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Allurion Files for PMA Submission of Elipse Gastric Balloon

The Natick, MA-based company has also hired a VP of Regulatory Affairs and Quality Assurance to help it in its bid to get the weight-loss device to the market. The measure comes hot on the heels of Allurion raising $34 million in new funding.

Allurion Technologies is one step closer to having its Elipse gastric balloon enter the U.S. market. The Natick, MA-based company announced the PMA submission of the device early Tuesday.

The submission comes hot on the heels of Allurion raising $34 million in new funding through a securities financing and a growth capital term loan. Allurion also announced the hiring of Joyce Johnson as VP, Regulatory Affairs and Quality Assurance.

“Joyce comes to Allurion at an opportune and exciting time as we work towards receiving US regulatory approval from the FDA for the Elipse Balloon,” said Shantanu Gaur, M.D., co-founder and Chief Executive Officer of Allurion. “Her track record of success and leadership in the areas of compliance and quality assurance will prove valuable as we continue to rapidly scale the business.”

The company said unlike other weight loss balloons on the market, the Elipse Balloon is designed to be placed and removed without surgery, endoscopy, or anesthesia. It is swallowed in a capsule during an outpatient office visit and is designed to remain in the stomach for about four months, after which it opens and passes naturally from the body.

Elipse could be available in the U.S. market in late 2020, the company said in a release.

While Allurion is making progress, Obalon Therapeutics, one of its competitors, is exploring strategic options because of the negative impact of the coronavirus (COVID-19) on elective procedures.

Late last month, the weight loss specialist said these alternatives could include equity or debt financing; a sale of the company; a business combination; or a merger or a reverse merger with another party.

Obalon has developed a gas-filled intragastric balloon system that treats obesity. The device won a nod from FDA back in 2016. A little more than a year ago, the company released its direct sales force and began marketing the device through special centers.

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