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Gelesis's Plenity Obesity Product Earns De Novo For Wide BMI Range

 
• By Sten Stovall

PureTech's affiliate Gelesis has received US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half.

bmi-calculator
• Source: shutterstock.com

PureTech Health PLC affiliate Gelesis Inc. has won US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, opening up a potentially huge market there for the product.

It is indicated for adults with a body mass index (BMI) of 25-40, the widest BMI range of any FDA-cleared therapy.

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