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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 News: Statement of Changes in Beneficial Ownership (4) 10/16/2014 03:14:12 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 10/16/2014 02:13:05 PM
CTSO News: Current Report Filing (8-k) 10/14/2014 04:59:45 PM
CTSO News: CytoSorbents Wins 2014 GREAT Tech Award In Health 10/10/2014 06:00:00 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 10/08/2014 11:34:52 AM
PostSubject
#5908   With P^3's post #5899, the next few days Murph1953 10/21/14 01:25:43 PM
#5907   Ebola in Africa - Ebola in Germany andy55q 10/21/14 12:22:47 PM
#5906   After the RS there are only about 60M SABAI 10/21/14 10:41:50 AM
#5905   Wow! What filter are they using on the andy55q 10/21/14 07:50:29 AM
#5904   That's great but it's the 600 million shares laker5 10/21/14 06:16:44 AM
#5903   " transfusion of packed red blood cells (PRBCs) Makenlight 10/20/14 09:42:10 AM
#5902   CytoSorbents rises as buy rating reaffirmed by H.C. andy55q 10/19/14 12:57:06 PM
#5901   http://topequitynews.com/cytosorbents-rises-as-buy-rating-reaffirmed-by-h-c-wain WishfulThinking1 10/19/14 09:51:24 AM
#5900   Thanks for all your contributions. Great to WishfulThinking1 10/18/14 11:46:04 PM
#5899   New options for patients with severe SIRS and ping_pow_princess 10/18/14 08:13:08 PM
#5898   It' is wishful thinking.... The_Free_Nebula 10/18/14 11:06:58 AM
#5897   Yes somebody has to add some coulor. But Bikle 10/18/14 10:23:29 AM
#5896   Can someone add some color to this as andy55q 10/18/14 08:27:41 AM
#5895   Death, hemorrhage, and viremia were independently associated with Sepsis Survival 10/18/14 07:06:54 AM
#5894   He did that crap to so many up Paulness 10/17/14 09:26:13 PM
#5893   This guy is also a piece of work, IL-6 10/17/14 08:13:54 PM
#5892   Sure sounds like him!! andy55q 10/17/14 08:06:16 PM
#5891   You are quite a piece of work. Deleting IL-6 10/17/14 07:51:54 PM
#5890   Maybe BMA is Adam F? Babykahn 10/17/14 06:53:54 PM
#5889   Sales say it all ,EU loves cytosorb Paulness 10/17/14 05:22:18 PM
#5888   This was translated from German to English,so it andy55q 10/17/14 04:21:24 PM
#5887   ADDING Wanted to throw that in before people started BuyMyAsk 10/17/14 03:42:47 PM
#5886   I am hysterically laughing about how everyone is BuyMyAsk 10/17/14 03:28:35 PM
#5885   http://www.exposeadam.com/ Believed 10/17/14 02:33:40 PM
#5884   nvermind, found the AF stuff on Yahoo amelow 10/17/14 02:18:22 PM
#5883   didn't see the mention of aDam F but amelow 10/17/14 01:41:50 PM
#5882   Adam F - why would someone drag him Babykahn 10/17/14 12:08:50 PM
#5881   Ebola in Africa - Ebola in Germany / andy55q 10/17/14 11:11:36 AM
#5880   Ebola Patient Treated With Investigational Blood Filtration Device andy55q 10/17/14 10:59:09 AM
#5879   Looks like a green open is in store... The_Free_Nebula 10/17/14 09:28:22 AM
#5878   This one looks close to completion. Paulness 10/16/14 10:58:46 PM
#5877   Andy55q- Nice find! Thank you. bkmomail 10/16/14 10:20:10 PM
#5876   New Study posted today on FDA site. andy55q 10/16/14 07:34:45 PM
#5875   They are selling product The_Free_Nebula 10/16/14 06:02:52 PM
#5874   I see thanks for the explanation. I noticed sillylung 10/16/14 04:49:45 PM
#5873   Obviously there was other news like the million Paulness 10/16/14 04:46:06 PM
#5872   Why do insiders sell every freaking week? I've sillylung 10/16/14 03:44:51 PM
#5871   There are lethal pathogens/infections out there which do Murph1953 10/16/14 01:35:19 PM
#5870   I got to say that once EBOLA was Paulness 10/16/14 01:14:52 PM
#5869   The last thing this message board will become BuyMyAsk 10/16/14 12:57:29 PM
#5868   Let me explain something to you BuyMyAsk 10/16/14 12:55:54 PM
#5867   BuyMyAsk- I want you to know that if bkmomail 10/16/14 12:36:11 PM
#5866   Dr. Chan has said everything under the sun. BuyMyAsk 10/16/14 11:13:16 AM
#5865   Dude...you somehow got to be a mod here Bloat Dastardly 10/16/14 10:56:14 AM
#5864   The reception of the HemoDefend technology at the Makenlight 10/16/14 10:33:10 AM
#5863   "We continue to believe that our therapy Makenlight 10/16/14 10:27:05 AM
#5862   Paulness - can you please share the link BuyMyAsk 10/16/14 10:16:45 AM
#5861   Don't remove the posting of Andy! Bikle 10/16/14 09:46:40 AM
#5860   Spam?-Tell that to Dr Chan. andy55q 10/16/14 09:14:46 AM
#5858   HemoDefend™ is a late-development stage technology platform that Paulness 10/15/14 10:22:35 PM
PostSubject