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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: CytoSorbents Appoints Dr. Joerg Scheier as European Medical Director 04/27/2015 09:00:00 AM
CTSO News: CytoSorbents Issues Letter to Shareholders 04/24/2015 08:00:00 AM
CTSO News: Additional Proxy Soliciting Materials (definitive) (defa14a) 04/22/2015 05:09:48 PM
CTSO News: Proxy Statement (definitive) (def 14a) 04/22/2015 05:07:43 PM
CTSO News: CytoSorbents to Present at the 14th Annual Needham Healthcare Conference 04/14/2015 07:00:00 AM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#7040   Thank you for your comments. I came to ping_pow_princess 05/02/15 12:49:47 PM
#7039   Hey Ping Karlandang 05/02/15 11:18:33 AM
#7038   I see, it shows no affect in that Believed 05/02/15 01:55:47 AM
#7037   Summary of the Biocon Deal ping_pow_princess 05/02/15 01:19:25 AM
#7036   They are not experimenting with smaller beads. They ping_pow_princess 05/02/15 12:40:46 AM
#7035   So far the numbers are this: 50 hospitals ping_pow_princess 05/02/15 12:33:20 AM
#7034   I THINK that's probably the reason why they Believed 05/02/15 12:08:25 AM
#7033   Great post Ping. Cytosorb showed no benefit Believed 05/01/15 11:49:59 PM
#7032   Innovationen aus der Medizin: Der Stabilisator ping_pow_princess 05/01/15 05:44:35 PM
#7031   If you work for a bank you sure Paulness 05/01/15 03:48:49 PM
#7030   I disagree with both of you but time BuyMyAsk 05/01/15 09:36:50 AM
#7029   We may assume, that the CTSO filters may caesare74 05/01/15 07:05:13 AM
#7028   Clinical impact of stress dose steroids in patients andy55q 05/01/15 06:53:22 AM
#7027   The last two years has been a learning Believed 05/01/15 01:34:48 AM
#7026   BMA, every has a different way of looking Believed 05/01/15 01:26:32 AM
#7025   Technical Specialists- What's your current read for bkmomail 04/30/15 05:35:46 PM
#7024   Investment bank, not really. I have a banker's caesare74 04/30/15 04:50:17 PM
#7023   Agree to disagree. You are starting to BuyMyAsk 04/30/15 02:33:16 PM
#7022   EU is a very good reference for the caesare74 04/30/15 11:58:09 AM
#7021   The product hasn't sold in the last 1-2 BuyMyAsk 04/30/15 11:44:50 AM
#7020   Hi Andy, many thanks again from my side caesare74 04/30/15 11:00:07 AM
#7019   Glad I convinced you to sell and you BuyMyAsk 04/30/15 09:15:59 AM
#7018   It is great that you believe that, however, BuyMyAsk 04/30/15 09:14:05 AM
#7017   Dude its 9 months.. Q1 2014 to Q2 BuyMyAsk 04/30/15 09:12:46 AM
#7016   Cytosorbents Corporation (CTSO) -NasdaqCM ? Watchlist snow 04/30/15 09:02:50 AM
#7015   You state that "Thus, I have a harder ping_pow_princess 04/29/15 09:43:15 PM
#7014   https://www.facebook.com/cytosorbents andy55q 04/29/15 05:55:19 PM
#7013   snow, that is incorrect. Revenue lowered 4qrt Believed 04/29/15 04:26:14 PM
#7012   "We knew about the case, which is also andy55q 04/29/15 01:55:12 PM
#7011   CytoSorb on German TV andy55q 04/29/15 01:49:34 PM
#7010   Herpes viruses can cause blood poisoning ping_pow_princess 04/29/15 11:37:01 AM
#7009   EAP: the new FDA super weapon andy55q 04/29/15 08:39:21 AM
#7008   Believed Revenues have already been more or less flat snow 04/29/15 02:56:08 AM
#7007   caesare74 This stock has already taken off. The market snow 04/29/15 02:53:17 AM
#7006   caesare74 I have monitored this company for several years snow 04/29/15 02:48:43 AM
#7005   BuyMyAsk I read a lot of your posts last snow 04/29/15 02:35:45 AM
#7004   BMA, I read that there are group studies Believed 04/29/15 12:30:13 AM
#7003   I totally agree with Caesare74 on this one. Believed 04/29/15 12:09:57 AM
#7002   BMA, according to DR. Chan, revenue will be Believed 04/29/15 12:01:27 AM
#7001   Many thanks Andy. As my mother language is caesare74 04/28/15 04:38:46 PM
#7000   I would appreciate that. TY! BuyMyAsk 04/28/15 02:39:02 PM
#6999   Let me take your question back to a caesare74 04/28/15 02:35:41 PM
#6998   Your statement does not account for the fact BuyMyAsk 04/28/15 02:32:12 PM
#6997   I'm with you that the stocks market corrected caesare74 04/28/15 02:27:49 PM
#6996   caesare74 - I dont want to sound condescending BuyMyAsk 04/28/15 01:52:04 PM
#6995   We are going there. See, CTSO is a caesare74 04/28/15 01:44:05 PM
#6994   I really do not think I am bashing BuyMyAsk 04/28/15 01:20:12 PM
#6993   I bought on EAP information because after reading BuyMyAsk 04/28/15 01:14:27 PM
#6992   IMO, BMA is a believer in CTSO, except Believed 04/28/15 01:05:02 PM
#6991   caesare The objective side is achieved sales is it not? snow 04/28/15 12:34:36 PM
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