|Elipse Gastric Balloon--Courtesy of Allurion Technologies|
The market for intragastric balloons to enable weight loss is just getting started in the U.S. after a pair of FDA approvals last summer for the first devices in this category--although it's been in full swing in Europe for years. The FDA-approved options are placed and removed endoscopically--but the newest iteration is an ingestible device that is filled with liquid after it's ingested into the stomach.
"The medical community has been looking for innovative tools like Elipse to aid in the fight against overweight and obesity. Without the cost and invasiveness of surgery, endoscopy and anesthesia, this new option vastly expands access to intragastric balloons," said Allurion CEO Jonathan Wecker.
The procedureless, intragastric balloon is from startup Allurion, which has now raised $6 million to back its EU and Middle East marketing of the Elipse balloon. The weight-loss device received a CE mark late last year and is already marketed in the U.K., France and Italy, with a Middle East launch coming up soon. Romulus Capital led the financing.
Allurion is in talks with the FDA, with a U.S. pivotal trial slated for next year--although it will surely need to raise a subsequent, much larger sum to support what would almost certainly need to be a sizable study.
Allurion's Elipse is swallowed in a capsule and then filled with liquid via a thin delivery catheter, which is then detached. It remains in the stomach for about four months--after which the balloon opens to empty and pass from the body.
In a study in people with a BMI between 27 and 40, treated patients lost an average of 22 pounds--or 39% of their excess weight. They also lost an average of 8 centimeters in waist circumference as well saw improvements in triglycerides, hemoglobin A1c (HbA1c) and quality of life.
"Since the day Allurion was founded, we have sought to create a product that is safe and effective for consumers and is straightforward for physicians to use," said co-founder and CSO Dr. Shantanu Gaur. "We are very pleased to see those design principles come to fruition in our commercial launch."