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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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CTSO News: CytoSorbents Wins Beacon of Light Award 11/21/2014 09:00:00 AM
CTSO News: Statement of Changes in Beneficial Ownership (4) 11/19/2014 10:11:01 AM
CTSO News: Current Report Filing (8-k) 11/17/2014 06:05:53 AM
CTSO News: Current Report Filing (8-k) 11/14/2014 09:06:04 AM
CTSO News: CytoSorbents Announces Appointment of New Board Director 11/14/2014 09:00:00 AM
PostSubject
#6009   It's true that reverse stock splits usually result laker5 11/23/14 03:22:39 PM
#6008   Thanks Believed Nice post . Paulness 11/23/14 01:18:08 PM
#6007   Paulness, I have read many of you postings Believed 11/23/14 12:54:30 AM
#6006   Biocon the Pfizer of India, this partnership which Paulness 11/22/14 07:07:13 PM
#6004   Lots of people here sold, thinking price will Believed 11/21/14 10:44:37 PM
#6003   See what happens when you live in a Paulness 11/21/14 08:35:37 PM
#6002   Congrats longs on your Beacon of Light Award!!!! laker5 11/21/14 07:19:47 PM
#6001   7 studies found for: CytoSorb andy55q 11/21/14 06:12:15 PM
#6000   New Study on ClinicalTrials.gov processed this record on andy55q 11/21/14 06:10:35 PM
#5999   NEWS -- CytoSorbents Wins Beacon of Light Award Paulness 11/21/14 09:11:57 AM
#5998   Masterclass Satellite Symposium (Cytosorb ): Fix the leaky andy55q 11/20/14 09:26:51 PM
#5997   Life Sciences Report - George Zavoico of MLV dah174174 11/20/14 08:44:15 AM
#5996   This stock reminds me of a stock I J G R 11/19/14 03:39:08 PM
#5995   NEW ZACHS UPDATE - CTSO HIGHLY UNDERVALUED dah174174 11/18/14 11:17:01 AM
#5994   First Use of a Hemoadsorption Device (Cytosorb®) During andy55q 11/17/14 09:22:21 PM
#5993   The Effect of Early Cytokine Absorption on the andy55q 11/17/14 07:04:22 PM
#5992   Watch Live: Doctors Discuss the Death of Ebola andy55q 11/17/14 11:19:57 AM
#5991   From the conference call! Paulness 11/17/14 10:41:06 AM
#5990   The 25:1 is to get them to a The_Free_Nebula 11/17/14 06:39:43 AM
#5989   What are your reasons for voting FOR or bkmomail 11/16/14 08:04:22 PM
#5988   I can't find the control number and I Ace up my sleeve 11/16/14 05:02:38 PM
#5987   I was led to believe that Cyrus orb Glimmer Man 11/16/14 12:46:17 AM
#5986   If only Cytosorbents could make Press releases like Paulness 11/14/14 04:33:05 PM
#5985   Blood-Filtering Ebola Device Ready for Testing andy55q 11/14/14 10:09:56 AM
#5984   6 studies found for: CytoSorb andy55q 11/14/14 08:08:50 AM
#5983   The systemic immune response to trauma: an overview andy55q 11/14/14 08:03:33 AM
#5982   I know CT SO is being manipulated. Damn Glimmer Man 11/14/14 02:28:10 AM
#5981   I've heard of 10 to 1 reverses but Glimmer Man 11/14/14 02:25:31 AM
#5980   I love the future prospects of Cytosorbents Paulness 11/13/14 05:19:47 PM
#5978   New on ClinicalTrials.gov andy55q 11/13/14 11:41:25 AM
#5977   CytoSorbents Press Release bkmomail 11/13/14 11:29:39 AM
#5976   Severe Sepsis and Septic Shock andy55q 11/13/14 07:40:36 AM
#5975   Could this be related to Ebola treatments? Paulness 11/12/14 11:23:13 PM
#5974   Hi Ping, pharmeng 11/12/14 07:36:53 PM
#5973   Global threat to humanity Doctors around the world andy55q 11/12/14 07:14:09 PM
#5972   Happy to see that Biocon is showcasing Cytosorb andy55q 11/12/14 04:12:12 PM
#5971   The shares outstanding are reported in the SEC laker5 11/12/14 11:00:40 AM
#5969   Way off...not sure where you got your o/s The_Free_Nebula 11/12/14 02:29:19 AM
#5968   http://www.massdevice.com/news/cytosorbents-inks-deal-with-unnamed-cardiac-surge Believed 11/12/14 12:26:50 AM
#5967   Invitation to Masterclass Satellite Symposia on Nov 28th! andy55q 11/11/14 08:50:23 PM
#5966   CTSO selling product moreover quarter over quarter and Paulness 11/11/14 03:09:31 PM
#5964   CTIX will get listed to the big boards SABAI 11/11/14 04:54:57 AM
#5963   600 million shares out = CTSO market cap laker5 11/10/14 02:58:05 PM
#5962   The doctors in Germany have cardiac surgery studies ping_pow_princess 11/10/14 02:38:57 PM
#5961   Their market very large Murph1953 11/10/14 02:15:56 PM
#5960   "..working with this top-four world leader in cardiac surgery." Murph1953 11/10/14 01:59:46 PM
#5959   Sorin Group as partner? ping_pow_princess 11/10/14 10:47:14 AM
#5958   NEWS -- CytoSorbents Announces Initial Partnership with a Paulness 11/10/14 09:08:22 AM
#5957   Partnership in France! dah174174 11/10/14 08:34:53 AM
#5956   Think of it this way CTIX is your Paulness 11/08/14 12:16:47 PM
PostSubject