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Cytosorbents Corporation (CTSO)

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Last Post: 4/24/2014 11:12:24 AM - Followers: 167 - Board type: Free - Posts Today: 1
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 Present at the 13th Annual Needham Healthcare Conference 04/03/2014 08:30:00 AM
CTSO News: CytoSorbents Posts Record Q4 2013 and Full Year 2013 Revenue 03/31/2014 04:05:00 PM
CTSO News: CytoSorbents to Report Fiscal 2013 Operating and Financial Results 03/25/2014 07:00:00 AM
CTSO News: CytoSorbents to Sponsor CytoSorb® Research Symposium at ISICEM 2014 03/13/2014 06:00:00 AM
CTSO News: CytoSorbents Corporation Announces $10,200,000 Registered Direct Offering 03/07/2014 09:31:00 AM
PostSubject
#4897  Sticky Note NEWS: CytoSorbents Posts Record Q4 2013 -2- DJNFThis James Russler 04/01/14 09:05:22 AM
#4699  Sticky Note CTSO Arbel 03/09/14 11:57:05 AM
#5076   I joined up with 40k. It looks like TheDane 04/24/14 11:12:24 AM
#5075   Yes interesting "break" for companies like CTSO... The_Free_Nebula 04/22/14 02:09:54 PM
#5074   FDA NEWS RELEASE andy55q 04/22/14 02:07:58 PM
#5073   FDA proposes new expedited access program for medical Paulness 04/22/14 01:46:14 PM
#5072   Nice to see this move in the green The_Free_Nebula 04/22/14 01:26:43 PM
#5071   Nice volume today , accumulate. Paulness 04/21/14 03:51:51 PM
#5070   My model is showing a 30 to 1 BuyMyAsk 04/21/14 02:24:07 PM
#5069   Nice - those are impressive buys and sells. BuyMyAsk 04/21/14 10:21:19 AM
#5068   I agree this shouldn't uplist until there is eColi 04/21/14 10:07:05 AM
#5066   I am truly baffled by your response. BuyMyAsk 04/17/14 02:25:48 PM
#5065   Snow - thank you for understanding where I BuyMyAsk 04/17/14 02:21:09 PM
#5064   Sabai I totally disagree. I often write negative things snow 04/17/14 01:49:30 PM
#5063   Im not a novice, like you are neither SABAI 04/17/14 01:00:48 PM
#5062   SABI - are you a novice in the BuyMyAsk 04/17/14 12:42:44 PM
#5061   "These 5 things are very bad For CTSO" SABAI 04/17/14 11:13:54 AM
#5060   For arguments sake. BuyMyAsk 04/17/14 09:41:38 AM
#5059   Regulatory Mandates for Sepsis Care — Reasons for Caution andy55q 04/17/14 07:39:50 AM
#5058   ping I just listened to the presentation by Chan snow 04/17/14 05:38:24 AM
#5057   ICU-Acquired Weakness and Recovery from Critical Illness andy55q 04/16/14 07:06:19 PM
#5056   Ping - this is what I thought. BuyMyAsk 04/15/14 01:38:01 PM
#5055   The 'Intended Use Statement' is a driver in Plowmaster 04/15/14 11:45:01 AM
#5054   The company has publicly stated that they plan ping_pow_princess 04/15/14 11:25:51 AM
#5053   Plowmaster I appreciate your input. Does the BuyMyAsk 04/15/14 10:50:59 AM
#5052   Sorry i can only post 3 times a Plowmaster 04/15/14 10:18:28 AM
#5051   Chris there is no legitamate analyst coverage for BuyMyAsk 04/15/14 09:17:56 AM
#5050   Do you know of any analyst coverage for chrisgold 04/15/14 07:13:29 AM
#5049   Thanks for the explanation of the diffrent process. PJO 04/14/14 06:41:18 PM
#5048   Dr.L - do you think this is a BuyMyAsk 04/14/14 01:32:37 PM
#5047   Yes your credentials certainly do boost your opinion. BuyMyAsk 04/14/14 01:07:34 PM
#5046   Just my opinion, but it should be a Plowmaster 04/14/14 01:03:02 PM
#5045   I agree. The upside potential is HUGE! Cheers! crookedneck 04/14/14 11:55:39 AM
#5044   Is a PMA route out of the question BuyMyAsk 04/14/14 11:36:21 AM
#5043   Although it might take 9-12+ months for FDA Plowmaster 04/14/14 11:08:09 AM
#5042   Historical Share Count BuyMyAsk 04/14/14 10:56:33 AM
#5041   The FDA absolutely does not validate your clinical Plowmaster 04/14/14 10:29:01 AM
#5040   FDA approval is a stamp of quality and BuyMyAsk 04/14/14 09:13:23 AM
#5039   If anyone is interested in buying Cytosorbents stock Paulness 04/13/14 08:51:00 PM
#5038   Good point when you want to compare chrisgold 04/13/14 03:26:59 PM
#5037   chris Why do you attach so much importance to snow 04/13/14 02:05:52 PM
#5036   Ctso definitely seems to have theft entail and chrisgold 04/12/14 09:24:15 PM
#5035   If ctso can run the us trial with chrisgold 04/12/14 04:49:00 PM
#5034   New to CTSO? How did you find it? andy55q 04/11/14 09:23:36 PM
#5033   Thanks for posting the info from FDA web PJO 04/11/14 08:19:49 PM
#5031   Not an analyst or expert but ctso seems chrisgold 04/11/14 03:09:58 PM
#5030   Thanks for the follow-up. Being on FDA AKAPAK 04/11/14 01:27:12 PM
#5029   What do you mean? I don't think BuyMyAsk 04/11/14 01:06:21 PM
#5028   But this verifies what has been said on andy55q 04/11/14 01:00:40 PM
#5027   New on the FDA website but old news BuyMyAsk 04/11/14 10:59:03 AM
#5026   New on FDA web site: andy55q 04/11/14 10:54:56 AM
#5025   Let me know what you guys think of BuyMyAsk 04/11/14 10:23:40 AM
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