Allurion has completed patient enrolment in its pivotal trial designed to produce the necessary data for US Food and Drug Administration (FDA) approval of its weight-loss balloon.

Allurion’s AUDACITY trial (NCT05368259) enrolled 550 patients with a body mass index between 30kg/m² and 40kg/m² and who have have unsuccessfully attempted weight loss. The prospective, open-label, multi-centre, randomised, pivotal study compared weight loss in patients across 17 sites who received the balloon and lifestyle therapy with those who only went through lifestyle therapy.

According to the Massachusetts, US-based company, nearly 40,000 people completed a pre-screen questionnaire on the website for the trial.

Allurion’s gastric balloon has been available in Europe since it received CE marking in 2015. The company is also eyeing the Middle Eastern and African markets after it entered a sales agency agreement with Medtronic, which is also an investor in Allurion.

The popularity of its balloon has also led to the company going public in February 2023 after it signed an agreement with special purpose acquisition company (SPAC) Compute Health. Allurion has a market cap of $216.5m as of October 2023.

A market model by GlobalData estimates that bariatric surgery devices across the EU5 market will be worth $21.4m by 2025.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Alluroin’s balloon is swallowed as a capsule and then filled with liquid. From here, it acts like a traditional gastric balloon that promotes weight loss by mimicking a full stomach. Allurion’s balloon, unlike other approaches, does not require surgery, endoscopy or anaesthesia. After around four months, the balloon releases the liquid on its own and it passes out of the body naturally.  

Dr Ram Chuttani, Allurion chief medical officer, said: “We are delighted to bring the Allurion Balloon one step closer to commercialisation in the United States. We are looking forward to building off the experience we have acquired in treating over 130,000 patients outside of the United States.”