Allurion Technologies is hoping to be able to get FDA approval to launch its obesity treatment balloon in 2020. The Natick, MA-based company said it was making progress toward its goal of getting Elipse on the U.S market by completing enrollment in the ENLIGHTEN clinical trial. The company exceeded its 400-patient target for the clinical study.

“The reason we exceeded our target was because of the unprecedented demand that we experienced for the trial,” Shantanu Gaur, co-founder and CEO of Allurion, told MD+DI. “It was really astonishing to see the traffic numbers at our study website. All over the country people were clamoring to be a part of ENLIGHTEN. The response is supportive of our vision that [Elipse] isn’t just a balloon, but a frictionless weight loss experience that seems to appeal to both consumers and physicians.”

Topline results from ELIGHTEN are estimated to be available in 2019.

Allurion received CE mark for Elipse in 2015 and has treated more than 6,000 patients with the device. The company went on to say that the technology has been used in 100 weight loss centers in countries across Europe and the Middle East.

The Elipse Balloon is made of a thin, flexible polymer film. The device is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached. The balloon remains in the stomach for about four months, after which it opens, allowing it to empty and pass naturally from the body without the need for a removal procedure.

The technology treats patients with body mass index between 30 and 40.

“The Elipse balloon is the world’s first and only procedure less product,” Gaur said. “It is delivered without endoscopy; without anesthesia; and without surgery – free of medical complexity.”

In 2015, MD+DI named Allurion Technologies as one of the 5 top obesity startups in medtech. The company went relatively untouched during the massive consolidation of the obesity treatment space that took place over the past few years.

One of the most notable merger attempts came when EnteroMedics acquired ReShape Medical in a cash a stock deal worth $38 million. St. Paul, MN-based EnteroMedics would eventually change its name to ReShape Lifesciences. The company has approval of the Dual Weight Loss Balloon. The ReShape deal made MD+DI’s list of the top seven key moments that transformed the obesity treatment market.

Gaur said many of the players in the obesity treatment market are missing the market because they are focused on a reimbursement model as opposed to a consumer-based model.

“The successful products or the successful experiences in the weight loss space are going to be the ones that are designed with the consumer's best interest in mind,” Gaur said. “A lot of the big strategics and a lot of the companies in our space are working in a reimbursement frame of mind, but they should be working inside a consumer-facing cash pay frame of mind.”

Typically, obesity treatment devices are not reimbursed by Centers for Medicare and Medicaid Services. Instead, patients usually pay for treatment with these devices on their own.

“We knew from day one that consumers were going to pay out of pocket for this weight-loss experience,” Gaur said. “That has driven a lot of the development and research that we’ve done in the past nine years. We wanted to create an experience free of medical complexity so that it could be made available more affordably. When consumers are reaching into their pockets and putting this type of product or experience on a credit card – price matters.”