Update: This story has been edited to include Obalon's premarket approval and more information about other FDA-approved obesity balloons.
Obesity balloon maker Obalon filed to raise up to $75 million in an IPO to launch its gastric balloon that has been approved recently by the FDA.
The Obalon balloon is the third obesity balloon to be approved by the FDA. It joins ReShape Medical's dual balloon system and Apollo Endosurgery's Orbera balloon. Unlike the two previously approved balloons, the Obalon is swallowed and then inflated with gas, whereas Orbera and ReShape's Dual Balloon are placed via endoscopy and inflated with saline. Orbera and the Dual Balloon both received the FDA nod in 2015, while Obalon hopes to launch its balloon system in early 2017. Apollo also markets the Lap-Band, an adjustable gastric banding system.
The device received FDA premarket approval for temporary use in patients with a BMI of 30 to 40 who have failed to lose weight through diet and exercise, the company said in an S-1 filing. After the placement of the first balloon, More Obalon balloons may be placed during the 6-month treatment period, and they are removed at the end of treatment in an endoscopic procedure. The device is intended to be used alongside a “moderate intensity diet and behavior modification program.”
The PMA nod is based on a U.S. pivotal trial involving 387 patients. The patients treated with Obalon lost an average of twice as much body weight as patients who received a sham treatment, Obalon said in the filing. Obalon patients maintained most of their weight loss 6 months after removal of the balloons. The FDA approved labeling includes a requirement that physicians complete a training program before they can place the device.
Unlike the Lap-Band, intragastric balloons like Obalon are not reimbursed by Medicare, Medicaid or third-party payers. As the company does not expect third-party insurers to reimburse for Obalon treatment, it is hoping physicians will adopt a self-pay model and patients to pay out of pocket, according to the filing.