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Cytosorbents Corporation (CTSO)

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Last Post: 2/27/2015 1:16:45 AM - Followers: 180 - 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 News: CytoSorbents Announces FDA Approval to Commence Initial U.S. Cardiac Surgery Study 02/02/2015 07:00:00 AM
CTSO News: Initial Statement of Beneficial Ownership (3) 01/23/2015 02:22:56 PM
CTSO News: Current Report Filing (8-k) 01/14/2015 05:05:28 PM
CTSO News: CytoSorbents Announces Closing of Public Offering 01/14/2015 09:00:00 AM
CTSO News: Prospectus Filed Pursuant to Rule 424(b)(1) (424b1) 01/09/2015 08:20:33 AM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#6584   Enteral administration of sorbent polymer for treatment and garydaemon 02/27/15 01:16:44 AM
#6583   A patent from jan. 2014 that includes a Ace up my sleeve 02/27/15 12:53:34 AM
#6582   It was not news but research in 2013,that garydaemon 02/26/15 10:31:13 PM
#6581   It was never released as news, it is garydaemon 02/26/15 09:33:14 PM
#6580   UR welcome....we have a winner The_Free_Nebula 02/26/15 07:20:17 PM
#6579   Hey The Free Nebula- Thanks for your charts bkmomail 02/26/15 05:33:32 PM
#6578   90% of the shareholders didn't even know that Paulness 02/26/15 04:49:04 PM
#6577   When it finally comes out it's NEWS. When hopester 02/26/15 04:38:03 PM
#6576   CTSO - nice move consolidation today...It even tasted The_Free_Nebula 02/26/15 04:12:26 PM
#6575   I wouldn't say it was discounted , the Paulness 02/26/15 02:48:57 PM
#6574   Thanks. It's old news so it's been discounted. hopester 02/26/15 02:27:05 PM
#6573   Looks like a 2012/13 case study. Google "Leukocyte orangecat 02/26/15 02:04:16 PM
#6572   Andy- Wonder how current this news is? Haven't hopester 02/26/15 01:29:34 PM
#6571   Yahoo MB andy55q 02/26/15 02:36:43 AM
#6570   Cytosorbents Paulness 02/25/15 11:17:35 PM
#6569   how do you think the market will react pharmeng 02/25/15 10:18:37 PM
#6568   Where did you find this important info? garydaemon 02/25/15 09:17:37 PM
#6567   Andy, It certainly implies that. I hope CTSO someconcerns 02/25/15 08:56:27 PM
#6566   Is a new filter on the horizon? andy55q 02/25/15 08:30:29 PM
#6565   CTSO - nice move today...UBB now $11.20..still lagging The_Free_Nebula 02/25/15 01:43:08 PM
#6564   So Much for my churn threory.. Just a The_Free_Nebula 02/25/15 11:18:25 AM
#6563   Equities researchers at WBB Securities assumed coverage on andy55q 02/25/15 10:48:15 AM
#6562   IL-6 Adsorption Dynamics in Hemoadsorption Beads Studied Using garydaemon 02/24/15 11:05:22 PM
#6561   Will definitely consolidate tomorrow ...churn baby churn The_Free_Nebula 02/24/15 04:36:04 PM
#6560   Agreed. The pause that refreshes may await the hopester 02/24/15 03:29:58 PM
#6559   Doesn't have to break anything today or tomorrow...it The_Free_Nebula 02/24/15 03:19:02 PM
#6558   The old high ( intraday) was $12.86. So hopester 02/24/15 03:10:27 PM
#6557   There is no resistance point at $12... The_Free_Nebula 02/24/15 02:56:27 PM
#6556   Not Shattered yet. Wanta see above $11( $12would hopester 02/24/15 02:54:33 PM
#6555   It just went up another .10 cents please Paulness 02/24/15 02:47:08 PM
#6554   CTSO - continues to out-kick its coverage - The_Free_Nebula 02/24/15 02:46:15 PM
#6553   10+ years as a professional trader leads me BuyMyAsk 02/24/15 02:21:31 PM
#6552   We are in not so violent agreement...blast or The_Free_Nebula 02/24/15 01:58:52 PM
#6551   Yes u said that.But it is technical hopester 02/24/15 01:48:47 PM
#6550   Like I said it fell back on the The_Free_Nebula 02/24/15 01:31:51 PM
#6549   There's resistance of fair size. Just look at hopester 02/24/15 12:38:52 PM
#6548   Not much resistance - remember that pullback/correction was The_Free_Nebula 02/24/15 10:32:28 AM
#6547   We're very close to resistance in the $11-$12 hopester 02/23/15 10:02:33 PM
#6546   Mmmm, an excellent choice. TheDane 02/23/15 09:21:19 PM
#6545   The Balvenie DoubleWood Scoth Whiskey Aged 12 Years The_Free_Nebula 02/23/15 05:45:45 PM
#6544   Add a Kentucky Bourbon andy55q 02/23/15 05:38:30 PM
#6543   CTSO - continues to out-kick its coverage...I really The_Free_Nebula 02/23/15 04:24:35 PM
#6542   Drinking aged bordeauxs, highland singlemalts and watching this SABAI 02/23/15 01:25:55 PM
#6541   Been following this message board for over a ZORRO1968 02/23/15 11:08:52 AM
#6540   Interesting The_Free_Nebula 02/22/15 12:36:36 PM
#6539   Google, "Cytosorb Application in Heart Lung Machine (Diagrammatic andy55q 02/22/15 08:59:57 AM
#6538   The possibilities are huge here and a 10% Paulness 02/21/15 11:24:43 AM
#6537   $25./sh is a reach right now. You're right hopester 02/20/15 08:31:41 PM
#6536   The company is starting to feel like a The_Free_Nebula 02/20/15 08:20:28 PM
#6535   The top of the BB's is exactly where hopester 02/20/15 08:15:55 PM
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