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Cytosorbents Corporation (CTSO)

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Last Post: 4/27/2017 1:00:43 PM - Followers: 180 - Board type: Free - Posts Today: 1

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: Additional Proxy Soliciting Materials (definitive) (defa14a) 08:54 AM
CTSO News: Proxy Statement (definitive) (def 14a) 08:52 AM
CTSO News: Current Report Filing (8-k) 04/24/2017 05:09:36 PM
CTSO News: CytoSorbents Awarded $1M Phase II SBIR Contract by U.S. Department of Defense to Advance Fungal Mycotoxin Blood Purification 04/24/2017 08:00:00 AM
CTSO News: CytoSorbents 2017 - Propelling the Company to the "Next Level" 04/19/2017 08:30:00 AM
News News Alert: Additional Proxy Soliciting Materials (definitive) (defa14a) 04/27/2017 08:54:56 AM
PostSubject
#8609   Cardiac Data coming Monday! Info on yahoo board. berthabluefish1 04/27/17 01:00:43 PM
#8608   A good article, also he does not take biotech48 04/26/17 05:43:44 PM
#8607   Need more PR like this!!!! Psuforlife 04/26/17 01:46:32 PM
#8606   Yes the volume has been good ! bustingmyask 04/26/17 01:19:25 PM
#8605   Short interest just over 3%, so a squeeze kjpcrna 04/26/17 01:06:39 PM
#8604   CRRT Market to hit $1.1 billion by 2020.IMO berthabluefish1 04/26/17 11:21:40 AM
#8603   big buy on the bid right now... 40k shares... Psuforlife 04/26/17 10:57:31 AM
#8602   Short squeeze coming ? bustingmyask 04/26/17 10:44:48 AM
#8601   Fresenius is buying AKORN for $4.7 billion.Psforlife I berthabluefish1 04/26/17 09:41:05 AM
#8600   Case of the week 16/2017 andy55q 04/26/17 09:17:47 AM
#8599   biotech48.Cytosorb might be the needed add on with berthabluefish1 04/25/17 10:24:12 PM
#8598   Biotech how many times do I have to htcblue 04/25/17 08:28:02 PM
#8597   In just 10 months at the head of Bsbs12 04/25/17 05:04:47 PM
#8596   htcblue, how can you say nothing positive?Awarded $1M biotech48 04/25/17 03:26:42 PM
#8595   The shorts may get nervous if this continues bustingmyask 04/25/17 03:05:13 PM
#8594   htc - yes stock price has sucked big Psuforlife 04/25/17 01:18:17 PM
#8593   Biotech, what is there positive to write about??? htcblue 04/25/17 12:59:21 PM
#8592   100 May $5 calls just bought today @$0.20. Babykahn 04/25/17 12:36:51 PM
#8589   This should change when the Fresenius expanded partnership berthabluefish1 04/25/17 09:34:15 AM
#8588   $3M for Q1 is not compelling after all Canes16 04/25/17 09:20:25 AM
#8587   Revenue over $3,000,000 for Q1! clints 04/24/17 10:51:09 PM
#8585   Psuforlife have you heard any info about Q1 Sales? berthabluefish1 04/24/17 04:54:33 PM
#8584   Chan said the 3 Main Partners will be berthabluefish1 04/24/17 03:53:59 PM
#8583   When Kathleen baby is bragging about the uplisting coldterdinvestor 04/24/17 03:50:27 PM
#8581   Cars, I don't anticipate Q1 sales growth at Canes16 04/24/17 03:43:17 PM
#8580   Look for a good earnings report as we cars100cars 04/24/17 03:27:14 PM
#8579   Stock market goes up, and we go "NOWHERE". htcblue 04/24/17 01:41:05 PM
#8578   Reprinted from the April 19, 2017, issue of andy55q 04/24/17 09:30:03 AM
#8577   NEWS -- CytoSorbents Awarded $1M Phase II SBIR Paulness 04/24/17 08:46:44 AM
#8576   Filled finally! vinovista 04/21/17 02:54:04 PM
#8575   Very interesting. vinovista 04/21/17 02:47:18 PM
#8574   I have had an order in @ $4.60 vinovista 04/21/17 02:26:48 PM
#8573   Cytosorb Registry Clinical Centers Keep Moving Up 138 berthabluefish1 04/21/17 09:06:09 AM
#8572   checkout SKYLAND Capital... they just increased there Psuforlife 04/20/17 09:32:41 AM
#8571   CTSO target $10...Cytosorbents Corp kiy 04/19/17 08:18:10 PM
#8570   Hi Rocko... You might find the following link raptorjockey 04/19/17 05:36:58 PM
#8569   It might get you to market quicker, but orangecat 04/19/17 10:49:37 AM
#8568   Makes sense. Isn't a short 510k better then? Rockobongo1281 04/19/17 10:44:56 AM
#8567   Article says Cytosorb has been used in more berthabluefish1 04/19/17 10:38:53 AM
#8566   If the medical device is classified as a orangecat 04/19/17 10:36:24 AM
#8564   Can someone please explain, in layman's terms, the Rockobongo1281 04/19/17 10:24:32 AM
#8563   From the article "A large-scale U.S. randomized, controlled orangecat 04/19/17 10:23:13 AM
#8561   New On Facebook HealthCareBusiness Article About Cytosorb! berthabluefish1 04/19/17 10:20:06 AM
#8560   Article by Dr. Chan: Rockobongo1281 04/19/17 10:09:10 AM
#8559   Good part how they will Co-Market Cytosorb with berthabluefish1 04/19/17 10:07:36 AM
#8558   Case of the week 15/2017 andy55q 04/19/17 09:45:24 AM
#8557   A new Shareholders letter is out. After just orangecat 04/19/17 09:24:42 AM
#8556   NEWS -- CytoSorbents 2017 - Propelling the Company Paulness 04/19/17 09:19:38 AM
#8555   Interesting older article bertha, Cytosorb could be used biotech48 04/18/17 09:26:56 PM
#8551   Interesting Older Article.Protein kinase CK2 modulates IL-6 expression berthabluefish1 04/18/17 11:08:50 AM
PostSubject