The Fight Against Fat: Start-Ups Look To Serve A Vast Market With Minimally Invasive Bariatric Devices

With one in three adult Americans struggling with obesity and demand increasing for less invasive or incisionless alternatives to gastric bypass surgery and laparoscopic adjustable gastric banding to treat morbid obesity, it is an exciting and yet a challenging time to be a bariatric device start-up. The morbidly obese – those who are 100 pounds or more overweight – now represent about 5.5% of the US population. This percentage is forecast to double by 2030, according to the Centers for Disease Control & Prevention (CDC) of the US Department of Health and Human Services, placing a colossal burden on the health care system. In addition, there is a huge and growing pool of relatively less obese patients with body mass indices (BMIs) in the 30+ range who are not (yet) eligible for bariatric surgery. Thus, there is a dire and growing need to address these populations with less invasive, less expensive, and less risky bariatric devices that can fill the product void between invasive surgery and diet and exercise regimens, as well as drug therapy, the latter of which is generally not effective or tolerable in the long term. An array of compelling minimally invasive and endoluminal technologies is attempting to mimic the effects of gold standard gastric bypass surgery.

However, just as the stomach is an inhospitable environment for medical devices, so is the clinical and regulatory one. Not...