Weight loss ball company secures $34 million in additional funding

Allurion Technologies has secured an additional $34 million in funding as company-backed startup Natick prepares to seek U.S. 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 which Allurion’s chief executive said was a vote of confidence in his product, a polyurethane balloon that stays in the stomach of a child. a patient for four months.

“This funding allows us to continue to grow at a very rapid rate,” said Chief Executive Officer Dr. Shantanu Gaur, who co-founded Allurion in 2009 with another Harvard Medical School graduate after realizing obesity was the common denominator of many diseases.

Allurion has grown to 100 employees from 60 last year and has invested $1.5 million in a new manufacturing plant in Natick. Its device has already been approved in Europe, the Middle East, Latin America and Asia, and the company has sold 20,000 in 25 countries since 2016.

The product, called 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 visit to the doctor, a patient swallows a large capsule containing a deflated polyurethane balloon attached to a thin catheter. The doctor then fills the balloon with about 2½ cups of water and removes the catheter from the patient’s mouth.

The balloon stays in the stomach for four months, curbing the appetite. Then it collapses and leaves the body the old fashioned way.

In one of the largest gastric balloon datasets ever collected, 1,623 patients at 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 Food and Drug Administration clearance this year based on the results, Gaur said.

If the FDA approves the device, a patient would have to pay around $4,000 out of pocket for the ball as well as a “smart scale” that connects to an Allurion app and for coaching by a nutritionist.

Although the product is not covered by health insurance, the cost is considerably less than 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, founder and chairman of Novalis LifeSciences and former chief executive of Bayer and Thermo Fisher Scientific, said Allurion is taking a “state-of-the-art approach to one of the world’s greatest 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 more.

Jonathan Saltzman can be contacted at jsaltzman@globe.com.