Sequana Medical Receives CE Mark Approval for the ALFApump™ System and Adds Key Executive to Team

Sequana Medical Receives CE Mark Approval for the ALFApump™ System and Adds Key Executive to Team

PR Newswire

ZURICH, Switzerland, July 13, 2011 /PRNewswire/ —

New Technology Expands Treatment
Options
for Patient With Refractory
Ascites Due
to Liver
Cirrhosis
. Dr. Farzana Malik
Joins as Vice President of Market Access and
Reimbursement.

Sequana Medical announced today that it has received CE Mark
approval for the commercial sale of its ALFApump™ System. Over
the coming months, the company will launch the product in selected
hepatology and liver transplant hospitals across Europe. The
ALFApump System is indicated for the management of refractory and
recurrent ascites due to liver cirrhosis, a condition where massive
and uncontrolled fluid accumulation occurs in the abdominal
cavity.

“This is a major milestone both for our company and for patients
with refractory ascites,” stated Dr. Noel L. Johnson, CEO of
Sequana Medical. “For patients, the treatment options for
refractory ascites have been very limited and carried significant
risks and side effects. The ALFApump System offers a new treatment
tool which can improve patient quality of life while also reducing
hospitalizations. It is a cost-effective solution and we believe
over time it will become the preferred option for patients,
physicians and payers. We are eager to begin our commercial launch
in Europe.”

Sequana Medical’s ALFApump System is a proprietary implantable
pump system designed to remove excess abdominal fluid, known as
ascites, in patients suffering from liver cirrhosis. The ALFApump
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 ALFApump System automatically and
continually collects fluid as it forms in the abdominal cavity and
moves it to the bladder, where it is eliminated through normal
urination. The ALFApump is recharged wirelessly and can be
programmed to meet the unique needs of each patient.

Refractory ascites occurs when patients with ascites no longer
respond to medical therapy. This condition affects over 100,000
patients in Europe and the US every year. The number of patients
suffering from ascites is growing at approximately 10% a year due
to the accelerating incidence of hepatitis- and obesity-related
liver disease. The primary treatment for ascites is paracentesis, a
procedure in which a large bore needle is inserted into the
patient’s abdomen to remove between 5-10 liters of ascites that has
accumulated over a period of a week or two. The cumulative cost of
ascites-related care for these patients often exceeds $50,000 each
year.

“The benefits of the ALFApump System are entirely aligned with
the goals of patients, physicians and payers,” commented Dan Rose,
VP of Commercial Operations. “The system is designed to offer
patients better clinical outcomes and quality of life while
eliminating the requirement for repeated expensive and burdensome
invasive procedures. The performance of the ALFApump System in the
PIONEER Clinical Study has surpassed our expectations and indicates
a bright future for our technology as a new treatment option. We
look forward to partnering with leading hepatology centers as we
launch the ALFApump System in Europe.”

In May, Sequana Medical completed full enrollment of its
40-patient PIONEER Study, a prospective, multi-center, open label
study of patients with refractory ascites due to liver cirrhosis.
The PIONEER Study was designed to evaluate the safety and
performance of the ALFApump System in obviating the need for
paracentesis, the standard therapy for patients with refractory
ascites. The Study was completed in 9 centers across 4 European
countries. Dr. Jose Such, the principle investigator of the
Pioneer Study, stated that, “The ALFApump System CE Marking is
great news for both Sequana Medical and for my patients with
refractory ascites.”

Additionally, Sequana Medical is pleased to announce the
appointment of Dr. Farzana Malik as Vice President of Market Access
and Reimbursement. “Dr. Malik is a Health Economist and brings over
15 years expertise in developing and executing health economics,
pricing and reimbursement strategies in the biotechnology,
pharmaceutical and medical device industries,” said Dr. Johnson.
She comes to Sequana Medical from Alexion Pharmaceuticals, where
she was Head of Pricing and Market Access. Previously, she held
positions at Merck Serono, Medtronic and Pfizer.

About Sequana Medical:

Sequana Medical is a Swiss medical device company dedicated to
improving patient lives through innovative technologies to manage
fluid within the body.

Contact:
Noel L. Johnson
Chief Executive Office
E-Mail: noel.johnson@sequanamedical.com

Phone: +41-44-446-50-71

SOURCE Sequana Medical AG

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