Obalon Therapeutics, Inc. received approval from the FDA and has begun enrolling its first clinical study in the United States to begin evaluating the safety and efficacy of a fully reversible device for weight loss.
- Clinical trial results reported by Dr. Ariel Ortiz showed 34% excess weight loss in a three-month study in Mexico.
- Dr. Ortiz also announced preliminary results of approximately 45% excess weight loss in a similar European study.
Those are some amazing numbers. I promise I am not thinking about adding this to my gastric bypassed belly, much. I kid.
What is it? Here’s information from the patent application –
An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient’s stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state.
In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity.
After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient’s digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.
Obalon Therapeutics, Inc. announced it closed a $16.5 million Series C private equity financing, began enrolling patients in a U.S. clinical trial, received CE Mark approval and had weight loss data presented at the IFSO European Congress (International Federation for the Surgery of Obesity and Metabolic Disorders).
Obesity is a worldwide epidemic. Although bariatric surgery has demonstrated strong weight loss results, the surgeries are costly, irreversible and used in less than 1% of the eligible population. Physicians, patients and payers all agree there is a compelling need for new products and technologies to address this gap.
Obalon is developing a novel, nonsurgical, fully-reversible device for weight loss. The device consists of a capsule containing a balloon that is swallowed and then remotely inflated. The balloon is intended to occupy space in the stomach to create a feeling of fullness to help people eat less. Additional balloons can be swallowed and inflated during the treatment period as indicated for weight loss. At the end of the treatment period, the balloons are removed.
Your thoughts? Would you try this device had you not had weight loss surgery already?