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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 News: Statement of Changes in Beneficial Ownership (4) 07/24/2014 05:10:22 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 07/24/2014 05:08:55 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 07/24/2014 05:07:09 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 07/24/2014 05:05:55 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 07/24/2014 05:04:17 PM
PostSubject
#5502   Distributor in Slovenia, Medis Zdrave Vrednote. ping_pow_princess 07/25/14 12:02:20 PM
#5501   Same director as before Al Kraus no one stockmule 07/25/14 09:52:43 AM
#5500   I would love to have some of their options. moemr2 07/24/14 06:05:10 PM
#5499   Major insiders buying registrations today!!.Something is going to Paulness 07/24/14 06:01:16 PM
#5498   A lot of form 4's today.. moemr2 07/24/14 05:49:24 PM
#5497   Makenlight roughly speaking how big is that pond? Murph1953 07/24/14 01:36:06 PM
#5496   Evaluation of an experimental filter designed for improving Makenlight 07/24/14 04:35:54 AM
#5495   Inflammatory Disorder of the Brain andy55q 07/23/14 10:20:31 PM
#5494   CytoSorb patient registry: ping_pow_princess 07/23/14 01:20:19 PM
#5493   For the past few years, the company exhibited ping_pow_princess 07/23/14 12:49:11 PM
#5492   Steroids Fail Another Test in Bypass Surgery - andy55q 07/22/14 01:18:24 PM
#5491   Biocon's Annual review and Annual report ping_pow_princess 07/22/14 09:55:41 AM
#5488   Cytosorbents has the ability to filter out interleukin-6 (IL-6) Paulness 07/20/14 09:29:01 PM
#5487   http://m.seekingalpha.com/article/2323205-cardiac-surgery-rapidly-evolving-as-su moemr2 07/19/14 02:26:15 PM
#5486   New seeking alpha article out! moemr2 07/19/14 02:25:06 PM
#5485   Interleukin 6 promotes endometrial cancer growth Makenlight 07/19/14 12:40:17 PM
#5484   ping_pow_princess-Yahoo Message Board-very good write up. andy55q 07/18/14 07:31:50 AM
#5481   Murph - I understand what you are saying. BuyMyAsk 07/17/14 01:44:36 PM
#5480   BMA from my prior post Murph1953 07/17/14 12:48:35 PM
#5478   Few things to discuss... BuyMyAsk 07/17/14 09:10:03 AM
#5477   Response EMAIL FROM DOCTOR CHAN regarding up-listing andy55q 07/17/14 07:58:58 AM
#5476   Thursday July 17, 2014 ( from co. website ) Murph1953 07/16/14 11:02:00 PM
#5475   Another conference for sepsis treatment, although a new presenter andy55q 07/16/14 05:41:17 PM
#5474   I know what you mean , can't they Paulness 07/15/14 12:36:23 PM
#5473   So Al Kraus is selling now everyday 50K SABAI 07/15/14 12:07:32 PM
#5472   ABC introduced a novel extra corporeal therapy (CytoSorb) andy55q 07/15/14 09:27:00 AM
#5471   It's from 2011. Good video. andy55q 07/14/14 07:41:55 PM
#5470   Three week old video Cytosorbents , it is Paulness 07/14/14 06:10:21 PM
#5469   New Youtube Video Paulness 07/14/14 06:01:56 PM
#5467   Dr. John Kellum, Dr. Peng, and our scientific andy55q 07/10/14 04:18:36 PM
#5466   Everything listed are what they have done and ping_pow_princess 07/10/14 04:07:30 PM
#5465   Ping - your review is so buy side BuyMyAsk 07/10/14 03:51:56 PM
#5464   From CTSO Facebook andy55q 07/10/14 02:22:44 PM
#5463   Great review, thank you ping_pow. WishfulThinking1 07/10/14 12:35:39 PM
#5462   Half-year Review and forward ping_pow_princess 07/09/14 11:37:17 PM
#5461   BMA i agree with ur view and that chrisgold 07/09/14 07:08:06 PM
#5460   Moon shot for CTSO today? JenPompano 07/09/14 04:30:00 PM
#5459   Why is Al Kraus selling 4 times 50K SABAI 07/09/14 03:38:22 PM
#5458   I agree Chris. FDA approval for this BuyMyAsk 07/09/14 11:34:43 AM
#5457   CytoSorbents Consolidates SEC and International Legal Counsel with andy55q 07/09/14 08:43:30 AM
#5456   BMA and PROUDAMERICAN can you answer ......low success chrisgold 07/08/14 05:54:04 PM
#5455   As you can see from the links chrisgold 07/08/14 02:59:52 PM
#5454   Scientific and clinical challenges in sepsis. andy55q 07/08/14 10:08:16 AM
#5453   Why have clinical trials in sepsis failed? andy55q 07/08/14 10:06:38 AM
#5452   BMA have seen lot of ur posts very chrisgold 07/08/14 09:51:48 AM
#5451   You got that right...LOL! The dude wanted The_Free_Nebula 07/05/14 09:35:32 AM
#5450   Needed and or wanted some money so he The_Free_Nebula 07/05/14 09:34:10 AM
#5449   interesting but undated material... The_Free_Nebula 07/05/14 09:32:12 AM
#5448   Modulation of chemokine gradients by apheresis redirects leukocyte andy55q 07/04/14 10:36:22 AM
#5447   Nice article thanks for sharing it bustingmyask 07/04/14 08:08:00 AM
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