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.

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By GlobalData

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.”