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NovaShunt Starts its Pivotal Clinical Study "PIONEER" to Demonstrate the Clinical Value of the AFS System
Date:2/11/2010

and continuously removes excess fluid - known as ascites - that builds up in the abdominal cavity in patients with liver disease and other conditions.

"This is a milestone in our company history," said Noel Johnson, CEO and co-founder of NovaShunt, "and we strongly believe that this trial will both provide important clinical information and also demonstrate the benefit of continuous removal of ascites by the AFS-System in patients suffering from refractory ascites due to liver disease and other conditions."

Excess fluid build-up, which is known as ascites, in the abdominal cavity is a common complication among patients with late-stage liver disease, congestive heart failure (CHF) and certain cancers. Ascites affects more than a million patients in the EU and US. The majority of patients with ascites can be managed with a sodium-restricted diet and increasingly larger doses of diuretics. However, more than 10% of the patients develop refractory ascites and become non-responsive to diuretic therapy.

"Based on our pre-clinical research and our feasibility study results, the AFS System showed a significant reduction of paracentesis procedures and in the use of diuretics," said Dr. Pedro Eerdmans, Chief Medical Officer of the company. "We've seen some important clinical improvements in the feasibility study patients we enrolled in 2009. The AFS System decreased the overall need for paracentesis by more than 90% in our study group and one patient is fast approaching the one-year anniversary of his implant."

About the Automated Fluid Shunt (AFS) System

NovaShunt's innovative core technology is the Automated Fluid Shunt (AFS) System. The AFS System consists of a subcutaneously implanted battery-powered pump with a catheter placed in the abdominal cavity and another catheter connected to the bladder. The AFS System automatica
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SOURCE NovaShunt AG
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