NovaShunt Starts its Pivotal Clinical Study "PIONEER" to Demonstrate the Clinical Value of the AFS SystemBy Novashunt Ag, PRNE
Wednesday, February 10, 2010
ZUG, Switzerland, February 11 - 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
"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
"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
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 automatically and
continuously collects fluid as it forms in the abdominal cavity and moves it
to the bladder, where it is naturally passed from the body. The patient can
wirelessly recharge the battery through the skin, using a simple charger.
This charger also collects pump and patient data which can be easily
downloaded to a computer and reviewed by the patient's physician.
The number of people with ascites will grow substantially over
the next decade due to accelerating incidence of hepatitis and
obesity-related liver disease (NAFLD). The current standard treatment for
these patients is called 'paracentesis', a procedure in which a large bore
needle is inserted into the patient's abdomen, sometimes weekly or bi-weekly,
to remove between 5-10 liters of accumulated ascites. The cumulative cost of
repeat paracentesis for these patients often exceeds EUR25,000 each year.
NovaShunt is a privately owned Swiss medical device company
that is dedicated to improving patient lives through the development,
manufacture and commercialization of automated implantable pump systems to
manage fluid balance within the body. NovaShunt is focused on areas of unmet
clinical need where its products can significantly improve clinical outcomes,
reduce health care costs and improve patient quality of life.
"For a long time now I have been feeling much better. I have not had any
paracentesis procedures since the implant and need much less, sometimes even
no diuretics. In summer I went on vacation where I enjoyed swimming and the
Mediterranean Cuisine. I'm active every day and I enjoy my new life."
Liver Patient, Prague, Czech Republic, Implant date: End of March 2009
Contact: Carina Bossi Suess Director Marketing&Communications, Investor and Public Relations +41-78-609-56-49 firstname.lastname@example.org Please visit us at: www.novashunt.com
Contact: Carina Bossi Suess, Director Marketing&Communications, Investor and Public Relations, +41-78-609-56-49, carina.bossi at novashunt.com
Tags: Novashunt Ag, Switzerland, Zug