DARPA Awards $3.8 Million Contract to CytoSorbents Corporation (CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a publicly-traded, critical care focused therapeutic device company using blood purification to treat 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. Each polymer bead contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies.

The Company has announced that it has been awarded a technology development contract worth up to $3.8 million by the Defense Advanced Research Projects Agency (DARPA). The contract would be over a period of five years as part of the company’s Dialysis-Like Therapeutics (DLT) program to treat sepsis, pending satisfactory achievement of key milestones. 

DARPA is the U.S. Department of Defense agency responsible for funding cutting-edge programs such as the internet, the global positioning satellite system (GPS), and robotic surgery. In this case, it is funding the development of a portable, artificially intelligent blood purification system that can detect and remove, in real time, substances that can contribute to sepsis, including cytokines, toxins, biowarfare agents, pathogens, and activated cells. The goal is to save the lives of injured warfighters and civilians afflicted with sepsis, where approximately one in every three patients die today, even with the best medical treatment.

Under the terms of this contract, CytoSorbents will develop next-generation broad-spectrum, porous polymers capable of removing cytokines, toxins and certain biowarfare agents from whole blood, with $1.5 million in funding designated for the first year, based upon the achievement of pre-determined milestones.

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated,

"We are delighted to officially begin working with DARPA on this exciting project and are honored to have had our unique core blood purification technology selected for funding. We are one of the industry leaders in the area of blood purification to treat sepsis and other critical care illnesses, with our first-in-class CytoSorb® cytokine filter currently approved and commercialized in the European Union. That being said, under this DARPA program, we are looking to significantly advance our polymer technologies to not only remove cytokines, but also a wide variety of toxins, and do so with little to no anti-coagulation in both high flow and microfluidic systems. The excessive production of cytokines, or 'cytokine storm,' is common in the worst forms of sepsis, and triggers massive inflammation that can lead to organ failure and infection -- the two leading causes of death in the ICU. Meanwhile, toxins produced by bacteria, viruses and other pathogens play an additional devastating role on the body, poisoning or killing cells, leading to widespread tissue destruction and worsened inflammation and sepsis. And the threat of a biowarfare attack with toxins such as ricin and botulinum remains a perennial concern. Our porous polymers are ideally suited to achieve the broad spectrum removal that is needed to counter most of these agents."

Dr. Chan continued,

"Because of the maturity of our technology, we are confident in our ability to meet DARPA's timetable for technology development and strict performance metrics. Over the past several months, we have also collaborated with some of the leading potential systems integrators, to include our technologies into their integration proposals, under a separately funded DARPA DLT solicitation. The role of the systems integrator is to put together the best detection, separation and predictive modeling technologies into a single blood purification system and guide it to human clinical trials within 4 to 5 years. These partnerships are mutually beneficial and will help to contribute to the success of the overall program."

Dr. Chan concluded,

"Just within the recent past, we have seen many high-profile cases of sepsis here in the U.S. including a young woman injured from a fall from a broken homemade zip-line who developed sepsis from a 'flesh-eating' bacterial infection, and a 12-year-old boy who died of unrecognized sepsis after cutting his arm during a basketball game. Unfortunately, these cases are not unusual, with thousands of patients dying silently from sepsis every day in hospitals around the world. The number of sepsis cases in the U.S. alone has doubled in the past decade, and continues to climb due to increased antibiotic resistance, a high rate of hospital-acquired infections, and an aging baby boomer population that is prone to infection due to age, diseases such as diabetes and cancer, and the use of implantable medical devices such as artificial hips and knees. There are currently no approved therapies to treat sepsis in the U.S. or in the European Union. Therapies like CytoSorb® and the device being proposed by DARPA are sorely needed and we are proud to be part of this worthy effort."

Read the full press release here. 

The Crushing Cost of Care @ The Wall Street Journal (CTSO)

In a recent Wall Street Journal article, journalists Janet Adamy and Tom McGinty tell the story of Scott Crawford, a young father who had been healthy his whole life until he was diagnosed with idiopathic dilated cardiomyopathy at age 26. That diagnosis signalled the beginning of a long, painful journey through medication, transplants, surgery, therapy, amputation, and nearly chronic pain, which ended with his death in late 2009. Estimates from Johns Hopkins Hospital in Baltimore, where Mr. Crawford was receiving treatment, put the cost of his Medicare claims at the staggering total of $2.7 million, $766,919 of which remains unpaid. Read the full article here. 

Adamy and McGinty use Mr. Crawford's story as a springboard to discuss Medicare and the shockingly high cost of care in the US. However, something very compelling stands out in Mr. Crawford's story: The frequent mention of sepsis, defined as an overzealous response to a severe infection, as a leading culprit in his downward spiral.

For example, deputy administrator and director for Medicare Jonathan Blum commented that for Mr. Crawford, "a lot of the costs were driven by complications that could have been avoided," citing an early infection as an example. Additionally, after 2 heart transplants, Mr. Crawford developed a severe infenction and had to have his leg above the knee amputated. Shortly before he died, sepsis was again identified as the condition that was overwhelming his system. 

Mr. Crawford isn't the only patient who could have been spared years of pain by catching and treating sepsis early. According to a 2011 brief by the CDC, "an estimated $14.6 billion was spent on hospitalizations for septicemia [In 2008], and from 1997 through 2008, the inflation-adjusted aggregate costs for treating patients hospitalized for this condition increased on average annually by 11.9%. Despite high treatment expenditures, septicemia and sepsis are often fatal. Those who survive severe sepsis are more likely to have permanent organ damage, cognitive impairment, and physical disability. Septicemia is a leading cause of death." Read more here. 

When a person develops sepsis, the body frequently overresponds to the threat by producing a massive excess of cytokines, called cytokine storm. While cytokines normally help the body cope with injury, a cytokine storm "is toxic to the body, driving severe inflammation and a cascade of dangerous 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."

CytoSorbents Corporation (OTCBB: CTSO) is one company working on a solution, that has until recently has not been possible to do.  Its flagship product, CytoSorb®, is a blood filtration cartridge that works to modulate the immune system by removing excess cytokines in critically-ill patients.  If left unchecked, these inflammatory toxins can 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. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death and is now available for sale in Germany 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 its clinical studies. Read more at cytosorbents.com. 

Unnoticed infection turns unstoppable @ The Irish Times (CTSO)

Rory Staunton was a happy, friendly 12-year old boy who wanted to be a pilot when he grew up. He lived with his parents and younger sister in New York. He was quite healthy until he dove for a basketball in his school gym one day and cut his arm. The next day, he was feverish and vomitting. Two days later, he was dead.

Rory died from Strep A Toxic Shock Syndrome, a commonly misdiagnosed condition. In The Irish Times, journalist Jim Dwyer chronicles the dismaying story of how the severity of Rory's condition could escape the notice of his pediatrician as well as the emergency room at NYU Langone Medical Center. 

He writes,

On the first day of his illness, "partially camouflaged by ordinary childhood woes, Rory’s condition was, in fact, already dire. Bacteria had gotten into his blood, probably through the cut on his arm. He was sliding into a septic crisis, an avalanche of immune responses to infection from which he would not escape."

The rest of the story includes doctor miscommunications, inaccurate diagnoses, and even a 12-minute gap between symptom observation and doctor recommendation that could have caught the sepsis early:

"A screening tool in the Stop Sepsis program, used when a patient first arrives in the emergency room, calls special attention to a person with three symptoms of a possible eight. At the hospital, Rory showed two: he was breathing 20 times per minute and his pulse was 143. 

Two hours later, though, he had three: his temperature had risen to 102, his pulse was 131 and his respiration rate was 22. But by the time those vital signs were recorded, at 9.26pm, they had no bearing on his treatment. In fact, the doctor had already decided that Rory was going home. Rory’s 'ExitCare' instructions, signed by his father, were printed 12 minutes before those readings." Read more at The Irish Times. 

Rory's story serves as yet more evidence that sepsis is a looming health problem for the country, and also that it remains underdiagnosed. In addition to correctly diagnosing the illness, it is also crucial to ensure that solid treatment options are available once sepsis is diagnosed. CytoSorbents Corporation (OTCBB: CTSO) is one company making gains in this space. CytoSorbents Corporation is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses, including sepsis. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster. Ultimately the goal is to improve patient outcome and save healthcare costs. 

CytoSorbents’ purification technology is covered by 29 issued patents and is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. The technology has been selected for funding by both the U.S. Army and DARPA (Defense Advanced Research Projects Agency) in a Phase I SBIR grant for trauma, and DARPA’s “Dialysis-like Therapeutics” program for the treatment of sepsis, respectively. The technology is also the basis of the Company’s two lead programs, CytoSorb™ and HemoDefend. Read more at cytosorbents.com.

The Coming “Sepsis Boom" and How to Avert it (CTSO)

In the Medical Labratory Observer, contributor Mark H. Oltermann, MD, writes that due to a variety of factors, the generation known as "the Baby Boom is about to become the Sepsis Boom."

He explains,

"We're seeing an unmistakable increase [in sepsis rates] among all age groups, but particularly among the elderly. There are many factors contributing to this trend. Three of the most dynamic are the aging population, underlying conditions that lead to immunosuppression, and the increase in antibiotic resistance."

Coinciding with the increasing rates of sepsis among the elderly is the actual increasing number of elderly Americans relative to other age groups: 

"We are on the front end of an enormous bulge in the population of Americans who will be 65 and older. The first U.S. Baby Boomers [turned] 65 in 2011, inaugurating a rapid increase in the older population during the 2010 to 2030 period. The older population in 2030 is projected to be double that of 2000, growing from 35 million to 72 million...

In fact, this study shows that the trend of the older population growing at a faster pace than the total population will accelerate dramatically from 2010 to 2040. Whereas the total population of the U.S. is expected to increase by nearly 20% in the two decades between 2010 and 2030, the population of U.S. residents 65 years of age and older will increase at nearly four times that rate (78%) in the same time period."

The bottom line is this: In 2030, nearly 1 in 5 Americans will be aged 65 and older, compared with about 1 in 8 in 2010. Of those elderly Americans, many more will be at risk for sepsis than would have been in previous generations. 

However, not all hope is lost. Oltermann proposes 2 changes to be made that could stem the tide of sepsis cases in the coming years:

"The first [is] to require hospitals to make sepsis one of the core measures that would push for standardizing protocols and reporting of mortality rates. Until that happens, sepsis will be one of hundreds of problems competing for scarce resources and priority status. The second step toward improvement would be to adopt screening tests for sepsis such as lactate and procalcitonin as standard blood tests for all elderly patients who are admitted to the hospital. As noted earlier, this population is at increased risk, and they also may not always display the classic SIRS (systemic inflammatory response syndrome) criteria because of comorbid conditions and concomitant medications." Read more here. 

Though not mentioned in the article, a third step to take would be to ensure that there are solid, reliable treatment options available to help treat sepsis once it is diagnosed. In this space, CytoSorbents Corporation (OTCBB: CTSO) is one company making remarkable gains. CytoSorbents Corporation is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses, including sepsis. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster. Ultimately the goal is to improve patient outcome and save healthcare costs. 

CytoSorbents’ purification technology is covered by 29 issued patents and is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. The technology has been selected for funding by both the U.S. Army and DARPA (Defense Advanced Research Projects Agency) in a Phase I SBIR grant for trauma, and DARPA’s “Dialysis-like Therapeutics” program for the treatment of sepsis, respectively. The technology is also the basis of the Company’s two lead programs, CytoSorb™ and HemoDefend. Read more at cytosorbents.com.

Scientists identify possible drug target for acute pancreatitis ($CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. 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 absorption. CytoSorbents is currently selling its flagship product, CytoSorb®, in Germany with availability in other European countries.

Acute pancreatitis is the inflammation of the pancreas that results in the local release of digestive enzymes and chemicals that cause severe inflammation, necrosis and hemorrhage of the pancreas and local tissues. Approximately 210,000 people in the U.S. are hospitalized each year with acute pancreatitis with roughly 20% requiring ICU care. Overall ICU mortality of severe acute pancreatitis approaches 20%.

Acute pancreatitis is caused most frequently by a blockage of the pancreatic duct or biliary duct with gallstones, cancer, or from excessive alcohol use. Severe acute pancreatitis is characterized by severe pain, inflammation, and edema in the abdominal cavity, as well as progressive systemic inflammation that can lead to multiple organ failure. High levels of cytokines and digestive enzymes can be found in the blood and are correlated to organ dysfunction.

Aside from trying to unclog the duct with endoscopic techniques, there is little that can be done except for bowel rest, aggressive hydration, antibiotics when indicated, and pain control. However, CytoSorb® may potentially improve the outcome of severe acute pancreatitis by removing a diverse set of toxins from blood.

Some recent data from a report in the June 2012 issue of the Journal of Leukocyte Biology demonstrates that one cytokine in particular, IL-6, is associated with worsened outcomes in mice models of pancreatitis. This report "describes experiments in lean and obese mice that identify the presence of high IL-6 as one of the reasons why the disease is more devastating in obese people." 

John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology, stated,

"There is an increasing awareness that obesity and inflammation are connected. Not only does this new report demonstrate an important set of interactions between obesity, pancreatitis, and inflammation, but it also identifies the inflammatory pathway, IL-6, which could represent an important new therapeutic target in these settings." Read more here. 

Amongst its many potential benefits in severe acute pancreatitis, CytoSorb® was clinically proven to reduce IL-6 in critically-ill patients by approximately 50%, and other key cytokines by 30-50%, in CytoSorbents’ European Sepsis Trial that finished last year. CytoSorbents believes severe acute pancreatitis is just one of many life-threatening illnesses that it may be beneficial in.

CytoSorbents: The Next Great Medical Device Growth Story? I say YES! @ MicroCap MarketPlace (CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. 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 adsorption.

At MicroCap MarketPlace, Executive Editor Mike Casson writes that "investors who want real growth in the health care space head to the biotech or medical device sub-sectors. Quite possibly one of the more alluring things about micro-cap biotechnology and medical device firms is that these tiny companies often have cut-and-dry situations." In other words, they do really well or they tank.

Casson believes that CytoSorbents is positioned to be one the companies that growth-hungry investors look for. He writes,

"I think CytoSorbents’ game-changing blood purification technology will revolutionize the way doctors treat life-threatening illnesses in intensive care units and will be a key market driver for the Company...Of course, there are risks with CytoSorbents (this is a development stage company after all) just as there are with most micro-caps, but the key here is the potential rewards seem to far outweigh the risks and the stock probably trades at a valuation that isn’t justifiable, meaning it’s too low."

He goes on to explain 3 additional key investment considerations: CytoSorb's availability in Germany, the Company's strong intellectual property portfolio, and the biggest key of all, the company's management team.

Read his full analysis at MicroCap MarketPlace. 

CytoSorbents to Present at the Marcum MicroCap Conference - $CTSO

CytoSorbents Corporation (CTSO), a critical care-focused company using blood purification to modulate the immune system to prevent or treat organ failure caused by life-threatening illnesses, announced that Dr. Phillip Chan, Chief Executive Officer, will present at the Marcum MicroCap Conference on June 20th in New York City at the Roosevelt Hotel. The event is held by Marcum LLP and co-presented by CCG Investor Relations.

Presentation Details

• Date: Wednesday, June 20, 2012
• Time: 4:00PM
• Location: The Roosevelt Hotel, 45 East 45th Street, New York, NY

A live audio webcast of this presentation will be available through the conference website: http://execvid.com/marcum-microcap-conference-2012

The Marcum MicroCap conference is designed for investors interested in the micro-cap arena, and is expected to gather over 500 participants, including institutional investors, mutual funds, hedge funds, wealth managers, and family offices. The conference will also feature panels on subjects highly relevant to small-cap corporate finance. The event is free to attend for qualified investors and the company will make a formal presentation and be available for one-on-ones.

For full event details and registration information, please visit http://www.marcumllp.com/microcap

About Marcum LLP
Marcum LLP is one of the largest independent public accounting and advisory services firms in the nation. Ranked among the top firms in the nation, Marcum offers the resources of more than 1,100 professionals, including more than 150 partners, in 23 offices throughout New York, New Jersey, Massachusetts, Connecticut, Pennsylvania, California, Florida, Grand Cayman, China and Hong Kong. The Firm's presence runs deep with full service offices strategically located in major business markets. Marcum is a member of the Marcum Group , the gateway to a group of organizations that provide a variety of professional services including accounting and advisory, technology solutions, recruiting, and wealth management. These organizations include Marcum LLP ; Marcum Technology LLC ; MarcumBuchanan Associates LLC ; Marcum Search LLC ; Marcum Financial Services LLC ; Marcum Cronus Partners LLC ; Marcum Bernstein and Pinchuk LLP ; and Marcum Healthcare LLC .

About CCG Investor Relations
CCG is a leading global investor relations and strategic communications consulting firm. In business for more than 30 years, the agency provides a complete range of investor communications, counseling, and IT and data solutions through our global network to over 100 clients across multiple capital markets. CCG has been awarded a number of industry honors for its handling of complex investor relations and crisis communications matters. The agency's corporate headquarters is in Los Angeles with additional offices in New York, Beijing, Shanghai, Hong Kong, London and Tel Aviv. For further information, contact CCG directly, or visit the Company's web sites at http://www.ccgir.com/ and http://www.ccgirasia.com.

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 adsorption. In March 2011, CytoSorb®, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now 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 CytoSorb® is to modulate the immune system by removing excessive cytokines, often called "cytokine storm," in critically-ill patients that can 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. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death and is now available for sale in Germany for the treatment of critical care illnesses under a controlled market release, with a planned broad product launch in Germany starting in the first half of 2012 and availability in other E.U. countries, assuming adequate and timely funding, and continued positive results from our 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 blood products. 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, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, 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 additional 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 and timely 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 March 30, 2012, which is available at http://www.sec.gov.

Contact:
CytoSorbents Corporation
David Lamadrid
Chief Financial Officer
(732) 329-8885 ext. *816
DavidL@cytosorbents.com

Source: CytoSorbents Corporation

Zacks.com initiates coverage of CytoSorbents Corporation, gives Outperform rating (CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. 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 absorption.

Zacks Investment Research has initiated coverage of CytoSorbents Corporation and assigned it an "Outperform" rating.

Senior Medical Device Analyst Brian Marckx writes,

"CytoSorbents' novel blood purification technology aims to revolutionize the treatment of life-threatening illnesses in the ICU.  Patients with critical care illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome and pancreatitis are some of the most seriously-ill and difficult to treat patients in the hospital.  Their CytoSorb device was CE Marked in March 2011 and subsequently commenced its initial commercialization. Near-term game-plan is to build awareness to facilitate broader roll-out in Europe.  FDA approval is a longer-term goal, the quest for which is now in the planning stage."

He continues,

"Despite certain risks, we feel the shares trade cheaper than warranted and are initiating coverage with an Outperform rating."

Read the full report at Zacks.com.