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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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Option Chain for CTSO
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
CTSO News: Notice of Effectiveness (effect) 01/09/2015 06:01:40 AM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#6456   Hi Dianne, I have had some CTSO for Drano 01/29/15 12:40:15 PM
#6455   Hi Drano...Nice to see you here. diannedawn 01/29/15 12:37:00 PM
#6454   CYTOSORB ON THE DGTHG SYMPOSIUM 8-02/11/15 IN FREIBURG andy55q 01/29/15 08:06:28 AM
#6453   Cytosorb Netherlands andy55q 01/29/15 07:52:54 AM
#6452   IDE application filed 12/29/14 and today marked 30 Crcook 01/29/15 12:09:06 AM
#6451   Just a photo? You have something else to share? andy55q 01/28/15 03:52:57 PM
#6450   Yes ysung, there was a 25:1 R/S in eColi 01/28/15 03:49:33 PM
#6449   http://www.cytosorb-registry.org/wp-content/uploads/2014/07/Postop_Nierenersatz. SABAI 01/28/15 03:12:45 PM
#6448   There would be a huge market for ShortSellerSorb. Drano 01/28/15 03:05:34 PM
#6447   Did this co do R/S recently ? ysung 01/28/15 02:43:35 PM
#6446   Potential catalysts: andy55q 01/28/15 02:23:54 PM
#6445   No liquidity and absurd spreads in the options Drano 01/28/15 12:58:49 PM
#6444   Wow like the numbers. eddy2 01/27/15 10:13:53 PM
#6443   http://www.microsofttranslator.com/BV.aspx?ref=IE8Activity&a=http%3A%2F%2Fwww.sp garydaemon 01/27/15 09:31:46 PM
#6442   translate? Jan.5, 2015 Murph1953 01/27/15 09:20:20 PM
#6441   I believe Fresenius now owns their dialysis division. garydaemon 01/27/15 07:33:04 PM
#6440   Gambro Slovakia andy55q 01/27/15 03:43:41 PM
#6439   36. Internationales Symposium. - 15 Jahre St. Anton-Team andy55q 01/27/15 03:19:36 PM
#6438   The GSA launches the Global Sepsis Awards / andy55q 01/27/15 11:23:56 AM
#6437   CTSO reiterated as a buy at H.C.Wainwright dah174174 01/27/15 08:30:07 AM
#6436   From Yahoo MB-German Article andy55q 01/27/15 08:16:51 AM
#6435   They are making models for surgeons to practice Drano 01/27/15 12:11:46 AM
#6434   pharmeng- Thanks for your interesting and thoughtful reply. bkmomail 01/26/15 09:57:21 PM
#6433   I don't think it's very applicable. It would pharmeng 01/26/15 07:00:30 PM
#6432   Interesting article. I'm wondering if there is a bkmomail 01/26/15 12:48:51 PM
#6431   Can CAR-T Therapy Live Up To The Biotech Murph1953 01/26/15 12:19:59 PM
#6430   Was doing some reading and came across a pharmeng 01/25/15 07:47:41 PM
#6428   CytoSorbents Receives $385,000 in Non-Dilutive Funding dah174174 01/23/15 09:25:58 AM
#6425   Take the time to review the distributor from andy55q 01/21/15 07:57:52 PM
#6423   Quiet before the storm......im rdy ! Are you? ;-)GLA SABAI 01/21/15 02:25:14 PM
#6422   Quiet Period has officially ended, according to CTSO mikesmith999945 01/21/15 11:37:40 AM
#6421   When do you expect the shareholder letter? IL-6 01/21/15 11:12:34 AM
#6420   That's why Brean Capital could reiterate their buy dah174174 01/21/15 10:16:51 AM
#6419   Per facebook the quiet period has ended. IL-6 01/21/15 09:47:26 AM
#6418   Newlife Hospital Facebook page andy55q 01/21/15 08:00:42 AM
#6417   Brean Capital Comments On Cytosorbents Following Public Offering dah174174 01/21/15 05:58:50 AM
#6416   This is great!!! Paulness 01/20/15 04:36:42 PM
#6415   AFERETICA-They list CYTOSORB on their site. How about andy55q 01/20/15 04:03:46 PM
#6414   No way someone is buying 40K shares at BuyMyAsk 01/20/15 02:32:19 PM
#6413   40K block at ask 8.25. Looks like secondary SABAI 01/20/15 01:04:46 PM
#6411   http://www.nasdaq.com/press-release/merriman-capital-acted-as-comanager-in-cytos IL-6 01/20/15 09:19:22 AM
#6410   26-year-old newlywed dies from flu, sepsis complications andy55q 01/20/15 08:20:53 AM
#6409   36. Internationales Symposium - 15 Jahre St. Anton-Team andy55q 01/20/15 07:59:09 AM
#6408   It appears this is the same as: andy55q 01/19/15 10:04:20 AM
#6407   http://www.imise.uni-leipzig.de/Projekte/Klinische-Studien/CytoSorb/index.jsp SABAI 01/19/15 03:19:40 AM
#6406   35th International Symposium on Intensive Care and Emergency Medicine ping_pow_princess 01/18/15 03:02:49 PM
#6405   22. Januar 2015, 18.30 Uhr ping_pow_princess 01/18/15 02:49:06 PM
#6404   Do you have a web link or more info? andy55q 01/18/15 10:26:40 AM
#6403   Distributor in Italy? andy55q 01/18/15 09:38:01 AM
#6402   Efficacy study of CytoSorb hemoperfusion device on IL-6 SABAI 01/18/15 03:43:01 AM
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