PRESS RELEASE: REGULATED
INFORMATION – INSIDE INFORMATION 22 MAY 2024,
07:00 CEST
Sequana Medical announces positive
outcome of Day 100 meeting with FDA regarding PMA application for
alfapump®
Positive and collaborative meeting with
FDA
PMA substantive review complete; No
further new questions on clinical or pre-clinical data
FDA Advisory Panel no longer
expected
FDA Marketing Approval now anticipated in
Q1 2025
Planned US commercial launch remains H2
2025
Ghent, Belgium – 22 May 2024
– Sequana Medical NV (Euronext Brussels: SEQUA)
(the "Company" or "Sequana
Medical"), a pioneer in the treatment of fluid
overload in liver disease, heart failure and cancer, today
announces the agreed outcome of the “Day 100” meetingi with the US
Food and Drug Administration (FDA), following receipt of the “Day
90” major deficiency Letter. The alfapump is the
Company’s fully implantable, wirelessly charged device for patients
with recurrent or refractory ascites due to liver cirrhosis and
received breakthrough device designation from the US FDA in
2019.
The PMA application for the
alfapump system, which was based on the successful
execution of Sequana Medical’s pivotal POSEIDON study, was accepted
for substantive review on 29 January 2024. Following a review of
this application by the FDA, the Company received a “Day 90” major
deficiency letter and a “Day 100” meeting was held with FDA to
align on key findings. The FDA confirmed completion of the
substantive review and no further new questions on the clinical
study or the pre-clinical data, unless related to the Company’s
response to the “Day 90” Letter. The FDA had a number of
non-clinical questions that require additional work and the Company
currently anticipates to submit this additional information by the
end of September 2024. In light of the FDA’s feedback and the
rapidly evolving cybersecurity environment, the Company intends to
exclude RPMS/DirectLink (the software for remote uploading of
performance data from the alfapump) from the PMA application and
the initial alfapump commercialisation, and to
submit a next-generation version in a PMA supplement
post-approval.
The Company now forecasts FDA approval before
the end of Q1 2025, with no change to the planned US commercial
launch in H2 2025. The Company continues to evaluate its financing
options to achieve FDA approval and prepare for commercial launch
of the alfapump.
Timur Resch, Global Vice President
QM/QA/RA at Sequana Medical, commented: “The receipt of
the PMA Day 90 letter and completion of the Day 100 meeting is
another huge milestone for Sequana, and reflects the significant
amount of work by the team for the preparation of the marketing
application. We appreciate the positive interaction with the FDA
and believe that the outstanding questions are manageable. We
intend to complete these activities in time for a response to the
FDA by the end of Q3 this year.”
Ian Crosbie, Chief Executive Officer of
Sequana Medical, commented: “We are very pleased with the
progress of our alfapump PMA application and
grateful for the collaborative nature of discussions with the FDA
for our breakthrough device. The completion of the substantive
review and confirmation there will be no further new questions
related to the clinical study data or pre-clinical data, unless
related to our responses, is a very important event for us,
providing clarity on the approval path forward and derisking the
alfapump program. We look forward to addressing
the remaining questions from FDA and anticipate approval before the
end of Q1 2025.”
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For more information, please
contact:
Sequana Medical
Ian Crosbie, CEO
E: IR@sequanamedical.com T: +44 7973 42 99
17
About alfapump in recurrent or
refractory ascites due to liver cirrhosis
Recurrent 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. If approved by the FDA, the alfapump could
become 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.
The PMA application submitted to the US FDA was
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 Cohortii exceeded the
predefined thresholds with statistical significance, and primary
safety endpoint data was in line with expectationsiii. Data at 12
months post-implantation continued to show a strong and durable
clinical profile, virtually eliminating the need for therapeutic
paracentesis and delivering a clinically meaningful improvement in
patients’ quality of lifeiv.
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.
The North American market of recurrent and
refractory ascites due to liver cirrhosis is forecast to grow on
average 9% per year, from approximately 78,000 patients in 2025
reaching 147,000 patients by 2032, primarily driven by the
increasing prevalence of NASHv. The total market opportunity for
alfapump is estimated at $2.4 billion in 2025,
including approximately $600 million from the Company’s initial
priority market targeting patients requiring at least 12 paracentes
per year. To date, over 1,000 alfapump systems
have been implanted.
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, untolerable 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, delivering major clinical and
quality of life benefits for patients and reducing costs for
healthcare systems.
The Company's Premarket Approval (PMA)
application for the alfapump was submitted to the
US FDA in December 2023 and accepted for substantive review in
January 2024, having reported positive primary and secondary
endpoint data from the North American pivotal POSEIDON study in
recurrent or refractory ascites due to liver cirrhosis. US market
approval of the alfapump is anticipated before the
end of Q1 2025 with US commercial launch planned for H2 2025.
Results of the Company's RED DESERT and SAHARA
proof-of-concept studies in heart failure 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 requirements. 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.
Important Regulatory
Disclaimers
The alfapump® system is
currently not approved in the United States or Canada. In the
United States and Canada, the alfapump system is
currently under clinical investigation (POSEIDON Trial) and is
being studied in adult patients with refractory or recurrent
ascites due to liver cirrhosis. DSR® therapy is still in
development and it should be noted that any statements regarding
safety and efficacy arise from ongoing pre-clinical and clinical
investigations which have yet to be completed. There is no link
between DSR therapy and ongoing investigations with the
alfapump system in Europe, the United States or
Canada.
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.
i A PMA applicant may request a Day 100 Meeting to discuss the
review status of their PMA. FDA will inform the applicant of any
identified deficiencies prior to the meeting, which will take place
no later than 100 days after the receipt of the PMA application.
Source: www.fda.gov, last consulted on 17 May 2024ii The Pivotal
Cohort is used for the primary effectiveness endpoints and consists
of 40 patients implanted with the alfapumpiii Data
reported in press release of 25 October 2022iv Data reported in
press release of 19 October 2023v Based on US and Canada market
assessment conducted by highly experienced international consulting
group
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