Allurion Announces Submission of First Three Modules of Premarket Approval Application to the U.S. Food and Drug Administration for the Allurion Balloon
23 10월 2024 - 9:00PM
Business Wire
Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to
ending obesity, today announced the submission of the first three
modules of its premarket approval application (PMA) to the U.S.
Food and Drug Administration (FDA) for the Allurion Balloon. The
Company expects to file the fourth and final module of the PMA
containing the clinical data from its AUDACITY trial early next
year.
"These submissions are a critical milestone for Allurion, and I
commend our team for their efforts," said Dr. Shantanu Gaur,
Allurion’s Founder and CEO. "We are pleased to capitalize on the
opportunity that the FDA provides through its modular submission
program to improve the efficiency of our application process."
In a traditional PMA application, the applicant submits all PMA
data at the same time, and the FDA begins its PMA review only upon
receipt of all of the required information. In a modular PMA
application, the FDA allows applicants to submit discrete sections
of the application for review to improve the efficiency of the
process.
The Allurion Gastric Balloon is the world’s first and only
swallowable, procedureless™ gastric balloon for weight loss and was
designed to address various shortcomings of legacy gastric
balloons. It is swallowed as a capsule and placed under the
guidance of a health care provider without surgery, endoscopy, or
anesthesia. The placement takes approximately 15 minutes during an
outpatient visit. Approximately four months later, a patented
ReleaseValve™ opens, allowing the balloon to empty and pass out of
the body naturally1. Over 150,000 patients have already been
treated with the Allurion Balloon outside the United States.
The Allurion Balloon is being evaluated in AUDACITY, a
randomized, pivotal controlled trial in 550 patients at 17 sites in
the United States. The trial completed enrollment in the fall of
2023, two months ahead of schedule. The company expects the trial
to conclude by the end of 2024.
Source: 1. Jense, M.T., Palm-Meinders, I.H., Sanders, B. et al. The
Swallowable Intragastric Balloon Combined with Lifestyle Coaching:
Short-Term Results of a Safe and Effective Weight Loss Treatment
for People Living with Overweight and Obesity. OBES SURG 33,
1668–1675 (2023). https://doi.org/10.1007/s11695-023-06573-8
About Allurion
Allurion is dedicated to ending obesity. The Allurion Program is
a weight loss platform that features the Allurion Gastric Balloon,
the world’s first and only swallowable, Procedure-less™
intragastric balloon for weight loss, and offers access to the
Allurion Virtual Care Suite, including the Allurion Mobile App for
consumers, Allurion Insights for health care providers featuring
the Coach Iris AI Platform, and the Allurion Connected Scale. The
Allurion Virtual Care Suite is also available to providers
separately from the Allurion Program to help customize, monitor and
manage weight loss therapy for patients regardless of their
treatment plan: gastric balloon, surgical, medical or nutritional.
The Allurion Gastric Balloon is an investigational device in the
United States.
For more information about Allurion and the Allurion Virtual
Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc. in the
United States and countries around the world.
Forward-Looking Statements
This press release may contain certain forward-looking
statements within the meaning of the U.S. federal and state
securities laws. These forward-looking statements generally are
identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions and
include statements regarding the completion of the Company’s
AUDACITY trial and submission of the company’s PMA following data
readout. Forward-looking statements are predictions, projections
and other statements about future events that reflect the current
beliefs and assumptions of Allurion’s management based on
information currently available to them and, as a result, are
subject to risks and uncertainties. Many factors could cause actual
future results or developments to differ materially from the
forward-looking statements in this communication, including but not
limited to (i) the ability of Allurion to obtain and maintain
regulatory approvals for and successfully commercialize the
Allurion Program, including the Allurion Balloon and the VCS, in
the United States and abroad, (ii) the timing of, and results from,
our clinical studies and trials and submission of such results to
regulatory authorities, (iii) the evolution of the markets in which
Allurion competes, (iv) the ability of Allurion to defend its
intellectual property, (v) the impact of the COVID-19 pandemic, the
Russia and Ukraine war, and the conflict in the Middle East on
Allurion’s business, (vi) Allurion’s expectations regarding its
market opportunities, including those for the Allurion Program and
VCS platform, and (vii) the risk of economic downturns and a
changing regulatory landscape in the highly competitive industry in
which Allurion operates. The foregoing list of factors is not
exhaustive. You should carefully consider the foregoing factors and
the other risks and uncertainties described in the “Risk Factors”
section of Allurion’s Annual Report on Form 10-K filed on March 26,
2024 (as subsequently amended) and other documents filed by
Allurion from time to time with the U.S. Securities and Exchange
Commission. These filings identify and address other important
risks and uncertainties that could cause actual events and results
to differ materially from those contained in the forward-looking
statements. Forward-looking statements speak only as of the date
they are made. Readers are cautioned not to put undue reliance on
forward-looking statements, and Allurion assumes no obligation and
does not intend to update or revise these forward-looking
statements, whether as a result of new information, future events,
or otherwise. Allurion does not give any assurance that it will
achieve its expectations.
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version on businesswire.com: https://www.businesswire.com/news/home/20241023889366/en/
Global Media Cedric Damour PR Manager +33 7 84 21 02 20
cdamour@allurion.com
Investor Contact Mike Cavanaugh, Investor Relations ICR
Westwicke (617) 877-9641 mike.cavanaugh@westwicke.com
Allurion Technologies (NYSE:ALUR)
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부터 10월(10) 2024 으로 11월(11) 2024
Allurion Technologies (NYSE:ALUR)
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