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

Article preview from Start-Up - September, 2012

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

Article preview from Start-Up - September, 2012

Start-ups with an array of compelling devices aim 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?

 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 only do bariatric start-ups face the standard hurdles of securing financing and gaining physician acceptance, but the US Food and Drug Administration (FDA) is being very cautious when it comes to approving obesity devices. This May, an FDA advisory panel determined that high-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, and it established a framework to assess risk based on rates of expected and unexpected events. This ongoing ambiguity surrounding FDA study design for the newer-generation obesity devices is stalling growth in the overall bariatrics device market, says Bill Plovanic, managing director of equity research, medical devices, at Canaccord Genuity.

Continued...

To read this article in its entirety, purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Start-Up.

About Start-Up

No publication reviews leading edge companies and technology better than Start-Up. Each issue of Start-Up profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.

Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512