Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for obesity, setting it up to rival Novo Nordisk in this lucrative market.
Plenity, developed by PureTech’s affiliate Gelesis and previously known as Gelesis100, is a capsule containing a super-absorbent hydrogel that absorbs water and increases the volume and elasticity of the stomach and small intestine contents to help people feel full. The capsules are taken before lunch and dinner and are designed to prevent calorie intake to aid weight loss.
The approval allows the device to be used in adults with a Body Mass Index (BMI) of 25-40 kg/m2. Nearly 150 million adults in the United States fall into this category, and PureTech noted that Plenity is the only prescription weight management product to be cleared for use in adults with BMI as low as 25 kg/m2.
