Allurion files PMA submission of Elipse Gastric Balloon with FDA
Allurion Technologies is one step closer to having its Elipse gastric balloon enter the US market, after company announced the PMA submission of the device to the FDA. The submission comes after Allurion raised US$34 million in new funding through a securities financing and a growth capital term loan.
Allurion’s weight loss programme features the Elipse Balloon - the world’s first and only procedureless medical device for weight loss. According to the company, unlike other weight loss balloons on the market the Elipse Balloon is designed to be placed and removed without surgery, endoscopy or anaesthesia. It is swallowed in a capsule during an outpatient office visit and is designed to remain in the stomach for approximately four months, after which it opens and passes naturally from the body.
Allurion has already treated over 20,000 patients in over 30 countries across the world outside the US. In one of the largest balloon weight loss studies ever conducted overseas, the Elipse Program resulted in nearly 30lbs of weight loss on average across 1,623 patients.
"Allurion is looking forward to entering the US market where the burden of obesity continues to grow,” said Executive Vice President of Global Commercial, Benoit Chardon. “The investments we have made in expanding our global business and preparing for US launch underscore our commitment to tackling the obesity epidemic all around the world."
As the company prepares for entrance into the US market in late 2020, it has filled a key executive position in regulatory affairs and quality assurance with the addition of Joyce Johnson as Vice President. At Allurion, Johnson will oversee all global compliance and product submission activities as the company expands its offerings and enters new global markets. She will be the company’s primary regulatory contact with the FDA for ongoing approval discussions and assume responsibilities with existing global regulatory bodies.
“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 Dr Shantanu Gaur, 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.”
Johnson comes to Allurion with over 25 years of experience in the medical device industry where she has held key positions in global compliance and product registration. Most recently, she held the position of Vice President, Regulatory and Quality at SpaceLabs. Prior to SpaceLabs, Johnson served in several Vice President capacities at Smith & Nephew, Analogic and Draeger.
Elipse could be available in the US market in late 2020, the company stated.