PlenSat’s technology involves the production of ingestible ‘pills’ that are self-inflating in the acidic environment within the stomach. The expanded capsule, a “Digestible Balloon”, is sized such that once inflated it will not pass beyond the stomach until time and abrasive wear breaks it down. It is anticipated, based upon our pre-clinical investigations, that the Digestible Balloon will have a lifetime of between 14 and 30 days within the stomach. A recent preclinical pilot study in a dog with a single capsule proved that the capsules do inflate to the appropriate size to remain in the stomach for an extended time. The Digestible Balloon is ultimately be digested in the intestine and passed after mechanical breakdown in the stomach.
The Company believes that the Digestible Balloon can achieve the level of fullness obtained with Bariatric Balloons or the LapBand™. This technology will allow patients to gain this therapeutic benefit with minimum or no physician intervention. The size of the Digestible Balloon is such that between 5 and 10 will be resident in the stomach to achieve the desired effect. The capsules can be ingested over several days and this slow introduction of the change in stomach volume will eliminate one of the major drawbacks to current Bariatric therapies. Current techniques, including surgical modifications, the Lapband and the endoscopically placed balloons, all have the potential side effect of severe gastrointestinal disruption leading to dehydration and hospitalization due to the immediate change in stomach volume.
PlenSat has developed a novel approach to achieving a sense of fullness, without the use of drugs; with a patented device constructed of safe materials currently being utilized in common foods. The PlenSat digestible balloon system is a medical device that is designed to stay resident in the stomach for extended periods of time.