Healthcare Industry News: blood purification
News Release - October 16, 2007
MedaSorb Completes Key Step to Begin Clinical Study in Europe for CytoSorb(TM) in the Treatment of SepsisMONMOUTH JUNCTION, NJ--(Healthcare Sales & Marketing Network)--Oct 16, 2007 -- MedaSorb Technologies Corporation (OTC BB:MSBT.OB ) (Frankfurt:HQE.F ) announced today that they completed the investigators' meeting in Berlin, Germany to support the clinical study of MedaSorb's CytoSorb(TM) hemoperfusion device.
The meeting is a necessary step to begin trials for CytoSorb(TM) as an adjunctive therapy in patients with Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI) in the setting of sepsis. MedaSorb intends to initiate a multi-center trial that will enroll up to 80 patients. A successful trial will support the application process to obtain CE Mark, which is the regulatory process for approval to market a medical device in the European Union. In August the Company received approval to conduct the clinical study in Germany.
"This is a very important step for us in commercializing CytoSorb(TM) and we were encouraged by our reception in Berlin," commented Al Kraus, the CEO of MedaSorb. "Following the award of the CE Mark, we will begin our sales effort to pursue an estimated $6.7 Billion market in Europe."
Dr. James Winchester M.D., a renowned Nephrologist and Chief Medical Officer for the Company, worked on the protocol design and clinical study procedures. His presence at the medical investigators' meeting was important to review the Company's extensive research and experience with CytoSorb(TM).
Dr. Winchester explained the CytoSorb(TM) device as a unique product to help combat sepsis. MedaSorb intends that CytoSorb(TM) help doctors treat sepsis by using a unique hemoperfusion therapy. Less effective approaches to the treatment of sepsis have involved drugs, blood and protein therapies. MedaSorb's patented adsorbent platform technology is designed to remove toxins from the blood and physiologic fluids.
In addition, MedaSorb has retained MedPass, to assist with the administration of the regulatory and safety reporting in Europe. MedPass International is a consulting firm, specializing in European regulation and clinical development of new medical technologies.
MedaSorb Technologies Corporation is a medical device company preparing to commercialize blood purification technology that effectively removes toxic compounds from circulating blood and physiologic fluids. 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, the short- and long-term treatment of kidney failure and drug detoxification. 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 and CE Mark 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 10KSB filed with the SEC on April 30, 2007, which is available at http://www.sec.gov.
Source: MedaSorb Technologies
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