Start-ups with an array of compelling devices are seeking to provide alternatives to invasive gastric bypass surgery and laparoscopic gastric banding for the millions of morbidly and moderately obese patients – but which ones will make it through the evolving FDA clinical process? In this issue we profile three young companies that hope to succeed: Aspire Bariatrics, EndoSphere, and Vibrynt.

The market for obesity products has blockbuster potential, but it’s proven an elusive target for the medical device industry. The challenging regulatory environment, weak economy, and skittish investors have slowed the number of product launches in recent years, and there have been some high-profile setbacks for several potential weight loss therapies. But now, a "back to basics" movement, focused on understanding the physiological triggers behind obesity rather than simply restricting food intake, hopes to spur development of more effective minimally invasive weight loss solutions.

Numerous physiologic pathways lead to obesity; those related to hunger, satiety, the breakdown and absorption of nutrients, and the regulation of energy. Given the complexity of obesity, it's not surprising that diet and exercise aren't currently effective and that drugs have had only modest success. Bariatric surgery, on the other hand, which reduces the size of the stomach (and, in some versions, also reroutes part of the small intestine so that food bypasses it) is extremely successful. Many patients that have undergone the Roux-en-Y gastric bypass procedure have sustained losses of 50% of their excess weight out to ten years and beyond. Now companies with minimally invasive devices for the treatment of obesity hope to fill the therapy gap between dieting and invasive surgery. It's too early to claim victory, but start-ups and scientists are benefiting from a better understanding of why gastric bypass surgery works.

With soaring medical costs weighing heavily on the US economy, it's not surprising that obesity has become a target in the health care reform debate. Obesity is costly because it significantly increases the risk of many chronic diseases. Exercise, dieting and prescription drugs have had a limited effect in stemming the tide of obesity, leaving bariatric surgery and other interventional techniques as the primary treatment options for this potentially multi-billion dollar market. But device manufacturers have a challenge ahead of them--to develop more effective, safer, and less invasive obesity therapies that will not only result in long-term weight loss, but will also cut treatment costs and better manage comorbidities.