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Cytosorbents Corporation (CTSO)

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Last Post: 4/1/2015 5:36:57 PM - Followers: 178 - Board type: Free - Posts Today: 0
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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Option Chain for CTSO
CTSO News: Why Cytosorbents Corp Shares Burst Today 04/01/2015 01:32:40 PM
CTSO News: Cytosorbents ups revenues 71% in FY14 04/01/2015 06:34:28 AM
CTSO News: CytoSorbents Reports Record 2014 Revenue 03/31/2015 04:50:00 PM
CTSO News: Annual Report (10-k) 03/31/2015 04:16:32 PM
CTSO News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 03/31/2015 01:37:41 PM
News News Alert: Why Cytosorbents Corp Shares Burst Today 04/01/2015 01:32:40 PM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#6791   Maybe there is a shot of something from pharmeng 04/01/15 05:36:57 PM
#6790   CTSO - Short term false adversity breeds a The_Free_Nebula 04/01/15 03:10:22 PM
#6789   Next 1 to 3 months? BuyMyAsk 04/01/15 02:24:43 PM
#6788   und du lügst wie gedruckt, du hast nie janosch57 04/01/15 01:45:30 PM
#6785   You can say all you want. No BuyMyAsk 04/01/15 12:00:00 PM
#6784   Now that all the nervous nellies are gone Paulness 04/01/15 11:59:27 AM
#6781   No, no, no, no, NO! BuyMyAsk 04/01/15 10:27:34 AM
#6780   The most important factor which appears to be AARONSACESS 04/01/15 10:13:53 AM
#6779   I like your take much better...In the end The_Free_Nebula 04/01/15 10:08:28 AM
#6778   Listen I am not telling you the stock BuyMyAsk 04/01/15 10:08:13 AM
#6777   OK...I will bow to your Kung Fu on The_Free_Nebula 04/01/15 10:03:18 AM
#6776   Let me explain myself. BuyMyAsk 04/01/15 10:00:04 AM
#6775   Buy My Ask- The assumption that the product hopester 04/01/15 09:57:51 AM
#6774   I think you are making that stretch connection...I The_Free_Nebula 04/01/15 09:47:03 AM
#6773   Stock has lost significant value over night due BuyMyAsk 04/01/15 09:32:19 AM
#6772   I am talking about folks who sold AH The_Free_Nebula 04/01/15 09:14:28 AM
#6771   You do add value on this board with BuyMyAsk 04/01/15 09:13:38 AM
#6770   Seems to me that the reaction was quite The_Free_Nebula 04/01/15 08:36:48 AM
#6769   I was expecting consistent Q over Q revenue Babykahn 04/01/15 07:36:49 AM
#6768   Classic over reaction....buy op....nasty though....don't know what folks The_Free_Nebula 03/31/15 10:33:27 PM
#6767   Cytosorb Registry andy55q 03/31/15 10:24:37 PM
#6766   LOL wow, what a wonderful company. Billion in revenues....ooops!! dr_lowenstein 03/31/15 10:01:01 PM
#6765   "Missed it by that much", as Maxwell Smart Astavakra 03/31/15 09:33:37 PM
#6764   Well i have a load of cash ready BuyMyAsk 03/31/15 08:34:24 PM
#6763   Tomorrow's a washout day. I'm bringing an empty pail. hopester 03/31/15 07:52:36 PM
#6762   You are spot on... If we had clinical BuyMyAsk 03/31/15 07:51:15 PM
#6761   It hit $5.00 in after hours..... Now its BuyMyAsk 03/31/15 07:47:25 PM
#6760   BMA, I think it was a good call pharmeng 03/31/15 07:47:21 PM
#6759   The volatility is crazy... My $7.70 went BuyMyAsk 03/31/15 07:46:12 PM
#6758   If it hits the $6's watch for me hopester 03/31/15 07:45:18 PM
#6757   You have to understand the stock price at BuyMyAsk 03/31/15 07:25:37 PM
#6756   I view it as a hiccup on a hopester 03/31/15 07:09:04 PM
#6755   Simple. Market cap value was based on Babykahn 03/31/15 06:58:54 PM
#6754   Name the fundamentals today that are so different hopester 03/31/15 06:48:13 PM
#6753   I sold in AH at 12.26 and a BuyMyAsk 03/31/15 06:47:22 PM
#6752   I could not agree more with your post. BuyMyAsk 03/31/15 06:26:59 PM
#6751   I believe this aftermarket is an over-reaction. It's hopester 03/31/15 06:18:33 PM
#6750   Even with q1 adjusted for euro, q1 rev Babykahn 03/31/15 06:02:12 PM
#6749   I didn't think the report was so bad hopester 03/31/15 05:52:29 PM
#6748   This is terrible... pharmeng 03/31/15 05:45:56 PM
#6747   Not arguing, just saying that I evaluate these rule_rationale 03/31/15 05:36:39 PM
#6746   I cannot believe you are arguing with me. BuyMyAsk 03/31/15 05:30:52 PM
#6745   Is your reply joking? Sorry, maybe your definition rule_rationale 03/31/15 05:26:29 PM
#6744   Let me explain something. How can you BuyMyAsk 03/31/15 05:17:39 PM
#6743   Long term investment thesis has not been impacted, rule_rationale 03/31/15 05:11:00 PM
#6742   I am telling you now... Sell in the BuyMyAsk 03/31/15 05:04:52 PM
#6741   Never wanna see a slide that says "near Babykahn 03/31/15 05:01:53 PM
#6740   Sales were around $850K for the quarter I believe. BuyMyAsk 03/31/15 04:27:04 PM
#6739   Thanks for your insight, always apreciated?? SABAI 03/31/15 03:34:06 PM
#6738   The short volume numbers are distorted. Market BuyMyAsk 03/31/15 03:22:49 PM
PostSubject