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Cytosorbents Corporation (CTSO)

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About CytoSorbents, CytoSorb, and HemoDefend

CytoSorbents Corporation is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. In 2011, CytoSorb®, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, allowing it to be sold throughout the European Union (E.U.) under the CE Mark, to be used in clinical situations where cytokines are elevated. The goal of the CytoSorb® cytokine filter is to reduce "cytokine storm" in critically-ill patients that could otherwise lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. The CytoSorb® filter has demonstrated statistically significant reductions in mortality in septic patients at high risk of death in early studies and is now being sold in Germany, Austria and Switzerland for the treatment of critical care illnesses, with availability in other E.U. countries planned in the future, assuming adequate and timely funding, and continued positive results from clinical studies.

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 the blood supply. The HemoDefend technology utilizes the Company's polymer bead technology to remove many substances, such as antibodies, free hemoglobin and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions.

CytoSorb® and HemoDefend are just two of a number of different polymers the Company has designed for various medical applications, including improved dialysis, reduction of post-surgical complications in cardiac surgery, treatment of inflammatory and autoimmune disorders, radio-imaging contrast removal in imaging and interventional radiology procedures, and the treatment of rhabdomyolysis, drug overdose, and others. Additional information is available for download on the Company's website: http://www.cytosorbents.com.

 

CytoSorb® - A First-in-Class Cytokine Filter Approved in the European Union

CytoSorb

CytoSorb® is a potentially breakthrough critical care immunotherapy that attempts to address one of the most challenging unmet medical needs in medicine…the ability to prevent or mitigate multiple organ failure - the leading cause of death in the intensive care unit (ICU) from any cause.

In response to life-threatening conditions such as sepsis and infection, trauma, serious burn injuries, severe lung injury, and pancreatitis, the body frequently overreacts and produces a massive excess of cytokines, or “cytokine storm”. Cytokines normally help the body cope with injury, but at these levels, cytokine storm is toxic to the body, driving severe inflammation and a cascade of pathophysiologic changes in the body that cause cell damage, organ failure and often death. It follows that reduction of cytokine storm may limit this cascade of events, thereby reducing the severity of illness, and helping patients recover and survive. Until recently, however, there were no effective ways to reduce cytokine storm broadly.

CytoSorb® is a first-in-class extracorporeal cytokine filter, now approved in the European Union, and broadly indicated for use in any clinical situation where cytokines are elevated. It is compatible with standard hemodialysis machines and blood pumps found in most hospitals. Blood is pumped out of the body, through the CytoSorb® cartridge that contains the company’s proprietary blood compatible porous polymer beads, and the “purified” blood is recirculated back to the patient. In a six hour period, a patient's entire blood volume can be treated approximately 20 times.

CytoSorb® is clinically proven to reduce cytokine storm in the company's multi-center, randomized, controlled European Sepsis Trial conducted in Germany. Treatment was safe and well-tolerated in more than 300 human treatments in very sick patients with the worst forms of sepsis and lung injury, and treatment has been safe in nearly 1,500 human treatments overall. Early data suggests that CytoSorb® can reduce organ injury and improve survival in patients at high risk of cytokine injury, particularly those patients with very high cytokine levels, and patients older than age 65.

CytoSorb® has now been used successfully in many conditions where deadly inflammation can lead to organ injury and failure. We are seeing strong interest in the following clinical applications:

Applicatons

There are more than 100 key opinion leaders in Germany, Austria, and Switzerland (our direct sales territories) who are either using or committed to using CytoSorb in clinical practice or clinical studies. More than 30 investigator-initiated studies in a diverse set of applications are being planned, with many already enrolling patients. In the United States, the U.S. Air Force is funding a 30-patient, FDA-approved randomized controlled human trauma pilot study.

As these other independent studies progress, CytoSorbents collaborates with Dr. John Kellum at the University of Pittsburgh Medical Center, and is sponsoring clinical studies in the area of severe sepsis and septic shock, the result of an overzealous immune response to a severe infection such as pneumonia or a ruptured appendix. Severe sepsis and septic shock are collectively a top ten cause of death worldwide, afflicting approximately 27 million people annually, killing approximately 1 in 3 patients despite the best medical care. CytoSorbents is conducting clinical trials in Europea and currently has an FDA-approved IDE application to run a small sepsis trial in the U.S.. The company will look to conduct a U.S. pivotal sepsis study in the future as a key step towards U.S. FDA approval.

Because of the versatility of CytoSorb®, there are many other potential applications of the technology outside of critical care medicine as well. In particular, CytoSorb® has been used many times intraoperatively during open heart surgery, where the heart must be stopped in order to operate on it, while the blood is pumped outside of the body by a heart-lung machine that oxygenates the blood and pumps it back to the rest of the body. This procedure can result in the production of inflammatory mediators such as cytokines, as well as hemolysis and the release of free hemoglobin into the blood. This can result in inflammation and post-operative complications such as failure to wean from mechanical ventilation and kidney failure. There are more than 1 million open heart surgeries each year in the U.S. and E.U. combined, with an addressable market of more than $1 billion for CytoSorb®.

Another application is in cancer immunotherapy. Cancer cachexia is a wasting condition that occurs in most cancers that leads to rapid uncontrolled weight loss, anorexia, and physical debilitation. Patients lose the physical reserve needed to tolerate treatment and fight the cancer. Because CytoSorb® can remove a broad range of cytokines and other inflammatory mediators that drive cancer cachexia, it may be very helpful in this condition. CytoSorbents is exploring this application, as well as the use of CytoSorb® as a primary cancer immunotherapy to kickstart the immune system to attack cancer, with researchers at the University of Pennsylvania School of Veterinary Medicine.

CytoSorb® is being sold for clinical use in the European Union and in countries outside of the European Union that accept European CE Mark approval such as India, Russia, Turkey and others. The total addressable market for CytoSorb® in critical care applications such as sepsis, burn injury, trauma, ARDS, pancreatitis and other diseases is estimated at $10-15 Billion in the U.S. and Europe alone.

 

From Shareholder's Letter

Goals for 2014

We have laid out an ambitious, yet potentially achievable, agenda for the next two years. Some of our highest priorities are:

  • Greater awareness of our story and technology through increased media exposure and improved investor relations
  • Revenue growth and increased product adoption in our direct sales territories
  • Distributor agreements for CytoSorb in Europe and elsewhere
  • Strategic partnerships for our pipeline products
  • Non-dilutive funding from grants and other programs
  • Commencement of a U.S. based trial
  • Clinical data and new clinical applications with data being presented at key scientific conferences
  • Improving liquidity and institutional sponsorship of our stock with potential up-listing to a national stock exchange


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CTSO
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CTSO News: Statement of Changes in Beneficial Ownership (4) 05/26/2015 03:04:08 PM
CTSO News: CytoSorbents to Present at the LD Micro Invitational on June 1st 05/26/2015 07:00:00 AM
CTSO News: CytoSorbents and Alphamedix Team To Introduce CytoSorb® to Israel 05/19/2015 09:04:00 AM
CTSO News: CytoSorbents and Alphamedix Team To Introduce CytoSorb® to Israel 05/19/2015 08:31:00 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 05/18/2015 05:21:23 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 05/26/2015 03:04:08 PM
PostSubject
#7161  Sticky Note Recap of 2015 so far andy55q 05/19/15 07:46:11 AM
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#7177   I would be the first to admit this Karlandang 05/26/15 09:35:02 PM
#7176   SH meeting. Who is going? I am. andy55q 05/26/15 09:17:00 PM
#7175   More $$$ out of the window for pumping SABAI 05/26/15 11:52:53 AM
#7174   All patients experienced cytokine release syndrome (CRS). Of andy55q 05/26/15 09:57:02 AM
#7173   NEWS -- CytoSorbents to Present at the LD Paulness 05/26/15 08:32:11 AM
#7172   EXPORT DATA-USA andy55q 05/24/15 11:38:12 AM
#7171   Techno Orbits Featuring CytoSorb on Web Page andy55q 05/22/15 12:46:52 PM
#7170   LOL, das war eine rhetorische Frage..... Die Partner SABAI 05/20/15 12:09:23 AM
#7169   Do your own DD!! janosch57 05/19/15 04:30:20 PM
#7168   This study has been completed. ClinicalTrials.gov andy55q 05/19/15 03:03:57 PM
#7167   And the italy guys? SABAI 05/19/15 01:33:33 PM
#7166   Cytosorb Registry-PARTICIPATING CLINICAL CENTERS andy55q 05/19/15 01:00:29 PM
#7165   Biocon added $250k usd through April 2015. Babykahn 05/19/15 12:32:17 PM
#7164   Fluff, what did Biocon or Aferetica add to SABAI 05/19/15 10:26:03 AM
#7163   Readmissions in severe sepsis are as common as andy55q 05/19/15 10:21:25 AM
#7162   NEWS -- CytoSorbents and Alphamedix Team To Introduce Paulness 05/19/15 09:41:52 AM
#7161   Recap of 2015 so far andy55q 05/19/15 07:46:11 AM
#7160   FYI - I couldn't sticky it since it eColi 05/18/15 04:13:27 PM
#7159   The short interest in this stock is extremely BuyMyAsk 05/18/15 03:40:03 PM
#7158   Yes I saw that. Lots of the BuyMyAsk 05/18/15 02:48:06 PM
#7157   Institutional now up to 30 rdgere 05/18/15 09:40:22 AM
#7156   Jena University Hospital-World Rank #49, #6 in Germany andy55q 05/17/15 12:14:25 PM
#7155   Immunosuppression after Sepsis: Systemic Inflammation and Sepsis Induce andy55q 05/17/15 11:52:45 AM
#7154   CTSO Chart conix 05/16/15 08:35:01 AM
#7153   Can you sticky note my post #7143 to ping_pow_princess 05/15/15 06:54:30 PM
#7152   Andy's rate of return for the time he BuyMyAsk 05/15/15 01:42:39 PM
#7151   Head of FDA's device arm says agency aims andy55q 05/15/15 01:37:43 PM
#7150   Do you realize most of the items you BuyMyAsk 05/15/15 12:06:16 PM
#7149   I think I saw that the cash would ping_pow_princess 05/15/15 11:27:38 AM
#7148   You're post is ridiculous and is an example BuyMyAsk 05/15/15 09:44:14 AM
#7147   Ping, very impressiv, great job! Reading thru your caesare74 05/15/15 09:00:56 AM
#7146   New on CytoSorbents Facebook andy55q 05/15/15 07:37:56 AM
#7145   Testimonials-Videos andy55q 05/15/15 07:34:13 AM
#7144   ping This sounds very impressive. It is all the snow 05/15/15 05:00:51 AM
#7143   Recap of 2015 so far ping_pow_princess 05/14/15 11:47:20 PM
#7142   17 Institutional holders now registered on Nasdaq, I biotech48 05/14/15 05:01:51 PM
#7141   NO - you are actually skewing what you BuyMyAsk 05/14/15 04:48:41 PM
#7140   It is useless pumping at this point because Believed 05/14/15 04:20:36 PM
#7139   Congrats on pumping another worthless stat. 17 BuyMyAsk 05/14/15 02:27:53 PM
#7138   17 Institutional holders now registered on Nasdaq Believed 05/14/15 02:25:18 PM
#7137   Call it as you may. For a BuyMyAsk 05/14/15 02:04:51 PM
#7136   Testimonials Professor John Kellum, University of Pittsburgh, US andy55q 05/14/15 01:57:16 PM
#7135   Just thinking out loud about that recent article Murph1953 05/14/15 01:18:28 PM
#7134   Motality v. cytokines. Why? Murph1953 05/14/15 01:05:17 PM
#7133   Chan said "28 day ALL CAUSE mortality" is Babykahn 05/14/15 11:56:37 AM
#7132   now that CTSO has dipped to the support alien42 05/14/15 11:43:02 AM
#7131   Andy you are honestly doing a disservice to BuyMyAsk 05/14/15 10:18:46 AM
#7130   I showed my account on Scottrade showing over BuyMyAsk 05/14/15 10:17:23 AM
#7129   Dont fall in love with ANY stock... SABAI 05/14/15 10:02:57 AM
#7128   Cytosorb Nederland Facebook andy55q 05/14/15 07:59:22 AM
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