Healthcare Industry News: blood purification
News Release - July 30, 2007
MedaSorb to Pursue 6 Billion Dollar Sepsis Market in EuropeMONMOUTH JUNCTION, NJ--(Healthcare Sales & Marketing Network)--Jul 30, 2007 -- MedaSorb Technologies Corporation (OTC BB:MSBT.OB ) (Frankfurt:HQE.F ) announced today that it will pursue the CE Mark for approval to market CytoSorb in Europe. The CE Mark is the regulatory pathway for approval of a medical device in the European Union.
"We believe obtaining the CE Mark provides the best and fastest route to commercialization," MedaSorb's CEO, Al Kraus commented. "Our business strategy is to penetrate the European market first, followed by the US and global markets." The company estimates the European sepsis market potential is over 6 billion dollars.
Sepsis is a major cause of mortality, killing 1,400 people worldwide every day. The estimated incidence of sepsis is 1.0 million patients per year in the U.S., with an estimated annual economic cost of $18 billion and approximately 215,000 deaths. It is estimated that Europe has similar statistics.
Our CytoSorb(TM) medical device has been shown effective in removing cytokines, which are believed to be key mediators in the inflammatory and often deadly response of the immune system to sepsis. MedaSorb believes CytoSorb will be clinically effective as an adjunctive therapy in the treatment of sepsis, by reducing the harmful level of cytokines in patients.
Other intended applications include the prevention of post-operative complications of cardiac surgery, prevention of damage to organs donated for transplant prior to organ harvest, short and long-term treatment of kidney failure, and drug detoxification.
Citing their earlier published quarterly statement, MedaSorb has received conditional approval from the United States Food and Drug Administration (FDA) to conduct its CytoSorb clinical study for acute respiratory distress syndrome (ARDS) in the setting of sepsis. We will continue to work with the FDA to obtain approval for additional patients in the study. We have proposed expanding the number of patients incrementally as the study progresses.
Sepsis is a condition that can result from a person's over-response to infection or injury. Approximately 50% of the 2 million worldwide sepsis cases lead to death and is the second most frequent cause of death in hospitals outside the cardiac ICU. Severe sepsis is often more dangerous than the initial infection and, without rapid diagnosis and intervention, can develop within a matter of hours, leading to septic shock which can cause temporary or permanent damage to multiple organs or even death.
MedaSorb Technologies Corporation is a medical device company preparing to commercialize blood purification technology that effectively removes toxic compounds from circulating blood. MedaSorb's initial products, CytoSorb(TM) and BetaSorb(TM), are known medically as hemoperfusion devices and incorporate proprietary adsorbent polymer technology. Management believes the potential healthcare applications for its products include: adjunctive treatment of sepsis, prevention of damage to organs donated for transplant prior to organ harvest, prevention of post-operative complications of cardiac surgery, and the short- and long-term treatment of kidney failure. MedaSorb is headquartered in Monmouth Junction, New Jersey. http://www.medasorb.com/
Safe Harbor Statement
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 believes that its primary risk factors include, but are not limited to: 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; obtaining government approvals, including required FDA approvals; 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 Current Report on Form 8-K filed with the SEC on July 6, 2006, which is available at http://www.sec.gov
Source: MedaSorb Technologies
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