Upstart wins CE mark for first swallowable weight-loss gastric balloon
|Elipse Gastric Balloon--Courtesy of Allurion Technologies|
A couple of gastric balloon weight loss products were approved by the FDA earlier this year, greatly expanding the available device options for obese patients. Now, the latest iteration of a gastric balloon has been given the go-ahead in the EU, and it doesn't require endoscopic placement like those already available in the U.S.
Dubbed the Elipse Gastric Balloon and developed by Allurion Technologies, it is delivered via a capsule that is swallowed and subsequently inflated via an attached line that then disconnects and is removed. After four months of use, the balloon automatically deflates and then is excreted from the body.
"Excess weight often has a profound impact on health and quality of life including work, relationships and self-perception, said Allurion co-founder and CSO Dr. Shantanu Gaur said in a statement. "Weight loss therapies that require surgery, endoscopy, or anesthesia are often too invasive and can be too expensive for people who might otherwise greatly benefit from them."
Added Allurion co-founder and President Dr. Samuel Levy, "Our procedureless gastric balloon offers a simple, safe and effective alternative." There are almost 2 billion obese people globally with less than 1% of that eligible population taking advantage of surgical or endoscopic options, the company noted.
Allurion was co-founded in 2009 by Gaur and Levy, then second-year Harvard Medical School students. The following year, Allurion brought on Jonathan Wecker as CEO--he was previously the CEO of the American Institute of Gastric Banding, the largest Lap-Band weight loss surgery center in the United States.
The Wellesley, MA-based startup has raised very little money to get it this far, according to SEC filings: less than $5 million. It is funded by undisclosed private investors and the Massachusetts Life Sciences Center. The most recent infusion of $1.6 million came last year from 21 investors.
But if Allurion is aiming for FDA approval next, it seems likely to need a lot more cash soon to support studies sizeable enough for an FDA approval. In addition, it will need to fund European commercialization efforts. The startup said its Elipse device will be available initially in select weight-loss centers in France, Italy and the United Kingdom.
A handful of weight-loss device options are approved in the U.S. The Lap-Band is marketed by Apollo Endosurgery, which also has its Orbera Intergastric Balloon weight-loss device that was approved in the U.S. in August. The ReShape Integrated Dual Balloon System was also approved this year. Unlike Orbera, however, the ReShape approved indication includes one or more co-morbidities in addition to the requirement of a body mass index 30-40 kg/m2 that applies to both of these balloon systems.
In a study of Elipse, 34 patients with a BMI of 27-40 kg/m2 had lost an average of 10 kilograms (22 pounds) during the four-month treatment period, with participants losing an average of 37% of their excess weight and 8 cm off their waist circumference.
Patients also had improvements in levels of triglycerides and hemoglobin A1c (HbA1c) as well as all quality of life. All of the balloons in the trial were excreted safely. These interim data were recently presented at the annual conference for the American Society for Metabolic and Bariatric Surgery and The Obesity Society.
"Following 6 years of development, we are very excited to enter the next phase of our company's growth," said Allurion CEO Wecker. "Following initial release in Europe, we expect to offer Elipse in the Middle East and beyond in the months and years to come."
- here is the announcement
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