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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 News: CytoSorbents to Report Q1 2016 Operating and Financial Results 07:00 AM
CTSO News: Additional Proxy Soliciting Materials (definitive) (defa14a) 04/25/2016 01:27:13 PM
CTSO News: Proxy Statement (definitive) (def 14a) 04/25/2016 01:25:16 PM
CTSO News: CytoSorbents To Present At The 15th Annual Needham Healthcare Conference 04/06/2016 08:45:00 AM
CTSO News: Current Report Filing (8-k) 04/05/2016 11:21:15 AM
News News Alert: CytoSorbents to Report Q1 2016 Operating and Financial Results 05/02/2016 07:00:00 AM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#7595   NEWS -- CytoSorbents to Report Q1 2016 Operating Paulness 05/02/16 08:36:12 AM
#7594   FROM YAHOO MB andy55q 04/30/16 02:18:16 PM
#7593   A Targeted Agent to Mitigate Sepsis andy55q 04/28/16 09:49:06 PM
#7592   JPEO-CBD Awards Contract for Weaponized Toxin Treatments andy55q 04/28/16 09:32:52 PM
#7591   Army Testing CytoSorbents Cytokine Filters for Biodefense andy55q 04/28/16 09:16:56 PM
#7590   News on INTENSIVMED LLC, Web Site andy55q 04/28/16 03:20:23 PM
#7589   ?2015 ANNUAL REPORT7 ANNUAL REPORT : A Leader vinovista 04/28/16 12:23:56 PM
#7588   International Collaboration Brings New Sepsis Treatment to Italy andy55q 04/17/16 04:46:15 PM
#7587   New tender bid for Cytosorb from Italy andy55q 04/17/16 04:44:56 PM
#7586   First report of cytokine removal using CytoSorb® in andy55q 04/16/16 09:42:22 AM
#7585   We Need To Change The Way We Deal andy55q 04/16/16 09:37:22 AM
#7584   Cappuccino with Claudio Ronco: 95. Sepsis and AKI: andy55q 04/15/16 07:03:29 AM
#7583   Im loaded til under the roof...Multi Billion $$$ SABAI 04/07/16 01:22:00 PM
#7582   This thing is getting handier than duct tape. Murph1953 04/07/16 01:43:53 AM
#7581   2016 ACMT Annual Scientific Meeting andy55q 04/06/16 03:05:36 PM
#7580   http://www.acmt.net/_Library/2016_Annual_Scientific_Meeting/Platform_5.pdf Didn Babykahn 04/06/16 11:45:31 AM
#7579   NEWS -- CytoSorbents To Present At The 15th Paulness 04/06/16 08:54:15 AM
#7578   Case of the week 13/2016 andy55q 04/06/16 06:56:38 AM
#7577   Cytokine Reduction in the Setting of an ARDS-Associated andy55q 04/02/16 03:46:42 PM
#7576   RECCAS - REmoval of Cytokines during CArdiac Surgery: andy55q 04/02/16 03:45:29 PM
#7575   This company should be burning hot The_Free_Nebula 04/01/16 03:58:51 PM
#7574   FDA Grants Vical Fast Track Designation for VL-2397 andy55q 03/30/16 09:28:23 AM
#7573   Patty Duke’s Death Announcement Is A Milestone For andy55q 03/30/16 09:26:03 AM
#7572   The Netherlands Journal of Critical Care (NJCC) andy55q 03/30/16 07:22:06 AM
#7571   Case of the week #12/2016 andy55q 03/30/16 07:05:12 AM
#7570   NEWS -- CytoSorbents Awarded $150,000 Phase I SBIR Paulness 03/25/16 09:17:44 AM
#7569   Case of the week #11/2016 andy55q 03/23/16 07:31:33 AM
#7568   Good candidate for CS filter, good PR for CTSO Murph1953 03/19/16 01:11:14 AM
#7567   Some may find this interesting - informative and explanatory. Murph1953 03/18/16 01:37:20 AM
#7566   We are getting action...fasten your seatbelt ! I SABAI 03/17/16 04:35:02 PM
#7565   THIS IS IT...THE START..ALL IMO. GLA SABAI 03/17/16 03:55:26 PM
#7564   NEWS -- Cytosorb Study: PAMPs and DAMPs Removed Paulness 03/17/16 08:12:33 AM
#7563   Case study #10 2016 andy55q 03/17/16 06:49:19 AM
#7562   Paulness, thanks...Oh, goodie, "..a more detailed report of Murph1953 03/16/16 11:22:30 AM
#7561   When is "10/2016"? Murph1953 03/16/16 11:18:23 AM
#7560   NEWS -- CytoSorbents Reports on Successful 3rd International Paulness 03/16/16 08:56:38 AM
#7559   Case of the week 10/2016 andy55q 03/16/16 06:56:26 AM
#7558   I like this.. Murph1953 03/15/16 09:54:25 PM
#7557   andy55q, It's been 7 1/2 Months ("German Clinical Trials Murph1953 03/15/16 09:50:08 PM
#7556   RECCAS - REmoval of Cytokines during CArdiac Surgery: andy55q 03/15/16 08:49:08 AM
#7555   Brean Capital analyst Has $24.00 andy55q 03/14/16 10:29:26 AM
#7554   NEWS -- CytoSorbents to Host 3rd International CytoSorb® Paulness 03/14/16 09:01:13 AM
#7553   105 3rd International CytoSorb Users’ meeting andy55q 03/13/16 10:49:01 PM
#7552   Sepsis Definition Update andy55q 03/13/16 10:35:46 AM
#7551   In 2016 Fresenius and other nations will be Murph1953 03/12/16 01:20:01 PM
#7550   need to find a way to sustain upward momo The_Free_Nebula 03/11/16 01:48:33 PM
#7549   CEO: Wrack your brain Murph1953 03/11/16 01:34:09 PM
#7548   Sales continue to disappoint. They need to grow greenaccountingbeen 03/10/16 12:39:54 PM
#7547   102 PARTICIPANTS 3rd International CytoSorb Users’ meeting andy55q 03/10/16 11:07:12 AM
#7546   Cytosorbents Corp (CTSO) Rating Reiterated by Brean Capital dah174174 03/10/16 10:09:55 AM
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