July 13, 2011
Sequana Medical Receives CE Mark Approval for the ALFApump(TM) System and Adds Key Executive to Team
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(TM) 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
"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
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
Contact: Noel L. Johnson Chief Executive Office E-Mail: [email protected] Phone: +41-44-446-50-71
SOURCE Sequana Medical AG