US-based Allurion Technologies has raised $34m in a funding round led by Novalis LifeSciences and Romulus Capital.
IDO Investments and ex-Covidien CEO, Jose Almeida also joined the funding round.
The medical device firm intends to use the proceeds to expand its international footprint and launch its weight loss programme in the US, subject to receipt of FDA permission.
The funding also encompasses a growth capital term loan from Bridge Bank.
In 2018, Allurion completed enrollment for its US clinical trial for weight loss program ENLIGHTEN.
The company expects to submit its pre-market approval (PMA) application to the FDA next year.
The company’s Elipse Program comprises Elipse Balloon, a procedureless medical device for weight loss, as well as a Bluetooth body composition scale.
Elipse Balloon is made of thin, flexible polymer film and is delivered in a swallowable capsule, reducing the need for surgery, endoscopy, or anaesthesia.
It is swallowed in a capsule in a doctor’s office and to remain in the patients’ stomach for four months before being eliminated naturally.
The device is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached.
Allurion co-founder and CEO Shantanu Gaur said: “We have experienced exponential growth over the past three years and with two billion people around the world who are overweight, we expect our rapid ascent to continue.
“We believe that our focus on a 360-degree consumer experience that delivers life-changing results has differentiated us from the competition and driven unprecedented demand. As a result, Allurion is now the leader in a new category with massive potential.”
In 2015, Allurion Technologies received the marketing approval in Europe for Elipse gastric balloon.
The device is not approved by the US Food and Drug Administration (FDA) at this time and is not available for sale in the US.