SureTrader SPDR Advertisement
Home > Boards > US Listed > Medical - Equipment >

Cytosorbents Corporation (CTSO)

CTSO RSS Feed
Add CTSO Price Alert      Hide Sticky   Hide Intro
Moderator: No Moderator The_Free_Nebula, BuyMyAsk, eColi
Search This Board:
Last Post: 8/27/2015 3:43:30 PM - Followers: 178 - Board type: Free - Posts Today: 0
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


  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
  • 2Y
  • 3Y
  • 5Y
CTSO
Current Price
Volume:
Bid Ask Day's Range
Wiki
CTSO News: Statement of Changes in Beneficial Ownership (4) 08/24/2015 01:22:47 PM
CTSO News: Statement of Changes in Beneficial Ownership (4) 08/17/2015 11:35:09 AM
CTSO News: Current Report Filing (8-k) 08/14/2015 06:03:54 AM
CTSO News: Quarterly Report (10-q) 08/13/2015 05:42:40 PM
CTSO News: CytoSorbents Reports Steady Growth in Q2 2015 08/13/2015 04:15:00 PM
PostSubject
#6174  Sticky Note From Yahoo MB-Updated Cytosorbents Overview andy55q 12/19/14 10:40:16 AM
#7308   16th International Symposium on Albumin Dialysis in Liver Disease andy55q 08/27/15 03:43:30 PM
#7307   2nd International CytoSorb User Meeting andy55q 08/27/15 08:00:16 AM
#7306   57 PARTICIPATING CLINICAL CENTERS- Cytosorb Registry andy55q 08/26/15 10:28:01 AM
#7305   Here's another: andy55q 08/21/15 08:24:10 AM
#7304   News from Germany: http://us10.campaign-archive1.com/?u=c156903f332989484c9065f bkmomail 08/21/15 07:09:07 AM
#7303   http://www.lulegacy.com/2015/08/19/insider-selling-cytosorbents-corp-director-sells-62600-00-in-stoc eColi 08/20/15 10:26:12 AM
#7302   No, like I said - there is any rule_rationale 08/20/15 09:44:36 AM
#7301   SABAI - the recent movement in stock price, BuyMyAsk 08/20/15 09:25:15 AM
#7300   Yes I agree with you but in hindsight BuyMyAsk 08/20/15 09:22:31 AM
#7299   New imports India (biggest yet) andy55q 08/20/15 08:35:24 AM
#7298   New high of the year in September/Oktober. Wanna SABAI 08/19/15 04:20:18 PM
#7297   Take the Time to read the Transcript!! andy55q 08/19/15 03:39:09 PM
#7296   Its not negative, its life. SABAI 08/19/15 02:51:37 PM
#7295   Kind of what I was thinking. Didn't want rdgere 08/19/15 02:34:37 PM
#7294   He's an old man needing cash for personal SABAI 08/19/15 01:01:00 PM
#7293   It's interesting that Mr. Kraus is the ONLY rdgere 08/19/15 12:26:04 PM
#7292   Do we really need to go over this rule_rationale 08/19/15 11:05:00 AM
#7291   Kraus Sales BuyMyAsk 08/19/15 09:55:00 AM
#7290   http://www.smarteranalyst.com/2015/08/17/brean-capital-reiterates-buy-on-cytosor eColi 08/18/15 10:58:25 AM
#7289   http://www.octafinance.com/what-after-krauss-insider-sale-of-cytosorbents-corp-n eColi 08/18/15 10:51:20 AM
#7288   Yes it will - IMHO short sellers are BuyMyAsk 08/18/15 10:13:34 AM
#7287   Right on. But the EAP Approval will boost SABAI 08/18/15 09:02:30 AM
#7286   EAP approval is not the end game. BuyMyAsk 08/18/15 09:00:20 AM
#7285   im expecting FDA EAP Approval in September with SABAI 08/18/15 05:32:35 AM
#7284   Nice The_Free_Nebula 08/18/15 03:05:31 AM
#7283   The thing that is going on now is BuyMyAsk 08/17/15 02:09:12 PM
#7282   Dah - you must be a child to BuyMyAsk 08/17/15 01:30:21 PM
#7281   It actually is a pretty good contrarian indicator rule_rationale 08/17/15 11:01:38 AM
#7280   He's more like "Talking Out His Ask" andy55q 08/17/15 10:59:43 AM
#7279   WHY DO YOU KEEP POSTING. YOU SAY YOU dah174174 08/17/15 10:33:18 AM
#7278   The chances of this product getting FDA approval BuyMyAsk 08/17/15 09:28:31 AM
#7277   FDA in our conversations with them have said andy55q 08/15/15 07:30:28 AM
#7276   The exchange rate is a valid issue. lexusandolive 08/14/15 01:01:13 PM
#7275   Coming in 3rd quarter/Near term? eColi 08/14/15 10:00:50 AM
#7274   Seems like there are plenty of reasons to eColi 08/14/15 09:58:18 AM
#7273   The exchange rate is a valid issue. lexusandolive 08/14/15 09:57:56 AM
#7272   Bought 3K Shares at 7.05. Just for fun. Lol SABAI 08/14/15 09:49:31 AM
#7271   The only justification for the price increasing is BuyMyAsk 08/14/15 09:17:35 AM
#7270   Strongly agree. Glad you finally came around BuyMyAsk 08/14/15 09:06:21 AM
#7269   true, but you dont base the success of SABAI 08/14/15 07:30:38 AM
#7268   Disregarding the decline in the Euro to U.S. andy55q 08/14/15 07:18:24 AM
#7267   Q2 2015 Earnings Call Transcript: CytoSorbents Corporation bkmomail 08/14/15 06:36:22 AM
#7266   Great. But 773K in product sales isnt really encouraging.... SABAI 08/14/15 12:57:28 AM
#7265   They doubled their cash and revenue - I'll rule_rationale 08/13/15 07:44:23 PM
#7264   another sad quarter for CTSO. Maybe some day dr_lowenstein 08/13/15 07:26:59 PM
#7263   UP 10% IN AFTERMARKET $6.80 LAST SALE dah174174 08/13/15 06:19:17 PM
#7262   Very positive conference call. Video on the transplant dah174174 08/13/15 06:06:14 PM
#7261   "CytoSorbents has not historically given financial guidance on BuyMyAsk 08/13/15 04:56:37 PM
#7260   http://seekingalpha.com/pr/14409706-cytosorbents-reports-steady-growth-in-q2-201 greenaccountingbeen 08/13/15 04:38:12 PM
#7259   New distributors andy55q 08/11/15 10:34:53 AM
PostSubject