PlenSat is a pre-clinical stage medical device company developing a new approach to obesity control. The Company has conceived of a new device, The Digestible Balloon, which the Company believes will provide the benefits of bariatric surgery (stomach stapling, stomach banding, gastric bypass, and gastric balloon insertion) without medical intervention. This new device will potentially provide ease of use and reversibility to the increasingly popular invasive approaches, including endoscopic procedures. These invasive procedures have demonstrated the ability to control excessive food consumption leading to life style changes and sustainable weight reduction in numerous.
The use of the Digestible Balloon will allow a pharmaceutical ‘pill’ approach to delivery of a stomach space filling device for hunger control. There are literally 10’s of millions of overweight and obese individuals that can be classified as pre-diabetic or otherwise suffering from their condition with physical issues. The numbers of individuals overwhelms the ability of the healthcare community to provide bariatric therapy, in the form of bypass surgery, laparoscopic banding or endoscopic intragastric balloon insertion and removal. A self inflating device that is eliminated over time by natural digestive action is a simple approach to this problem for many individuals.
Obesity is caused by a combination of genetics, environmental issues, and behavioral factors.1,2,3 Consumption of high-calorie foods, consumption of too much food, and a sedentary lifestyle all work together to create this condition. Obesity is associated with the development of diabetes mellitus, hypertension, dyslipidemia, arthritis, sleep apnea, cholelithiasis, cardiovascular disease, and cancer. More than 100 million Americans (65% of the adult population) are overweight. Obesity is the second-leading cause of preventable death in the United States after smoking. Obesity-related diseases account for 400,000 premature deaths each year. Obesity can be treated medically and surgically. Medical treatment for obesity is difficult, because the amount of weight lost is small and patients tend to regain most of the weight.1 A 2010 prospective, randomized controlled trial in 50 adolescents demonstrated that a greater percentage of patients achieved a loss of 50% of excess weight with laparoscopic gastric banding than with lifestyle intervention.4 Operations that are designed to cause significant and long-lasting weight loss in patients who are severely obese are termed bariatric surgery. The term bariatric surgery is derived from the Greek words baros (weight) and iatreia (medical treatment). Laparoscopic lap band placement, described here, is one such surgery. For information on gastric bypass (another form of bariatric surgery), see eMedicine article Laparoscopic Gastric Bypass. Body mass index (BMI) describes relative weight for height and correlates significantly with an individual’s total body fat.3 BMI is based on height and weight and applies to adults of both sexes. BMI is calculated as follows: BMI equals weight in kg/height in m2 or weight in lb/height in square inches.5,2
2. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Morbid-Obesity.Info. SAGES Web site. Available at http://www.morbid-obesity.info/. Accessed November 10, 2008.
3. National Institutes of Health. U.S. Department of Health and Human Services. Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. Obesity Education Initiative
4. [Best Evidence] O’Brien PE, Sawyer SM, Laurie C, Brown WA, Skinner S, Veit F, et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA. Feb 10 2010;303(6):519-26