Currently, I am the Chief Medical Officer and Executive VP of Gelesis - a highly innovative life sciences company that has pioneered a platform technology of super absorbent hydrogels to address some of the most important population health problems in the developed world - including obesity and prediabetes/diabetes. These super-absorbent hydrogels mimic the action of vegetables and fruits in the body by absorbing many times their size in water. When taken orally in capsules, tiny gel particles hydrate to 100x their original size in the stomach and create a sense of natural fullness and satiety. Made from naturally-derived food products (e.g., cellulose and citric acid) these hydrogels have demonstrated effectiveness and remarkable safety in the treatment of overweight and obesity. Gelesis recently launched a FDA cleared product for overweight and obesity called Plenity based on this novel technology.
You do not have to have success on both endpoints for the FDA to approve a device. Other drugs, in addition to devices, have been approved on the basis of success of one endpoint.15 August 2021