NovaShunt initiates study to evaluate AFS for refractory ascites patients

NovaShunt today announced the initiation of its pivotal multi- center clinical study named PIONEER, a Prospective, multi-center, open label, non-randomized study to Investigate the safety and perfOrmance of the Automated Fluid ShuNt in patiEnts with ascitEs and diuretic Resistance.

The study is designed to evaluate the safety and performance of the Automated Fluid Shunt (AFS) System in replacing the need for paracentesis, the standard therapy for patients with refractory ascites. Secondary parameters in the study are concomitant reduction in the need for medication, health care costs (hospitals stays, treatment) and patients' quality of life. Data from the PIONEER study will be submitted to the Notified body to obtain CE Marking which will allow NovaShunt to enter the European market. The study is being led by the Principal Investigator Dr. Jose Such, Head of Hepatology, University General Hospital, Alicante, Spain, and will be initialized in five university hospitals in Europe specialized in managing patients with refractory ascites (located in Alicante, Barcelona, Frankfurt, Regensburg and London).

"We are very excited to begin the clinical evaluation of a novel technology for the treatment of patients with refractory ascites," said Dr. Such, Head of Hepatology, University General Hospital, Alicante, Spain. "As there are many patients in our clinic suffering from decompensated cirrhosis and the presence of ascites, the AFS System could be of great benefit for these people."

The AFS System is an implantable, battery powered pump that automatically 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."