha... presentation went very well i'm told. Psuforlife 06/15/17 02:57:09 PM
#9139   As i have stated over the past 7 BuyMyAsk 06/15/17 01:51:58 PM
#9138   HadToHavit These look like good numbers. Even so snow 06/15/17 12:32:57 PM
#9137   Thanks Psuforlife.AKI is a major unmet need without berthabluefish1 06/15/17 12:09:30 PM
#9136   no idea. was told there normally in a Psuforlife 06/15/17 11:51:24 AM
#9135   vinovista 06/15/17 11:39:44 AM
#9134   Blackout period for what reason please? vinovista 06/15/17 11:39:32 AM
#9133   today are presenting at this bertha. Psuforlife 06/15/17 11:35:25 AM
#9132   no more insider purchase this week. in Psuforlife 06/15/17 11:31:28 AM
#9131   Bertha, we can only hope you're right. Here kjpcrna 06/15/17 11:23:49 AM
#9130   Compelling statement: HadToHavit 06/15/17 11:07:34 AM
#9129   "CytoSorb® has been used safely in more than vinovista 06/15/17 11:02:22 AM
#9128   Events 35th Vicenza Course on AKI&CRRT.Both Aferetica and berthabluefish1 06/15/17 10:59:37 AM
PostSubject