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Last Post: 12/8/2016 4:17:21 PM - Followers: 174 - Board type: Free - Posts Today: 7
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) 12/07/2016 05:26:37 PM
CTSO News: CytoSorb® Attains Permanent, Dedicated Reimbursement Code in Core Market of Germany 12/07/2016 07:00:00 AM
CTSO News: CytoSorbents to Present at the LD Micro Main Event Investor Conference 12/02/2016 08:00:00 AM
CTSO News: CytoSorb® Selected for NICE MedTech Innovation Briefing in the United Kingdom 12/01/2016 07:15:00 AM
CTSO News: First Successful Treatment of Dengue Fever and Dengue Shock Syndrome Using CytoSorb® 11/22/2016 08:20:00 AM
PostSubject
#7791   Hopefully there will be REFRESH 1 data available orangecat 12/08/16 04:17:20 PM
#7790   The link to the webcast is in the orangecat 12/08/16 02:44:20 PM
#7789   Is the webcast still available? clints 12/08/16 12:25:16 PM
#7788   One more thing that caught my ear.Dr.Chan said berthabluefish1 12/08/16 11:52:09 AM
#7787   Thanks bertha! clints 12/08/16 11:33:17 AM
#7786   Dr. Chan said Terumo's first order for Cytosorb berthabluefish1 12/08/16 10:37:52 AM
#7785   According to Cytosorbents Corporation's most recent Form 4 IL-6 12/08/16 07:44:15 AM
#7784   I'm not sure how it really works. Psuforlife 12/07/16 09:45:43 PM
#7783   The most important thing to me on this Gman214 12/07/16 08:56:50 PM
#7782   Agree, this is a big deal techxen 12/07/16 06:48:48 PM
#7781   I think this board is easier to use. Psuforlife 12/07/16 06:32:04 PM
#7780   Q1 2017 finally the start of inflection point, clints 12/07/16 04:37:39 PM
#7779   Case of the week 48/2016 andy55q 12/07/16 12:40:25 PM
#7778   Thanks Guys!It will be interesting to hear what berthabluefish1 12/07/16 11:31:17 AM
#7777   It certainly is good news. We needed it. Gman214 12/07/16 11:14:30 AM
#7776   This is expected to Catalyze Increases in Adoption berthabluefish1 12/07/16 09:42:17 AM
#7775   Awesome news guys!!!! It's huge! Psuforlife 12/07/16 09:26:13 AM
#7774   NEWS -- CytoSorb® Attains Permanent, Dedicated Reimbursement Code Paulness 12/07/16 09:19:53 AM
#7773   Welcome to the big boys board Bertha. Nice dah174174 12/07/16 09:06:19 AM
#7772   This is really powerful news. CTSO presents tonight dah174174 12/07/16 09:03:53 AM
#7771   Sure is Andy.Looks like we are on way berthabluefish1 12/07/16 08:47:20 AM
#7770   GOOD NEWS TODAY!! andy55q 12/07/16 08:19:19 AM
#7769   Immune System, Unleashed by Cancer Therapies, Can Attack Organs aculeus 12/04/16 12:27:40 PM
#7768   Hybrid blood purification strategy in pediatric septic shock andy55q 12/04/16 12:17:35 PM
#7767   Pediatric septic shock techxen 12/04/16 10:54:07 AM
#7766   Thanks Tech Psuforlife 12/04/16 09:57:28 AM
#7765   Google Scholar http://downloads.hindawi.com/journals/cricc/aip/6987167.pdf techxen 12/03/16 06:36:25 PM
#7764   Hey tech where did you find this? Was Psuforlife 12/03/16 04:09:06 PM
#7763   Hemoadsorption with CytoSorb - Pediatric Case techxen 12/03/16 10:02:44 AM
#7762   NEWS -- CytoSorbents to Present at the LD Paulness 12/02/16 09:29:42 AM
#7761   NEWS -- CytoSorb® Selected for NICE MedTech Innovation Paulness 12/01/16 09:07:50 AM
#7760   CytoSorbents announces the publication of a MedTech Innovation dah174174 12/01/16 08:09:36 AM
#7759   Case of the week 47/2016 andy55q 11/30/16 06:47:01 AM
#7758   Immunotherapy Encompasses More Than Immuno-oncology andy55q 11/28/16 12:23:58 PM
#7757   3rd CytoSorb Users’ Meeting D-A-CH 2016 andy55q 11/25/16 06:23:14 PM
#7756   What happen to BuyMyAsk? andy55q 11/23/16 10:04:46 AM
#7755   Case of the week 46/2016 andy55q 11/23/16 07:02:42 AM
#7754   First Successful Treatment of Dengue Fever and Dengue andy55q 11/22/16 08:42:21 AM
#7753   CytoSorbents Reports Highlights from the SepsEast 2016 Critical andy55q 11/17/16 08:53:29 AM
#7752   A CLINICAL EXPERIENCE OF USING EXTRACORPOREAL CYTOKINE ADSORPTION andy55q 11/16/16 08:54:35 AM
#7751   Case of the week 45/2016 andy55q 11/16/16 08:22:17 AM
#7750   NEWS -- Adrian Thomas Joins CytoSorbents to Drive Paulness 11/15/16 09:24:28 AM
#7749   SepsEast 2016 andy55q 11/10/16 09:42:48 AM
#7748   Case of the week 44/2016 andy55q 11/10/16 09:06:46 AM
#7747   Take a look at KTOV, cheapest and got LearnToTrade 11/09/16 11:35:21 PM
#7746   cars My girl friend is invested in this company snow 11/09/16 02:26:32 PM
#7745   Snow, maybe you should move on. CTSO's chart cars100cars 11/09/16 08:12:33 AM
#7744   To me it is hardly good news that snow 11/09/16 03:13:31 AM
#7743   Q316 growth outstanding! Revenue was $2.4 million, a cars100cars 11/08/16 02:45:17 PM
#7742   Let me correct your selective context: rule_rationale 11/08/16 11:11:21 AM
PostSubject