MedaSorb Technologies Corp. ( WKN: A0KEY3 / MSBT )

MedaSorb's Blockbuster Product Could be Commercialized This Year

Posted on: Thu, 04 Feb 2010 10:32:52 EST
http://www.tradingmarkets.com/...commercialized-this-year-753686.html

In a recent interview, MedaSorb Technology Corporation's (OTC:  MSBT)

Chief Executive Officer, Dr. Phillip Chan, said in a recent interview that if European trials for its flagship product CytoSorb™ in Germany prove as successful as expected, the Company could receive EU approval and begin commercialization late this year.

CytoSorb™ is a novel blood purification device designed to treat people afflicted with severe sepsis. Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza. This devastating syndrome is characterized by an overwhelming systemic response to infection, which can rapidly lead to organ dysfunction and ultimately death. Dr. Chan cited alarming statistics regarding sepsis.

"Over 1 million people are afflicted with severe sepsis in the U.S., 1.5 million are affected in Europe and an estimated 18 million are affected worldwide." To put the severity of the condition into perspective, Dr. Chan further stated that, "Despite the best care available, in the U.S., 1 in 3 patients die from severe sepsis which is more than the number of people that die of heart attacks or single form of cancer."

The U.S. and EU markets alone for MedaSorb's medical device treatment, CytoSorb™, are huge, representing between $5 billion to $7 billion, with limited competition. The only direct competitor with an approved product is Eli Lilly, which markets Xigris™. Interestingly, while Xigris™ has proven to be a good product, it has had limited adoption due to its high cost, efficacy rates, timing of use, and potentially dangerous side effects.

Interestingly, much of the organ failure and mortality in severe sepsis is caused by the massive production of cytokines by the immune system, which clinicians refer to as a "cytokine storm". CytoSorb™ is a cartridge used with standard dialysis equipment, that contain highly porous polymer beads designed to remove certain, harmful cytokines and treat this potentially fatal cytokine storm.

MedaSorb's novel approach is not only a technological marvel, but the device has a 3 year shelf life, and can not only save hospital's ICU resources, but has 3rd party reimbursement plans associated with its use.

The Company is currently conducting its European Sepsis Trial in Germany, which is the 3rd largest medical device market in the world. The trials randomized, controlled clinical trial are being conducted in 14 sites, using the CytoSorb™ device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Management pointed out that in recent weeks, recruitment has been accelerating. With the trials expected to end sometime later this year, if proven successful, MedaSorb will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. Thus, MedaSorb appears to be on the cusp of migrating from the R&D phase to the revenue generating stage.

During his discussion of MedaSorb's history, Dr. Chan relayed an insightful story. As a partner in the NJTC Venture Fund, Dr. Chan led the Company's Series B $5.25 million investment round. When it came time to name a successor to the outgoing President, Dr. Chan was elected to take over the Company. The Company raised $1.3M in late 2009 via warrant exercise by existing shareholders, including Dr.Chan, who is very excited about the MedaSorb's prospects and present cash position, citing that. "We presently have a comfortable cash cushion" and may seek non-dilutive financing down the road.

In addition to treating severe sepsis, Dr. Chan believes that the CytoSorb™ device could potentially be used to treat other diseases and conditions and that the Company will develop a pipeline of proof of concept opportunities, including potential licensing candidates for the treatment of H1N1.

Since many infections such as severe sepsis, various forms of influenza such as H1N1, are the cycling of a cytokine storm as a body immune response, the use of the CytoSorb™ device could prove very effective. Management also believes that CytoSorb™ could one day be used as first line of defense against biological warfare such as anthrax or bubonic plague, as a treatment of the infection or pathogen triggered cytokine storm.

According to Dr. Chan, MedaSorb is currently weighing its options of signing up a strategic partner for potential European marketing of CytoSorb™, and it is possible that if the Company does not go it alone, that a strategic partner would be signed.

Dr. Chan noted, "If our technology works the way we hope it does, then it has the potential to be a blockbuster product. That can impact the top and bottom lines of most strategic partners. We believe we have a product that has little competition, a big market with unmet needs, technology attractive to strategic partners, and a solid, profitable business model."

If MedaSorb meets its goals, it will not only be attractive to strategic partners, but to prospective shareholders as well.

MedaSorb at Biotech Showcase 2010 (Audio_& Slideshow-Presentation)

http://webcastingplayer.corporate-ir.net/player/...=&override=reg

 

http://www.medasorb.com/

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 biomedreports.com/articles/subscriber-only-content/27655-watchlist-alert-for-thursday.html

  Written by BioMedReports.Com // Thursday, 04 February 2010 06:44

This company will be receiving considerable more attention as they get closer to the commercialization of a product that is badly needed in the medical community.

“Over 1 million people are afflicted with severe sepsis in the U.S., 1.5 million are affected in Europe and an estimated 18 million are affected worldwide.” To put the severity of the condition into perspective, Dr. Phillip Chan further stated that, “Despite the best care available, in the U.S., 1 in 3 patients die from severe sepsis which is more than the number of people that die of heart attacks or single form of cancer.”

 

Medasorb Technologies (OTC:MSBT) Corporation, a development stage medical device company, focuses on developing and commercializing blood purification technologies that would remove middle molecular weight toxins from circulating blood and physiologic fluids.

BioMedReports will be issusing a special report on MSBT, including an interview with Dr. Chan within the next 24-48 hours.

Related Story: http://www.tradingmarkets.com/news/stock-alert/...is-year-753686.html

 

http://www.tradingmarkets.com/news/stock-alert/...is-year-753686.html

... Dr. Chan noted, "If our technology works the way we hope it does, then it has the potential to be a blockbuster product. That can impact the top and bottom lines of most strategic partners. We believe we have a product that has little competition, a big market with unmet needs, technology attractive to strategic partners, and a solid, profitable business model."

If MedaSorb meets its goals, it will not only be attractive to strategic partners, but to prospective shareholders as well.

 

Has MedaSorb found the Holy Grail which has eluded medicine for decades?

Written by M.E.Garza   
Friday, 05 February 2010 05:00
biomedreports.com/articles/most-popular/27800-has-medasorb-found-the-holy-grail-to-treat-severe-infections.html

Anna Nicole Smith clearly didn't think she needed medical attention for systemic sepsis syndrome, a lethal blood infection when she passed away at the Seminole Hard Rock Hotel and Casino resort in Hollywood, Florida.

Even as I write this report, legendary singer Etta James remains hospitalized in a Southern California as she recovers from sepsis, an infection, her manager said was caused by a urinary tract infection.  

And as we read headlines that toxic cleaners are believed to be an underlying factor in Jett Travolta’s (son of actor John Travolta) untimely death at the age of 16, his father and mother held a fundraiser just last night in Ocala Florida for a detoxification project for local firefighters, policemen and emergency workers who have been exposed to toxins.

Actress Britney Murphy's main cause of death was pneumonia but iron deficiency anaemia and 'multiple drug intoxication' were cited as contributing factors by the Los Angeles County coroner's office and although the medical report issued to the media didn't name sepsis directly, it was a likely contributor, according to doctors familiar with the report.

According to experts, severe sepsis is a life-threatening condition which can affect anyone, and most often develops in patients with pneumonia, trauma, surgery, burns or cancer. Over 18 million cases of severe sepsis occur each year – that’s equivalent to the entire population of Denmark, Finland, Ireland and Norway added together. In the U.S., it kills more people than either heart attacks, strokes or any single type of cancer.

The number of severe sepsis cases is grows at a rate of 1.5% per year, due mainly to the growing use of invasive procedures and increasing numbers of elderly and high-risk individuals such as cancer and HIV patients. Older people are at increased risk of sepsis as they are more prone to infections due to ageing, co-morbidities, use of invasive surgical techniques and other problems.

Yes, Sepsis is a major challenge in medicine and according to various publications, massive resources have been invested in developing and evaluating potential therapies,  and considerable effort has been undertaken to understand the systemic inflammation and multiple-system organ failure characteristics of severe sepsis.

Three years ago, I nearly died when my blood became infected after a severe bout with diverticulitis.  I suddenly fell very ill and ended up in the hospital for nearly three weeks as doctors fought, first to calm the severe infection that threatened to shut down my kidneys before carting me off to surgery.

The demands made on hospital staff by patients like me, with these types of infections, place a significant burden on healthcare resources and one medical publication says it accounts for 40% of total ICU expenditure.

When I showed some of those same doctors who had treated me images and descriptions of Medasorb Technologies’ (MSBT.OB) flagship Cytosorb therapeutic device, they just about all asked the same thing:

“Is this real?”

“We could really use something like this,” said others.

These days, the first-line treatment doctors rely on to try to eliminate the underlying infections with antibiotics. Indeed, I remember having six or eight different antibiotic drips going into a main line and my blood was being tested every few hours in an effort to monitor how my body was responding.
Depending on the patient’s clinical status, additional therapies are initiated, including drug therapy and supportive care, such as mechanical ventilation and kidney dialysis.

There has been considerable excitement recently amongst critical care clinicians who care for patients like me.  For the first time there are trials showing positive results involving new therapeutic interventions like Medasorb’s. I spoke to Phillip Chan, MD, PhD, the CEO of Chief Executive Officer of the company. Dr. Chan is a Board-certified internal medicine physician with a strong background in clinical medicine and research, having completed his residency at Harvard Medical School at the Beth Israel Deaconess Medical Center. Dr. Chan received his MD/PhD from Yale University School of Medicine and his BS in cell and molecular biology from Cornell.

BioMedReports: Can you tell us about your company?

DR.CHAN: Sure, well Medasorb Technologies Corporation is a publically traded clinical trial stage therapeutic device company working to save lives through blood purification, that’s essentially what we do. At Medasorb  we’ve developed a highly bio-compatible, porous, polymer bead purification technology that can remove things as small as drugs and toxins from blood and physiologic fluids. Right now we are currently conducting a 100 patient, randomize controlled clinical trial in Europe with our flagship product CytoSorb to treat patients with severe sepsis which is often called “overwhelming infection”.

CytoSorb is a highly efficient cytokine filter designed to treat severe sepsis by reducing potentially deadly cytokine-storm which is a well known major cause of organ failure and mortality with this disease. We’re currently driving to complete our European sepsis trial and with a hopeful positive outcome, plan to obtain C Mark approval for CytoSorb in the EU and begin commercializing it this year in fact.

We plan to take the data from this trial and present it to the FDA who has already approved an IDE application and investigational device exemption application that they approved in 2007 to run a limited sepsis study and look to them to now begin a pivotal study in the US in either late 2010 or currently 2011 to allow commercialization in the United States as well.

We recently announced preliminary positive proof of concept in humans, using Cytosorb to treat severe sepsis patients in the setting of lung injury in a 22 patient randomized control pilot study. We reported a summary of clinical data from all 13 patients that had fully monitored, completed data sets – this is 7 treated, 6 control patients – that demonstrated improvements with Cytosorb treatment in key clinical endpoints. So we think the therapy has been safe. There have been no serious device related adverse events in more than 500 human treatments, more than 150 of which have actually been in patients with sepsis.

So, the underlying technology is protected by a broad intellectual property portfolio of now 27 issued patents, with multiple applications pending that range from composition of matter to clinical application patents. A key part of our know-how is related to polymer production, which we conduct at our manufacturing facility in New Jersey under strict, well documented, reproducible processes that meet FDA clinical trial standards.

BioMedReports: You just said something interesting that I wasn’t aware of – you said that the Cytosorb technology can also clear a person from drug substances?

Dr. Chan: Our polymer platform technology is a highly porous polymer bead. We can change the size and the pore distribution of those pores to enable the removal of different things of different sizes. So the Cytosorb resin is actually specifically designed to remove a bin of substances in the specific weight range we call the cytokine ‘sweet spot’, typically 10 to 50 Kilodaltons (molecular weight) which is where most of the cytokines reside, and that’s exactly where Cytosorb targets. We have the ability to change those pores and pore size and pore distribution to be able to remove things that we want. We actually have a number of different resins that can remove different things from blood and physiologic fluids.

[For instance] imaging a sponge, the sponge looks very porous. We can make those pores very large or very small, and they trap things that are either very large or very small respectively.

BioMedReports: What is the market potential for this product. Can you tell us a little about that?

Dr. Chan: Severe sepsis is often called overwhelming infection and is one of the leading causes of death in the world. It afflicts people of all ages, particularly the very old and the very young, and it also afflicts all walks of life and all ethnicities. Unfortunately, all of us on the phone and elsewhere know someone who has developed a severe infection. It could be something as catastrophic as a ruptured appendix, or something more common as pneumonia, maybe a bad urinary tract infection or even influenza where the infection has gotten out of hand and sent that person to the intensive care unit on life support, with failing critical organs like the hearts, lungs, and kidneys. So this is severe sepsis and it afflicts more than a million people in the United States, roughly 1.5 million people in Europe, and an estimated 18 million people worldwide every single year. Despite the best medical care here in the United States, one in every three patients die of this disease, and in fact, more people die of severe sepsis in the United States than either heart attacks or strokes or any single form of cancer, so it’s a major unmet medical need.

Without better treatments for severe sepsis and its more deadly cousin septic shock, which has a mortality rate of about 50% or more, the numbers are only expected to grow with trends like an aging population and an increase in antibiotic resistant bacteria, the increased use of implantable devices like artificial hips and knees, diseases like diabetes and cancer, all put people at high risk of infection and sepsis, and all of these are driving the incidents of sepsis higher. So right now, Cygress? From Eli Lilly (NYSE: LLY) is the only product approved in the United States or Europe to treat to treat severe sepsis. It is a good drug, but it has had limited adoption by clinicians because of concerns about cost, efficacy, timing of use as well as potentially deadly side effects – well, I should say potentially ‘dangerous’ side effects. So this really leaves a wide open market for other sepsis treatments and we estimate that the total addressable market for Cytosorb in the US and the EU to be collectively about $6 to $8 billion dollars. We also believe that China and India represent extremely large follow up markets for us.

BioMedReports: You know it’s interesting, we spoke to doctors about your technology to get their feel for it and the reaction we heard most was “Wow, is this real? And if it is, we could really use something like this.”  Do you get the same type of reaction out there?

Dr. Chan: We do. We talked to a number of thought leaders in this space. As clinicians should react, they were cautiously optimistic. They wanted, obviously, to see data, but they felt that this was really an approach worth pursuing and an approach that could actually really work. And so hopefully with some of the data that we’ve shown from our pilot study, we’re getting to that point.

BioMedReports:What is the potential impact that Medasorb can have in that market we just talked about?

Dr. Chan: I think that to understand how our science and technology works, it’s important to understand the path physiology of severe sepsis. Severe sepsis is really caused by two problems. One, is the infection, which can often be treated by antibiotics or other types of agents and can be addressed effectively. However, the other facet of sepsis is really the body’s immuno response to the infection. Normally the body produces things called cytokines that help stimulate and regulate the immune system, and they’re normally helpful. But in severe infection and in many people, the body’s immune system goes haywire and produces massive amounts of these cytokines to point where they’re no longer helpful but in fact, they are actually toxic to the body and can directly kill cells and damage organs leading to organ failure and in many cases, death.

So for instance, certain cytokines can cause blood vessels in the lungs to become leaky, allowing inflammatory fluid, cells and other cytokines to fill up the lungs and the person drowns in essentially his or her own fluids. Cytokine storm can also lead to hemodynamic collapse, where the heart can no longer get blood and oxygen to critical organs, leading again, to organ injury. Cytokine storm can also shut down the kidneys, which is another major risk factor for death from severe sepsis. So the role of cytokine storm in sepsis is widely accepted by clinicians and researchers, and has been very well researched, and I always point to the fact that if you do a pub-med search on cytokines and sepsis you’ll literally bring up 10,000 articles.

To drive the point home, there was a Phase I study done by another company in 2006 that was reported by the New England Journal of Medicine. What they had developed was a monoclonal antibody that was designed to stimulate the immune system to treat cancer. When they actually injected this antibody into six healthy young male volunteers, who did not have infection or cancer – they were healthy, they all developed cytokine storm and then all developed the hallmarks of severe sepsis including acute lung injury, renal failure, clotting disorders, and in fact, two of the patients, two of the volunteers who had the worse cytokine storm actually developed severe septic shock and acute respiratory distress syndrome.

This is just an example of how it is not the infection, but rather the cytokine storm that causes multi-organ failure and sepsis. The reduction of cytokine storm has been the Holy Grail for the industry for the past 2 to 3 decades, and unfortunately most of the approaches that have been tried have only been capable of removing one cytokine or one inflammatory mediator at a time.  The problem is that different cytokines have overlapping functions and there’s so much redundancy in the immune response that if you remove one cytokine, even if it’s an important one, twenty others will take its place. So what is really necessary is a broad spectrum approach to try and remove cytokines across the board, and reduce them to a level where they are no longer toxic, but not reduce them so much that they can no longer help the body fight infection. And that technology has not been available until just recently, and with Cytosorb, we are one of the leaders in that field.

Cytosorb is a very effective cytokine filter that can broadly remove cytokines from blood. The treatment is very simple. You use a standard dialysis machine found in most hospitals by leading vendors like Baxter, B. Braun and others, to essentially pump blood out of the body through our cartridge. The blood goes directly through our cartridge and contacts the resin. Cytokines are absorbed and removed from blood and that purified blood is then put back into the body. We treat for 6 hours a day for 7 days each day with a new device. We have the ability to treat an entire person’s blood volume 20 to 30 times over the course of a 6 hour treatment. So the goal is really to reduce cytokine storm, prevent and limit organ damage and allow the body time to heal and recover.

We believe that our device is extremely effective at removing cytokines from blood. We know this from our invitro studies that we’ve done where we can remove 50 to 70% of certain cytokines in the first hour of treatment, and over the course of four hours actually remove 90 to 95% of certain cytokines.

In our bench top circulation system that simulates treatment. Our polymer resin is highly hemo-compatible. It meets what is called the ISO-10993 standard for 30 day medical device implantables. That includes things like bio-compatibility, hemo-compatibility, cyto-toxicity, geno-toxicity, acute sensitivity and other factors. Our device also has massive capacity unlike a standard hemo-dialyzer that has very limited capacity to bind cytokines because of very limited surface area. A single one of our cartridges has 7 football fields worth of surface area in which to bind cytokines. That is really important and a major differentiator between our technology and others based on that capacity because you need massive capacity to impact cytokine storm.

Our technology is also what we call a ‘razor blade in other people’s razor’ model, because it is compatible with standard hemo-dialysis equipment. It also contains no cells, no antibodies, nothing that can degrade over time, so it has excellent shelf life stability. We currently have 3 year shelf life stability at room temperature. It really does have a number of significant advantages over other technologies, most of which don’t work.

BioMedReports: Let’s talk about the trials in Europe. Has it been easier to accrue patients there then if you had done the trials in the US for example?

Dr. Chan: We continue to make good progress. We’re working with a stellar group of experienced and motivated investigators, many who are thought leaders in critical care in Germany. That’s very important. Germany, as you know, is the largest medical device market in the EU and the 3rd largest in the world, so it makes a great first market for us. There have been a number of issues related particularly to distance, language as well as time differences that pose a number of different challenges, but we’ve learned to adapt.

BioMedReports: Tell us about any additional goals for the company for 2010?

Dr. Chan: I think that is the major goal and that is the event that will drive the greatest shareholder value for the company, the successful completion of our trial as well as getting C mark approval. We have a number of other initiatives under way that I can’t talk about right now but we hope those will also bear fruit for the company and represent a potential upside for investors.

BioMedReports: What are the challenges you see for the company in  2010?

Dr. Chan: One of the major challenges for us is that we have a lot going on at the company with a lot of moving parts. There are a lot of things we need to accomplish this year including completing trials, strategic partnership discussions, a C Mark approval, beginning commercialization, regulatory discussions with the FDA, other things along those lines. I would say that we do have a very strong management team and we are working diligently to execute on our vision. We’re in the midst of preparing our C Mark application to try and speed approval if we complete our trial successfully.

BioMedReports: Have you discussed any strategic partnerships to go to market or to do the trials for example?

Dr. Chan: If our technology works as we hope, it really has the potential to be a blockbuster product that can impact the top and bottom lines of most potential strategic partners. We have a very active business development program under way at the company that’s been going on now for more than a year.

Cytostorb is an extensively patented product. It has a highly profitable business model. It’s in a market that has little competition and literally has a world of opportunity in front of it. We believe it’s a technology that is attractive to potential investors and hopefully with positive data from our trial we can make something happen there, but we aren’t dependent on a strategic partnership. Whether we partner with a larger company or take the product to market directly, we’re prepared to do either.

 

MedaSorb's (MSBT.OB) Answer to Unmet Medical Need Could Be  Commercialized This Year
 
Date : 02/08/2010 @ 8:13AM
 Source : MarketWire
Stock : BioMedReports (MSBT)
 
http://ih.advfn.com/...642432&article=41436372&symbol=NB^MSBT  
 
LOS ANGELES, CA -- (Marketwire) -- 02/08/10 --
 
 BioMedReports.Com, the news portal which covers Wall Street's biomedical  sector and delivers financial and investment intelligence to a  community of highly informed investors, is reporting that MedaSorb  Technologies' (OTCBB: MSBT) flagship product CytoSorb? -- a therapeutic  device, may be a Holy Grail which has eluded medicine for decades
 
 Severe sepsis is a life-threatening condition, which affects over 18  million people each year
 
"Unfortunately, most know someone  who had developed a severe infection. It could have been something as  catastrophic as a ruptured appendix, or something more common as  pneumonia, maybe a bad urinary tract infection or even influenza --  where the infection got out of hand and sent that person to the  intensive care unit on life support, with failing critical organs like  the hearts, lungs, and kidneys," says Dr. Phillip Chan, MD, PhD, the  Chief Executive Officer of the company
 
"Despite the best  medical care here in the United States, one in every three patients die  of this disease, and in fact, more people die of severe sepsis in the  United States than from either heart attacks or strokes or any single  form of cancer. It remains a major unmet medical need."
 
While  massive resources have been invested in developing and evaluating  potential therapies, MedaSorb is conducting human trials in Europe and  has already announced preliminary positive proof of concept in humans,  using CytoSorb? to treat severe sepsis patients
 
"Our major  goal (for 2010) is the successful completion of our trial, which will  hopefully lead to CE Mark approval," Chan said
 
The complete  report is available now at BioMedReports.Com:
 
http://biomedreports.com/articles/most-popular/...ere-infections.html  
 
Biotech investors interested in accessing the news portal's  complete database of clinical trials and upcoming FDA decisions can  access that information here:
 
http://biomedreports.com/fda-calendar/fda-calendar.html  
 
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MedaSorb Technologies Corporation Improves Cash Position and Hits Midway Point in Study Enrollment

Date : 02/17/2010 @ 7:30AM
Source : MarketWire
Stock : MedaSorb Technologies Corporation (MSBT)

http://ih.advfn.com/...pid=nmona&article=41588105&symbol=MSBT

MONMOUTH JUNCTION, NJ -- (Marketwire) -- 02/17/10 --

MedaSorb Technologies Corporation (OTCBB: MSBT) and its wholly-owned subsidiary, CytoSorbents, Inc., announced that it was approved to participate, for its second year, in the New Jersey Emerging Technology and Biotechnology Financial Assistance Program. CytoSorbents was approved by the State to sell additional net operating losses, which has resulted in net proceeds of approximately $299,000 to the Company.

"This additional improvement in our cash resources will be used to continue the funding of our European Sepsis Trial -- evaluating the treatment of patients with severe sepsis and respiratory failure," commented Dr. Phillip Chan, CEO. "The proceeds from the sale of our net operating losses have additional benefit as a non-dilutive event for our shareholders. We are also pleased to announce the receipt of $80,000 from the University of Pittsburgh Medical Center, for our fourth year of sub-contracting work in support of their NIH grant studying sepsis. Additionally, we are excited to have enrolled our 50th patient, reaching the midway point in our 100 patient trial, and are continuing to work with all sites to maximize enrollment."

About MedaSorb, CytoSorbents and CytoSorb?

MedaSorb Technologies Corporation, and its operating subsidiary, CytoSorbents, is a therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb?. Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza.

It afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Much of the organ failure and mortality in severe sepsis is caused by the abnormal massive production of cytokines by the immune system, often called "cytokine storm." CytoSorb? is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped through the CytoSorb? cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using its flagship CytoSorb? device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. CytoSorb? is one of a number of different resins designed for different medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, drug detoxification and others.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. MedaSorb Technologies Corporation and CytoSorbents, Inc. believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-KSB filed with the SEC on April 10, 2009, which is available at http://www.sec.gov.

Contact: David Lamadrid CytoSorbents, Inc.

(732) 329-8885 ext. 816 davidl@cytosorbents.com

FOR THE FISCAL YEAR ENDED DECEMBER 31, 2009

http://ih.advfn.com/...d=nmona&cb=1270880690&article=42324927

...

The number of shares outstanding of the registrant’s Common Stock as of April 5, 2010 was 82,574,856


Clinical Studies

Our first clinical studies were conducted in patients with chronic renal failure. The health of these patients are challenged by high levels of toxins circulating in their blood but, unlike sepsis patients, they are not at imminent risk of death. The toxins involved in chronic renal failure are generally different from those involved in sepsis, eroding health gradually over time. The treatment of patients with chronic renal failure is a significant target market for us, although not the current focus of our efforts and resources. Our clinical studies and product development work in this application functioned as a low risk method of evaluating the safety of the technology in a clinical setting, with direct benefit to the development of the critical care applications on which we are now focusing our efforts.

The Company is focusing its research efforts on critical care applications of it technology.  We are currently enrolling patients in a European Sepsis clinical study.

We received approval from the German Ethics Committee in October of 2007 to conduct a clinical study of up to 80 patients with acute respiratory distress syndrome or acute lung injury in the setting of sepsis.

In April 2009, we submitted a protocol revision to expand the options for anti-coagulation that the clinical sites may use, and to increase the total number of patients that may be enrolled from 80 to 100 patients.  This revision has been approved by the German Ethics Committee. We believe that the revised protocol will enable more potential sites to participate in the study, and may help accelerate patient enrollment through greater access to potential candidates.

Additionally, we have updated blood sampling and handling procedures to minimize non-device related artifacts that may potentially arise if the samples are not processed appropriately.

By December 31, 2009 we had initiated and opened for enrollment a total of fourteen (14) hospital units to participate in our clinical study.  To date we have enrolled sixty (60) patients in the clinical study. We may enroll up to an additional forty (40) additional patients.  In conducting the German Clinical study we have utilized our CytoSorb™ device in approximately 175 treatments to date with no Serious Adverse Events attributable to the device.

Depending on the rate of enrollment, we expect to complete the patient enrollment in the second half of 2010 to the first quarter of 2011. Concurrent with the clinical study, we have commenced our preparation for the CE Mark submission process. Assuming availability of adequate and timely funding, a successful outcome of the study, and CE Mark regulatory approval, the Company intends to commercialize its product in Europe.

Because of the limited studies we have conducted, we are subject to substantial risk that our technology will have little or no effect on the treatment of any indications that we have targeted.

Employees

As of December 31, 2009, we had seven employees. None of our employees are represented by a labor union or are subject to collective-bargaining agreements. We believe that we maintain good relationships with our employees.

We require additional capital to continue operations.

As of December 31, 2009 we had cash on hand of $1,595,628, and current liabilities of $970,765.  We will need additional financing in the future in order to complete our clinical studies and the commercialization of our proposed products.  There can be no assurance that we will be successful in our capital raising efforts.


...

MedaSorb Technologies Announces Company Name Change to CytoSorbents Corporation

Date : 05/06/2010 @ 6:18PM
Source : MarketWire
Stock : MedaSorb Technologies Corporation (MSBT)

http://ih.advfn.com/...pid=nmona&article=42701834&symbol=MSBT

MONMOUTH JUNCTION, NJ -- (Marketwire)
05/06/10
MedaSorb Technologies Corporation, formerly trading under the symbol (OTCBB: MSBT), has formally changed its company name to CytoSorbents Corporation. Pursuant to the name change, effective at the open of business on May 7, 2010, the new ticker symbol for the Company will be (OTCBB: CTSO).

For additional information on the Company, please see our Form 10-K filed with the SEC on April 9, 2010 under our former name MedaSorb Technologies Corporation, which is available at www.sec.gov.

About CytoSorbents and CytoSorb?

CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb?. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to the unregulated, massive production of cytokines, often called "cytokine storm," that then causes severe inflammation, organ failure and often death.. CytoSorb? is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped through the CytoSorb? cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb? to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb? in the European Union. CytoSorb? is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 9, 2010, which is available at http://www.sec.gov.

Contact:

CytoSorbents Corporation

David Lamadrid

(732) 329-8885 ext. 816

davidl@cytosorbents.com

Seit einiger Zeit habe ich "Medasorb" Aktien in meinem Depot liegen.Worauf ich spekuliere ist jedem klar, nur was passiert jetzt mit meinem Bestand?
Eine Namensänderung habe ich in meiner Börsenzeit noch nicht mitgemacht!
Ich bin wirklich jedem dankbar für einen guten Ratschlag bzw. erfahrenen Beistand!
Vielen Dank  

a)es gibt einen Namens- / ISIN-Nr.-Wechsel
...ansonsten passiert nichts weiter (kein R/S, kein ausbuchen etc.)

In Dtl. ist z.Z. der Handel deswegen ausgesetzt ( siehe: http://www.finanznachrichten.de/...a-aussetzungen-suspensions-029.htm ), in USA wird mit heutigen Handelsbeginn ( siehe:  http://ih.advfn.com/...pid=nmona&article=42701834&symbol=MSBT ) unter neuem Namen ganz einfach weitergehandelt...

Vielen Dank für ihre Info!
Wofür ich mich persönlich noch bedanken will ist ihre Arbeit in diesem Thread!
Sehr informativ!!!!
Wie gesagt seit langen schon dabei und bereit  im richtigen Augenblick ein paar mehr zu erwischen!
In diesem Sinne,vielen Dank und viel (sehr viel) Erfolg  

May 10, 2010 10:49 ET
http://www.marketwire.com/press-release/...ding-Agreement-1257157.htm

CytoSorbents Corporation Enters Into Funding Agreement

MONMOUTH JUNCTION, NJ--(Marketwire - May 10, 2010) -  CytoSorbents Corporation (OTCBB: CTSO), formerly known as MedaSorb Technologies Corporation, a therapeutic device company, engaged in research, development, manufacture, and commercialization of blood purification technologies, announced today that on May 5, 2010, it signed a $6 Million purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor. At such time as the SEC has declared effective a registration statement related to shares underlying the transaction, the Company will have the right over a 25-month period to sell shares of its common stock to LPC from time to time in amounts between $50,000 and $750,000, depending on certain conditions, for up to $6 million in the aggregate. The purchase price of the shares will be based on the prevailing market prices of the Company's shares at the time of sales without any fixed discount, and the Company will control the timing and amount of any sales of shares to LPC. There are no negative covenants, restrictions on future financings, penalties or liquidated damages in the purchase agreement. The proceeds received by the Company under the agreement will be used to complete the European Sepsis Trial, pursue CE Mark approval and commercialization of CytoSorb™, expand its product pipeline, and for general working capital purposes. A more detailed description of the agreement is set forth in the Company's Current Report on Form 8-K to be filed with the SEC which the Company encourages investors to review carefully.

"As we continue to progress in our European Sepsis Trial, we believe that our agreement with LPC will help us to opportunistically fund our business on favorable terms," said Dr. Phillip Chan, CEO and President of CytoSorbents Corporation.

About CytoSorbents and CytoSorb™

CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb™. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to the unregulated, massive production of cytokines, often called "cytokine storm," that then causes severe inflammation, organ failure and often death. CytoSorb™ is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped through the CytoSorb™ cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb™ to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. CytoSorb™ is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com

About Lincoln Park Capital (LPC)

LPC is an institutional investor headquartered in Chicago, Illinois. LPC's experienced professionals manage a portfolio of investments in public and private entities. These investments are in a wide range of companies and industries emphasizing life sciences, energy and technology. LPC's investments range from multiyear financial commitments to fund growth to special situation financings to long-term strategic capital offering companies certainty, flexibility and consistency.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 9, 2010, which is available at http://www.sec.gov/.

SOURCE: CytoSorbents Corporation (fka MedaSorb Technologies Corporation)

Contact:
CytoSorbents Corporation
David Lamadrid
(732) 329-8885 ext. 816
davidl@cytosorbents.com

Die Kurse im Moment gefallen mir ja echt gut da ich ja die Absicht habe welche zu ordern.Nur wann sind die hier in D wieder handelbar?Man is ja im Augenblick mit in D gekauften shares so ziemlich dem Ami ausgesetzt!
Auf eine erfolgreiches Investment in diese Firma!MfG Dr.Watson-09  

http://www.ariva.de/quote/simple.m?secu=103069850
http://www.ariva.de/quote/simple.m?secu=100383949

Company Name Change to CytoSorbents Corporation

MedaSorb Technologies Announces Company Name Change to CytoSorbents Corporation

Date : 05/06/2010 @ 6:18PM
Source : MarketWire
Stock : MedaSorb Technologies Corporation (MSBT)

http://ih.advfn.com/...pid=nmona&article=42701834&symbol=MSBT

MONMOUTH JUNCTION, NJ -- (Marketwire)
05/06/10
MedaSorb Technologies Corporation, formerly trading under the symbol (OTCBB: MSBT), has formally changed its company name to CytoSorbents Corporation. Pursuant to the name change, effective at the open of business on May 7, 2010, the new ticker symbol for the Company will be (OTCBB: CTSO).

For additional information on the Company, please see our Form 10-K filed with the SEC on April 9, 2010 under our former name MedaSorb Technologies Corporation, which is available at www.sec.gov.

About CytoSorbents and CytoSorb?

CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb?. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to the unregulated, massive production of cytokines, often called "cytokine storm," that then causes severe inflammation, organ failure and often death.. CytoSorb? is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped through the CytoSorb? cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb? to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb? in the European Union. CytoSorb? is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 9, 2010, which is available at http://www.sec.gov.

Contact:

CytoSorbents Corporation

David Lamadrid

(732) 329-8885 ext. 816

davidl@cytosorbents.com

herzlichen Dank!Das ging ja wieder flott!
Hmm,es gibt ja hier nur 2 Möglichkeiten was mit unserem Geld passieren kann.
ich bin selber positiv gestimmt frage mich jedoch "Warum solche Kurse?"
An der Börse wird ja die Zukunft mit viel Fantasie (manchel zuviel) gehandelt.Im Erfolgsfall können wir die Gewinne ja noch gar nicht beziffern bei Misserfolg scho, 0!
Aber warum bekommt dieses Unternehmen so wenig beachtung bzw.einen vernünftigen Handel?
Wenn der Knaller kommen sollte jammern wieder Tausende "Das hätte man sehen müssen!Wie Vermil.... und alle nicht dabei gewesen!"

Ich für meinen Teil habe manches mal echt ein Glückliches Händchen gehabt (oft auch Zufall, geb ich zu)
Oft aber eben auch mal nicht.
Jetzt stehe ich vor der Frage "Noch mehr kaufen oder noch etwas zögern und hinterher schlauer/dümmer zu sein?"

Wenn hier etwas kommt dann plötzlich!
Aber wie stehen die Chancen Ihrer Meinung nach tatsächlich noch nen besseren Einstieg zu erwischen?
Jetzt mal vom Spread abgesehen finde ich die Kurse doch schon wieder sehr atraktiv!?

Noch mal vielen Dank für ihre Unterstützung und ihre Antworten auf meine Fragen!  

Bezogen auf mein vorrangegangenes Posting:
Keine kaufempfelung!Aktien können steigen oder fallen und der Handel mit Aktien beinhaltet grundsätzlich das Risiko des Totalverlustes!  

CytoSorbents Corporation to Present at the In3 East Medical Device Conference

Date : 06/08/2010 @ 7:30AM
Source : MarketWire
Stock : CytoSorbents Corporation (CTSO)

http://ih.advfn.com/...=nmona&article=43136544&symbol=NB^CTSO

CytoSorbents Corporation (OTCBB: CTSO) announced that its Chief Executive Officer and President, Dr. Phillip Chan, will deliver a presentation at the In3 East Medical Device Conference at the Westin Copley Place Hotel in Boston, MA on Thursday, June 10, 2010 at 3:20PM EDT. www.in3east.com

"As we work towards CE Mark approval of our flagship product CytoSorb?, we are pleased to discuss the numerous potential clinical applications of our technology with potential investors and strategic partners. CytoSorb? was uniquely designed to reduce cytokine storm, or the excessive overproduction of cytokines, responsible for the severe inflammation, organ failure and patient death seen in many critical care diseases. Most of these diseases, such as severe sepsis and septic shock, burn and smoke inhalation injury, acute respiratory distress syndrome, acute severe pancreatitis, advanced influenza, trauma and others have limited treatment options and are typically treated with only supportive care therapies and watchful waiting today. CytoSorb represents a new generation of 'active' therapies that can potentially reverse or eliminate the underlying damaging cytokine storm, allowing patients to heal and recover faster and to get out of the hospital alive more quickly. We believe the future treatment of critical care diseases revolves around this important concept."

CytoSorbents Corporation to Present at BioNJ BioPartnering Conference

Date : 05/24/2010 @ 2:06PM
Source : MarketWire
Stock : CytoSorbents Corporation (CTSO)

http://ih.advfn.com/...=nmona&article=42950960&symbol=NB^CTSO

CytoSorbents Corporation (OTCBB: CTSO), formerly known as MedaSorb Technologies Corporation, announced that Dr. Phillip Chan, Chief Executive Officer and President, will present at the BioNJ BioPartnering 2010 Conference on Tuesday, June 15, 2010 at the Westin Princeton in Princeton, New Jersey. The presentation will take place at 10AM in Salon G. http://bionj.org/biopartnering2010

"We have a powerful and flexible, polymer-based purification platform that can remove a variety of substances from blood and other physiologic fluids based on size and surface adsorption," stated Dr. Phillip Chan. "CytoSorb™ is a cytokine filter in clinical trials that can potentially be used to reduce deadly inflammation and cytokine storm in a variety of life threatening diseases treated in the intensive care unit, such as severe sepsis, acute respiratory distress syndrome, and burn injury. We also have a number of different polymer resins that have the ability to remove things as small as drugs with, in some cases, more than 90% single pass extraction efficiency to substances as large as antibodies. Our engineers also have the ability to rapidly modify our core technology to remove substances of specific interest to potential partners with a number of key advantages over other standard technologies."

Company Name Change to CytoSorbents Corporation

MedaSorb Technologies Announces Company Name Change to CytoSorbents Corporation

Date : 05/06/2010 @ 6:18PM
Source : MarketWire
Stock : MedaSorb Technologies Corporation (MSBT)

http://ih.advfn.com/...pid=nmona&article=42701834&symbol=MSBT

MONMOUTH JUNCTION, NJ -- (Marketwire)
05/06/10
MedaSorb Technologies Corporation, formerly trading under the symbol (OTCBB: MSBT), has formally changed its company name to CytoSorbents Corporation. Pursuant to the name change, effective at the open of business on May 7, 2010, the new ticker symbol for the Company will be (OTCBB: CTSO).


http://www.ariva.de/quote/simple.m?secu=103069850
http://www.ariva.de/quote/simple.m?secu=100383949