PureTech firm Gelesis gets Europe approval for 'Plenity'

The FTSE 250 company said Gelesis received a CE-mark for Plenity as a class 3 medical device, indicated for weight loss in overweight and obese adults with a body mass index of between 25 and 40, when used in conjunction with diet and exercise.

It said Gelesis would now be able to market Plenity throughout the European Economic Area and in other countries that recognise the CE mark.

Gelesis previously received clearance for Plenity from the US Food and Drug Administration (FDA), and planned to bring Plenity to the United States first, where it is now available to a limited extent while it ramps up its commercial operations and inventory for a broad launch in 2021.

“This is an important milestone for Gelesis and for the millions of adults across Europe who are seeking to manage their weight,” said PureTech’s chief innovation officer Eric Elenko.

“We look forward to continued progress from Gelesis' novel hydrogel platform and to the broad launch of Plenity across of the world.”

At 0950 BST, shares in PureTech Health were up 2.2% at 255.5p.