Allurion Completes Enrollment in Pivotal AUDACITY Trial for the Allurion Balloon
October 11 2023 - 8:00AM
Business Wire
AUDACITY trial to support FDA approval of the
Allurion Balloon
Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to
ending obesity, today announced the completion of patient
enrollment in its AUDACITY trial. AUDACITY is a randomized, pivotal
controlled trial designed to support U.S. Food and Drug
Administration (FDA) approval of the Allurion Balloon. The trial
enrolled 550 patients at 17 sites and completed enrollment two
months ahead of schedule.
“I believe the brisk enrollment in the AUDACITY trial reflects
the broad appeal of a novel, completely reversible weight loss
device,” said Shelby Sullivan, M.D., Director of the
Gastroenterology Metabolic and Bariatric Program at the University
of Colorado School of Medicine and Principal Investigator of the
AUDACITY trial. “As the obesity epidemic worsens in the United
States, I expect options like the Allurion Balloon will be
attractive to a large segment of the population.”
The AUDACITY trial website received 78,106 unique visitors of
whom over half or 39,947 completed a pre-screen questionnaire.
“We were pleased to see such a high level of interest in the
Allurion Balloon in the United States,” said Jay Donosky, Vice
President of Clinical Affairs for Allurion. “As interest in weight
loss grows in the United States with the rise of GLP-1 drug
therapy, we believe our robust enrollment is indicative of a strong
desire for alternative first-line options.”
The Allurion Balloon is the world’s first and only swallowable,
procedure-less gastric balloon for weight loss and was designed to
address various shortcomings of legacy gastric balloons. It is
swallowed as a capsule and filled 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
naturally. The patient does not need to return to the doctor to
have the balloon removed.
“We are delighted to bring the Allurion Balloon one step closer
to commercialization in the United States,” said Dr. Ram Chuttani,
Chief Medical Officer for Allurion. “We are looking forward to
building off the experience we have acquired in treating over
130,000 patients outside of the United States.”
About Allurion
Allurion is dedicated to ending obesity. The Allurion Program is
a weight-loss platform that combines the Allurion Gastric Balloon,
the world’s first and only swallowable, procedure-less gastric
balloon for weight loss, the Allurion Virtual Care Suite, including
the Allurion Mobile App for consumers, Allurion Insights for
healthcare providers featuring the Iris AI Platform, and the
Allurion Connected Scale and Health Tracker devices. 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, whether it is 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.
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 Allurion’s expectations for, and
market acceptance of, the Allurion Program. 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 regulatory approval for and successfully
commercialize the Allurion Program, (ii) the results of clinical
data from its studies, (iii) the evolution of the markets in which
Allurion competes, (iv) the ability of Allurion to defend its
intellectual property and satisfy regulatory requirements, (v) the
impact of the COVID-19 pandemic on Allurion’s business, (vi)
Allurion’s expectations regarding its market opportunities 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 the
proxy statement/prospectus contained in Allurion’s Registration
Statement on Form S-4 (333-271862), the company’s Form 8-K filed on
August 7, 2023 (as 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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US Media Brian Ruby ICR 203-682-8268
brian.ruby@icrinc.com
Global Media Cedric Damour PR Manager +33 7 84 21 02 20
cdamour@allurion.com
Investors Mike Cavanaugh ICR Westwicke 617-877-9641
mike.cavanaugh@westwicke.com
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