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Cytosorbents Corporation (CTSO)

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Last Post: 7/20/2017 11:01:05 PM - Followers: 180 - 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) 07/06/2017 05:22:56 PM
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
PostSubject
#9323   New On Facebook.Frost & Sullivan Awards Gala Cytosorbents! berthabluefish1 07/20/17 11:01:05 PM
#9322   Interesting On PubMed.High systemic IL-6 is associated with berthabluefish1 07/20/17 07:40:25 PM
#9321   CytoSorbents Corporation, Inst Holders, 2Q 2017 (CTSO) dah174174 07/20/17 09:24:06 AM
#9320   Novartis plans to submit an application with the berthabluefish1 07/18/17 10:25:21 PM
#9319   Weak dollar should start helping us going forward Psuforlife 07/18/17 03:59:24 PM
#9318   Notice the 3rd sentence in the last paragraph.Met berthabluefish1 07/18/17 01:20:28 PM
#9317   CytoSorb® Treatment of HLH - The Parallel to andy55q 07/18/17 12:20:15 PM
#9316   "Just the child cancer market for Novartis is Aliberto 07/18/17 12:06:23 PM
#9315   Just the child cancer market for Novartis is berthabluefish1 07/18/17 11:54:14 AM
#9314   sure there is, zero evidence of any interest dr_lowenstein 07/18/17 11:46:32 AM
#9313   there is not one iota of evidence that biotech48 07/18/17 10:25:07 AM
#9311   there is not one iota of evidence that dr_lowenstein 07/18/17 10:00:55 AM
#9310   CTSO's "Swiss Connection" to NVS and Car-T cell cars100cars 07/18/17 09:10:03 AM
#9309   Miami, United States / AFP / A cancer andy55q 07/18/17 06:55:23 AM
#9308   LOL LOL ok, sure dr_lowenstein 07/18/17 12:39:00 AM
#9307   Bret Jensen biotech48 07/18/17 12:36:26 AM
#9306   New Article 6 hrs ago AFP.Promising Immunotherapy Helps berthabluefish1 07/17/17 10:56:51 PM
#9305   CTSO does not pay Bret Jensen for his articles. dr_lowenstein 07/17/17 10:43:21 PM
#9304   CTSO does not pay Bret Jensen for his biotech48 07/17/17 10:41:12 PM
#9303   I agree totally. Think globally, not locally. Astavakra 07/17/17 06:49:39 PM
#9301  Restored More paid promotional crap dr_lowenstein 07/17/17 04:35:18 PM
#9300   Cars, with all due respect. The market pearsby09 07/17/17 04:11:21 PM
#9299   SEEKING ALPHA TODAY ON CTSO dah174174 07/17/17 03:04:36 PM
#9298   Look beyond the US border BorisBeckar 07/17/17 01:48:46 PM
#9297   Pears, think globally because CytoSorb is approved in cars100cars 07/17/17 11:23:16 AM
#9295   I disagree pearsby, the device is approved for biotech48 07/17/17 10:37:11 AM
#9294   Third Party, HMO's, Government (Medicaid/Medicare), ect... will not pearsby09 07/17/17 10:21:00 AM
#9293   NEWS -- CytoSorbents Expands Distribution and Sales of Paulness 07/17/17 09:39:00 AM
#9292   Pears, Car-T can cause a short-term inflammation crisis cars100cars 07/17/17 09:30:26 AM
#9291   New Partnership - Panama Rockobongo1281 07/17/17 09:21:40 AM
#9290   The company is not targeting all cancer's, they biotech48 07/16/17 11:05:44 PM
#9289   Cancer is many times chronic and long term, pearsby09 07/16/17 08:40:05 PM
#9288   Zacks prior notes: andy55q 07/16/17 12:28:33 PM
#9287   Positive news? Do you think your CEO is dr_lowenstein 07/15/17 07:37:28 PM
#9286   Big positive news and a short squeeze sounds orangecat 07/14/17 09:13:47 PM
#9285   I agree, and the recent insider buys may twointen 07/14/17 04:58:19 PM
#9284   Looks like some real good news coming.IMO I berthabluefish1 07/14/17 11:58:51 AM
#9283   FROM CTSO JUST NOW ON FACEBOOK dah174174 07/14/17 09:53:29 AM
#9282   https://www.google.com/amp/s/www.bloomberg.com/amp/news/articles/2017-07-14/amer andy55q 07/14/17 09:22:25 AM
#9281   America Has A $27 Billion Sepsis Crisis.Bloomberg 5 berthabluefish1 07/14/17 09:10:57 AM
#9280   Thanks I think BorisBeckar 07/13/17 11:00:05 PM
#9279   Brilliant! This is an excellent, unexpected (by dp60 07/13/17 10:46:42 PM
#9277  Restored These beads cure the disease called accumulation of dr_lowenstein 07/13/17 04:15:19 PM
#9276   Really what medical authority has proclaimed it the dr_lowenstein 07/13/17 04:00:53 PM
#9275   Is there anything these beads don't cure? coldterdinvestor 07/13/17 03:43:34 PM
#9274   Cytosorb is the best all around treatment in berthabluefish1 07/13/17 03:40:45 PM
#9273   If the company is promoting this it is dr_lowenstein 07/13/17 02:03:55 PM
#9272   Every medical condition could be huge for us BorisBeckar 07/13/17 01:49:34 PM
#9271   They just sent this http://www.fiercebiotech.com/biotech/safety-priority-for-nov greenaccountingbeen 07/13/17 01:02:31 PM
#9270   Wow just saw it Rock! berthabluefish1 07/13/17 12:57:29 PM
PostSubject