Sequana Medical Announces Key Opinion
Leader (KOL) Webinar to Discuss alfapump® US Commercial Roll-Out on
January 8th at 15:00 CET / 09:00
EST
- Webinar
to discuss US commercial roll-out following FDA approval of
alfapump® for the treatment of recurrent or
refractory ascites due to liver cirrhosis in December
2024
- alfapump
has received PMA Approval1 and
FDA Breakthrough Device Designation
- Call
participants include Dr. Saab, David Geffen School of Medicine,
UCLA & Dr. Pagadala, Methodist Dallas Medical Center, plus
Sequana Medical management
Ghent, Belgium – 6 January 2025 –
Sequana Medical NV (Euronext Brussels: SEQUA, the "Company" or
"Sequana Medical"), a pioneer in the treatment of
drug-resistant fluid overload in liver disease, heart failure and
cancer, today announces that it will host a KOL webinar focused on
the US commercialization plans for the alfapump.
Sequana Medical management, together with Dr Saab, Professor of
Medicine and Surgery, David Geffen School of Medicine, UCLA and Dr
Pagadala, Transplant Hepatologist, Methodist Dallas Medical Center,
will discuss i) the clinical need in recurrent and refractory
ascites due to liver cirrhosis, including current treatment
options, ii) the results of the alfapump POSEIDON
and Patient Preference studies, and what this means for US patients
and physicians, and iii) alfapump US commercial
roll-out plans and market opportunity.
A live question and answer session will follow
the formal presentation.
Webinar Details
- Wednesday,
January 8th, 2025, at 15:00 CET / 09:00 EST
- Registration
webcast: please click here
- Registration
conference call (if you wish only to participate in the Q&A):
please click here. Once registered, you will receive dial-in
numbers and a confirmation code.
The webcast and conference call will be
conducted in English and a replay will be available on Sequana
Medical’s website shortly after.
Dr. Saab, MD, MPH is a
Professor in the Departments of Medicine and Surgery at the David
Geffen School of Medicine at UCLA (University of California Los
Angeles) and an Adjunct Professor of Nursing at the UCLA School of
Nursing. He is currently the Medical Director of the UCLA Adult
Liver Transplant Program, Medical Director of the Pfleger Liver
Institute, and the Chief of Transplant Hepatology. Dr Saab is also
the Head of Outcomes Research in Hepatology. He has been on the
faculty at UCLA for over two decades. Dr. Saab is board certified
in transplant hepatology. He has received honorary fellowships from
the American Gastroenterology Association (AGAF), American College
of Gastroenterology (FACG) and the American Association for the
Study of Liver Diseases (FAASLD).
Dr. Pagadala, MD is Liver
Transplant Hepatology and Director of the Hepatology
Research Liver Institute – Methodist Dallas Medical Center,
Assistant Professor – TCU and UNT School of Medicine. He
completed his internal medicine residency at North Shore Medical
Center at Salem Hospital in Salem, Massachusetts, and his
gastroenterology, hepatology, and transplant hepatology fellowship
at Cleveland Clinic in Cleveland, Ohio. He specializes in the
treatment of advanced fibrosis in nonalcoholic fatty liver disease,
nonalcoholic steatohepatitis, viral hepatitis, complications of
portal hypertension and cirrhosis, hepatocellular carcinoma, adult
liver transplantation, and other gastrointestinal disorders. He is
an active member of the American College of Gastroenterology and
American Association for the Study of Liver Diseases.
He is an active member of the American Association for the Study of
Liver Diseases (AASLD) and of the American College of
Gastroenterology.
For more information, please
contact:Sequana Medical Investor
relationsE: IR@sequanamedical.com T: +44 (0) 797 342 9917
Optimum Strategic
CommunicationsNick Bastin, Vici Rabbetts, Elena BatesE:
Sequana@optimumcomms.comT: +44 (0) 208 078 4357
About alfapump in recurrent or
refractory ascites due to liver cirrhosis & the POSEIDON
studyRecurrent or refractory ascites is a severe condition
characterized by the accumulation of fluid in the abdomen. The
current standard treatment involves therapeutic paracentesis, an
invasive and burdensome procedure that drains ascites from the
abdomen using a large needle over an extended period. The
alfapump is approved by the US FDA for the
treatment of recurrent or refractory ascites due to liver
cirrhosis. It is the first active implantable medical device in the
US that automatically and continuously removes ascites from the
abdomen into the bladder, where it is naturally eliminated through
urination. To date, over 1,000
alfapump systems have been implanted.
The US market of recurrent and refractory
ascites due to liver cirrhosis is forecast to grow by an average of
9% per year, from approximately 70,000 patients in 2025 to 130,000
patients by 2032, primarily driven by the increasing prevalence of
NASH / MASH2. The total market opportunity for
alfapump is estimated at over $2 billion in 2025,
including approximately $500 million from the Company’s initial
priority target market of patients requiring at least 12
paracenteses per year.
The FDA’s approval of the PMA is based on the
successful execution of Sequana Medical’s pivotal POSEIDON study, a
landmark study across 18 centers in the US and Canada with a total
of 69 patients implanted with the alfapump. The
primary effectiveness endpoints at six months post-implantation in
the Pivotal Cohort3 exceeded the predefined thresholds with
statistical significance, and primary safety endpoint data was in
line with expectations4. Data at 12 months post-implantation
continued to show a strong and durable clinical profile, virtually
eliminating the need for therapeutic paracentesis and delivering an
improvement in quality of life (as defined by subjective physical
health (assessed by SF-36 PCS) and ascites symptoms (assessed by
Ascites Q))5. At AASLD’s The Liver Meeting in November 2024, key
POSEIDON investigators reported that the alfapump
virtually eliminated the need for large volume paracentesis at 24
months, with overall survival of 62%6.
Data from the patient preference study and a
matched cohort analysis of the NACSELD-III registry with the
POSEIDON Pivotal Cohort indicated that US patients have a strong
preference for the alfapump vs standard
paracentesis procedures and that the safety profile of the
alfapump is comparable to standard of care.7
About Sequana Medical
Sequana Medical NV is a pioneer in treating
fluid overload, a serious and frequent clinical complication in
patients with liver disease, heart failure and cancer. This causes
major medical issues including increased mortality, repeated
hospitalizations, severe pain, difficulty breathing and restricted
mobility. Although diuretics are standard of care, they become
ineffective, intolerable or exacerbate the problem in many
patients. There are limited effective treatment options, resulting
in poor clinical outcomes, high costs and a major impact on their
quality of life. Sequana Medical is seeking to provide innovative
treatment options for this large and growing "diuretic resistant"
patient population. alfapump® and DSR® are Sequana
Medical's proprietary platforms that work with the body to treat
diuretic-resistant fluid overload, and are intended to deliver
major clinical and quality of life benefits for patients, while
reducing costs for healthcare systems.
The Company received US FDA approval for the
alfapump System for the treatment of recurrent or
refractory ascites due to liver cirrhosis in December 2024,
following the grant of FDA Breakthrough Device Designation in
2019.
Results of the Company's RED DESERT and SAHARA
proof-of-concept studies in heart failure published in European
Journal of Heart Failure in April 2024 support DSR's mechanism of
action as breaking the vicious cycle of cardiorenal syndrome. All
three patients from the non-randomized cohort of MOJAVE, a US
randomized controlled multi-center Phase 1/2a clinical study, have
been successfully treated with DSR, resulting in a dramatic
improvement in diuretic response and virtual elimination of loop
diuretic requirements8. The independent Data Safety Monitoring
Board approved the start of the randomized MOJAVE cohort of up to a
further 30 patients, which is planned after
alfapump US PMA approval.
Sequana Medical is listed on the regulated
market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in
Ghent, Belgium. For further information, please visit
www.sequanamedical.com.
Indication for Use: The
alfapump® System is intended for single patient
use only in adult patients with refractory or recurrent ascites due
to liver cirrhosis. It is indicated for the removal of excess
peritoneal fluid from the peritoneal cavity into the bladder, where
it can be eliminated through normal urination.
Contraindications: The
alfapump® System is MRI unsafe. Hyperbaric oxygen
therapy is contraindicated.
Warnings, Risks, and
Precautions: Consider risks associated with implanting the
alfapump® System including risk of peritoneal
cavity infections, Coagulopathy, Small bladder capacity and/or
obstructive uropathy. The following procedures or therapies could
impact the alfapump® System function: Supersonic
therapy and high-frequency heat therapy, Transcutaneous Electrical
Nerve Stimulation (TENS), Lithotripsy, Defibrillation, Radiation
therapy, Electrocautery, or use of other implantable medical
devices and wearable devices.
Adverse Events: In addition to
procedure related risks the following Adverse Events may occur:
pump pocket hematoma, skin erosion, infection, pump migration,
catheter clogging or other catheter complications resulting in
tissue damage or loss of or change in therapy, genito-urinary
complications, reduced kidney function, hepatic encephalopathy,
progression of liver disease, and other systemic effects.
P230044 PMA approval letter on file
U.S. Federal law restricts
alfapump System to sale by or on the order of a
physician.
The alfapump® System is
currently not approved in Canada.
DSR® therapy is still in development and is
currently not approved in any country. The safety and
effectiveness of DSR® therapy has not been established.
Note: alfapump® and DSR® are
registered trademarks.
Forward-looking statements
This press release may contain predictions,
estimates or other information that might be considered
forward-looking statements. Such forward-looking statements are not
guarantees of future performance. These forward-looking statements
represent the current judgment of Sequana Medical on what the
future holds, and are subject to risks and uncertainties that could
cause actual results to differ materially. Sequana Medical
expressly disclaims any obligation or undertaking to release any
updates or revisions to any forward-looking statements in this
press release, except if specifically required to do so by law or
regulation. You should not place undue reliance on forward-looking
statements, which reflect the opinions of Sequana Medical only as
of the date of this press release.
1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P2300442
Based on US market assessment conducted by highly experienced
international consulting group3 The Pivotal Cohort is used for the
primary effectiveness endpoints and consists of 40 patients
implanted with the alfapump4 Data reported in
press release of 25 October 2022 5 Data reported in press release
of 19 October 20236 Based upon the pivotal cohort of the POSEIDON
study, data reported in press release of 18 November 20247 Data
reported in press release of 19 October 2023; Patient Preference
study conducted by RTI Health Solutions, and matched cohort
analysis presented by Dr. Bajaj at EASL Congress 2024.8 Data
reported in press release of 25 March 2024; mean increase of 326%
in six-hour urinary sodium excretion at 3 months follow up vs
baseline, and 95% reduction of loop diuretics over same period
- 250106 Press release KOL call reminder (ENG)
- 250106 Press release KOL call reminder (NL)
