Allurion Technologies has obtained another $34 million in funding as the venture-backed Natick startup prepares to seek US approval this year for its medical device to help people lose weight.
The sum includes $20 million in venture capital from investors such as New Hampshire-based Novalis LifeSciences and Boston-based Romulus Capital. It also includes a $14 million growth capital term loan from Bridge Bank that Allurion’s chief executive said was a vote of confidence in its product, a polyurethane balloon that stays in a patient’s stomach for four months.
“This funding allows us to continue growing at a very fast pace,” said Dr. Shantanu Gaur, the chief executive, who cofounded Allurion in 2009 with a fellow Harvard Medical School graduate after they realized that obesity was the common denominator in many diseases.
Allurion grew to 100 employees from 60 last year and invested $1.5 million in a new manufacturing plant in Natick. Its device has already won approval in Europe, the Middle East, Latin America, and Asia, and the company has sold 20,000 of them in 25 countries since 2016.
The product, called the Elipse Balloon, is part of a wave of medical devices that have been developed in the Boston area and elsewhere to combat the worsening obesity epidemic.
During a 20-minute office visit to the doctor, a patient swallows a large capsule that contains a deflated polyurethane balloon attached to a thin catheter. The doctor then fills the balloon with about 2½ cups of water and pulls the catheter out of the patient’s mouth.
The balloon sits in the stomach for four months, curbing appetite. Then it collapses and leaves the body the old-fashioned way.
In one of the largest gastric balloon data sets ever collected, 1,623 patients across 19 weight loss centers in seven countries lost, on average, 28 pounds after swallowing the Elipse, according to Allurion.
The company has tested the device on 416 patients in the United States and plans to seek clearance by the Food and Drug Administration this year based on the results, Gaur said.
If the FDA approves the device, a patient would have to pay about $4,000 out of pocket for the balloon as well as a “smart scale” that connects to an Allurion app, and for coaching by a nutritionist.
While the product would not be covered by health insurance, the cost is considerably less than for gastric-bypass surgery, which is covered by some insurers but not others, Gaur said.
Allurion had previously raised $36 million in venture capital.
Marijn Dekkers, the founder and chairman of Novalis LifeSciences and former chief executive of Bayer and Thermo Fisher Scientific, said Allurion is taking a “cutting-edge approach to one of the world’s largest unmet medical needs.”
A study published last month by the New England Journal of Medicine predicted that by 2030, nearly one in two adults in the United States will be obese. Obesity is defined as a body mass index of 30 or higher.
Jonathan Saltzman can be reached at firstname.lastname@example.org.