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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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Wiki
CTSO News: Statement of Changes in Beneficial Ownership (4) 08/26/2014 05:15:44 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 08/19/2014 05:57:45 PM
CTSO News: Current Report Filing (8-k) 08/15/2014 05:07:55 PM
CTSO News: Quarterly Report (10-q) 08/12/2014 04:01:30 PM
CTSO News: CytoSorbents to Report Q2 2014 Operating and Financial Results 08/06/2014 09:00:00 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 08/26/2014 05:15:44 PM
PostSubject
#5629   Nah I don't agree lol lol dr_lowenstein 08/26/14 10:44:25 PM
#5628   Thanks. The company seems real good Je3232 08/26/14 10:43:54 PM
#5627   Thanks I Agree lol lol dr_lowenstein 08/26/14 10:43:16 PM
#5626   This company seems puny Je3232 08/26/14 10:35:55 PM
#5625   More insider selling...bad optic continues...Though the guy has The_Free_Nebula 08/26/14 07:21:05 PM
#5624   For someone with your many posts, you sure Paulness 08/26/14 02:53:08 PM
#5623   If that is the case it is strange snow 08/26/14 02:22:25 PM
#5622   More buys today !!! Paulness 08/26/14 01:16:55 PM
#5621   More dumping, huh? BuyMyAsk 08/26/14 12:25:58 PM
#5620   I agree. Great posts. Really helping Je3232 08/25/14 07:19:25 AM
#5618   Didn't say it was the kiss of death The_Free_Nebula 08/25/14 01:10:40 AM
#5617   If it was from all insiders, then yes. rule_rationale 08/25/14 12:30:01 AM
#5616   The constant insider selling is a bad optic The_Free_Nebula 08/24/14 01:24:45 PM
#5615   Bikle- Great find! More great news and more bkmomail 08/23/14 03:49:15 PM
#5614   To this board I copied my post from Bikle 08/23/14 01:12:07 PM
#5613   http://www.investopedia.com/terms/c/cashlessexercise.asp yorky 08/22/14 08:29:38 AM
#5612   He is not increasing his own shares he Paulness 08/21/14 03:22:23 PM
#5611   Mr. Kraus is exercising options and increasing his yorky 08/21/14 03:04:11 PM
#5610   Looks like of all the insiders are holding Paulness 08/21/14 01:33:35 PM
#5609   Cytosorbents Corp (NASDAQ:CTSO) Director Al Kraus unloaded 100,000 woodstock135 08/21/14 01:00:46 PM
#5608   http://www.wkrb13.com/markets/359326/cytosorbents-corp-earns-buy-rating-from-ana Paulness 08/20/14 04:41:20 PM
#5607  Restored Hi guys, I am new to the board Believed 08/20/14 02:23:19 AM
#5606   maybe, maybe not, maybe not Murph1953 08/19/14 10:08:07 PM
#5605   Question: Does anybody know Murph1953 08/19/14 09:48:47 PM
#5604   Not a basher both CTSO and Spectral are chrisgold 08/19/14 08:15:43 PM
#5603   I think they think you are proudamerican79th , Paulness 08/19/14 01:49:51 PM
#5602   Agree with all but the r/s if the The_Free_Nebula 08/19/14 01:34:41 PM
#5601   Everyone on the yahoo board thinks I'm you.. Bobjames 08/19/14 01:21:10 PM
#5600   Bob James is so right its not even BuyMyAsk 08/19/14 12:55:42 PM
#5599   Why is it you think institutions are pounding Bobjames 08/19/14 12:28:34 PM
#5598   Well Biocon is a partner so you are Paulness 08/19/14 11:53:40 AM
#5597   I've been taking a hammering at the Yahoo Bobjames 08/19/14 01:31:15 AM
#5596   CTSO - Don't like long top wick...but hoping The_Free_Nebula 08/18/14 11:20:55 PM
#5595   And your take on CTIX ? Paulness 08/18/14 11:02:43 PM
#5594   Paulness - if you think CTSO fits in BuyMyAsk 08/18/14 10:49:06 PM
#5593   (Institutions make safe bets and take calculated risk). Paulness 08/18/14 09:14:25 PM
#5592   Paulness - the account is a joint account BuyMyAsk 08/18/14 08:53:10 PM
#5591   News Breaks andy55q 08/18/14 08:38:52 AM
#5590   So you sold 5.7 million shares, with all Paulness 08/17/14 08:15:41 PM
#5588   Ping let me explain something. Uplisting is a JOKE. BuyMyAsk 08/17/14 11:12:48 AM
#5587   SABAI - i will explain the answer. BuyMyAsk 08/17/14 11:09:16 AM
#5586   SABAI - I appreciate that post. It is BuyMyAsk 08/17/14 11:03:13 AM
#5585   I think it is a good indication of ping_pow_princess 08/17/14 10:59:40 AM
#5584   I agree with you. I don't think uplisting kegparty 08/17/14 08:45:32 AM
#5583   Ping, im aware of that. thats why i kept SABAI 08/17/14 07:49:08 AM
#5582   You left out the threat of the r/s... The_Free_Nebula 08/17/14 01:55:21 AM
#5581   Sabai, From the Aug 12 transcript regarding up-listing: ping_pow_princess 08/16/14 10:38:53 PM
#5580   i reduced my position in CTSO. Sold 150K SABAI 08/16/14 09:27:09 AM
#5579   May 24, 2013 8:35 am Blood purification device andy55q 08/16/14 08:20:42 AM
#5578   The proposed reverse split is a deterrent to The_Free_Nebula 08/16/14 04:03:54 AM
PostSubject