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Cytosorbents Corporation (CTSO)

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Last Post: 8/17/2017 7:38:34 PM - Followers: 179 - Board type: Free - Posts Today: 0

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
#9615   Great Post - thanks !!! andy55q 08/17/17 07:38:34 PM
#9614   Weimar Sepsis Update 2017 techxen 08/17/17 06:02:12 PM
#9612   http://www.americanlaboratory.com/914-Application-Notes/340464-An-Effective-Trea orangecat 08/17/17 11:51:02 AM
#9611   Ric Flair is in critical condition with "multiple andy55q 08/17/17 09:15:33 AM
#9610   CRRT is a complex intervention.Delivery requires many berthabluefish1 08/17/17 09:15:14 AM
#9608   Fresenius are real pros, they do it right! BorisBeckar 08/16/17 10:25:45 PM
#9607   Fresenius has been ramping up for over 2 coldterdinvestor 08/16/17 08:50:19 PM
#9606   Awesome stuff Techan! Insider holdings comparison BorisBeckar 08/16/17 05:17:17 PM
#9605   Excellent post! Thanks Techxen. dp60 08/16/17 12:55:21 PM
#9604   Top 25 university clinics in Germany, current overview: Aliberto 08/16/17 11:52:06 AM
#9603   VAMED is a global provider for hospitals and techxen 08/16/17 10:39:12 AM
#9602   Thank you. Where did you find this ?? andy55q 08/15/17 09:51:40 PM
#9601   UKSH is one of the largest university hospitals techxen 08/15/17 09:10:55 PM
#9594   Sure looks like they are hooking up Cytosorb berthabluefish1 08/15/17 09:23:39 AM
#9593   Case of the week 32/2017 andy55q 08/15/17 09:11:43 AM
#9592   "....In Europe, it looks similar: with the accelerating Aliberto 08/15/17 06:36:43 AM
#9591   I'm most excited about the upcoming REFRESH 1 BorisBeckar 08/14/17 11:59:30 PM
#9590   One third of sales are not coming from biotech48 08/14/17 11:33:46 PM
#9589   One hospital in Germany already generates over $1M pearsby09 08/14/17 06:29:45 PM
#9587   Bertha, good remark. Seems that the US military caesare74 08/14/17 01:57:59 PM
#9584   Novartis CLT019 Cart T cell Therapy.Cytosorbent's Advisory board,also berthabluefish1 08/14/17 11:42:30 AM
#9583   New Article out from Brian Marckx on yahoo.Make berthabluefish1 08/14/17 11:29:43 AM
#9582   All, fwiw, dp60 08/14/17 10:11:24 AM
#9581   From the Call last week.Based on what we berthabluefish1 08/14/17 09:40:12 AM
#9579   Current usage far more important than clinical proof BorisBeckar 08/14/17 09:19:38 AM
#9578   CytoSorbents Awarded $719,000 Grant To Acutely Stabilize Severe dah174174 08/14/17 08:02:47 AM
#9577   I'm at 4.73. Some 8 cent shares in orangecat 08/13/17 12:44:31 PM
#9576   Sentiment about ole chanie has changed a lot coldterdinvestor 08/13/17 10:26:05 AM
#9575   I am sure many bought above 10. pearsby09 08/13/17 09:09:22 AM
#9574   What if you bought at 15.00 ? J G R 08/13/17 08:56:19 AM
#9573   That's where I made my mistake, I stood ml24 08/13/17 04:44:12 AM
#9572   I remember not that long ago CTSO was timflos22 08/12/17 05:21:38 AM
#9571   At a 5.10 cost basis in this stock pearsby09 08/11/17 09:17:46 PM
#9570   Easy pears, Ben in this stock a long ml24 08/11/17 06:01:30 PM
#9569   The history definitely does effect the present and pearsby09 08/11/17 05:25:02 PM
#9567   No exciting news coming from Wall Street slappie 08/11/17 11:20:22 AM
#9566   Why throw good money after bad. As coldterdinvestor 08/11/17 11:15:38 AM
#9564   Data, schmata, who cares, after 7 years of coldterdinvestor 08/11/17 10:08:13 AM
#9563   We have some exciting data coming out from berthabluefish1 08/11/17 09:34:10 AM
#9562   All that means is they have grabbed off coldterdinvestor 08/11/17 09:16:52 AM
#9561   Thanks Andy... this is a great HadToHavit 08/10/17 10:30:50 PM
#9560   Government grant funding history andy55q 08/10/17 06:52:05 PM
#9559   That is what an anecdotal case study approach pearsby09 08/10/17 02:30:00 PM
#9558   Agreed. For six years that has been the dr_lowenstein 08/10/17 12:32:09 PM
#9557   From the Conclusion: pearsby09 08/10/17 12:28:40 PM
#9556   This is an interesting case, it illustrates how biotech48 08/10/17 09:45:39 AM
#9555   Use of Hemadsorption in a Case of Pediatric andy55q 08/10/17 08:37:45 AM
#9554   New PubMed.Use of Hemadsorption In Case of Pediatric berthabluefish1 08/10/17 07:12:54 AM
#9552   ah, rumors from unnamed sources- very credible, thanks dr_lowenstein 08/09/17 10:35:17 PM
#9551   Why I believe CTSO will soar and soar high!! BorisBeckar 08/09/17 10:19:59 PM
PostSubject