UPDATED: IntraPace preps anti-obesity device for U.S. regulatory path

After gaining European regulatory approval last year, IntraPace is now preparing its Abiliti anti-obesity medical device for the demanding U.S. regulatory pathway. The California company's technology could upend the market--as it stands so far--once it achieves FDA approval, a Bloomberg story concludes.

Why would that be? Dieting and exercise doesn't always work for some patients, and surgical options, such as the gastric bypass procedure, carry plenty of health risks, according to the article. That means a successful anti-obesity medical device with minimal side effects stands to generate plenty of cash in the U.S., where obesity costs the U.S. plenty in medical expenses and lost productivity, about $147 billion annually, as Bloomberg notes. And 1 in 3 adults here are obese, which creates an enormous market with an arguably profound need for viable, lasting treatments.

In its favor, IntraPace comes in with a pretty substantial pedigree. The company's core technology is based on defibrillator and cardiac pacemaker tech developed by device giant Medtronic ($MDT). (CEO Chuck Brynelsen is himself a veteran Medtronic cardiac exec.) Device titans Boston Scientific ($BSX) and Johnson & Johnson ($JNJ) are among investors that helped fuel Abiliti's development, according the article. The compact implant is about as big as a half-inch stack of business cards, according to the article. It makes patients feel full and eat less, thanks to low electrical pulses sent to the stomach that can be programmed to outline a defined mealtime window. IntraPace has also drawn more than $65 million in venture investment.

Also a plus: Surgeons implant the device using minimally invasive laparoscopic surgery. And patients can either have the device batteries replaced every 5 years or have it removed whenever they choose. What's more, Abiliti patients thus far also haven't been left with health problems that patients experience after gastric bypass surgery, which can lead to problems absorbing nutrients, among many other health complications. Allergan's ($AGN) Lap-Band, which tightens around the stomach to help patients eat less, has also become a point of controversy. A recent study found that almost half of all patients who received the enormously popular device either experienced no weight loss at all or had to have it removed, many after enduring long-term complications.

As well, a one-year study of 25 Abiliti patients completed in March showed patients experienced an average 30% drop in excess weight, which is a similar result to gastric banding surgery. Results from a new, randomized trial will be released by next June, Brynelsen told Bloomberg, comparing 150 Abiliti patients who used the device for 12 months to patients who chose gastric banding surgery. While the company did not disclose to Bloomberg when it would submit Abiliti to the FDA, IntraPace said the randomized trial will help support the submission. One observer told Bloomberg that an FDA application could come three to 5 years after IntraPace's CE mark in the EU, due to the FDA's added requirements for safety and efficacy.

Certainly, market supremacy isn't guaranteed. A number of companies are developing anti-obesity medical devices with various approaches. And as Bloomberg notes, IntraPace faces at least one major rival using a similar approach: EnteroMedics in Minnesota. EnteroMedics generated promising results, announced in April, from a trial involving 19 patients over 30 months. A 233-patient trial is now under way (compared with placebo), with results expected early next year, a crucial step before seeking FDA clearance or approval. 

- read the Bloomberg story

Special Reports: Intrapace - Top 10 medical device VC deals, H1 2011 | Intrapace - Top 10 Medical Device VC Deals of 2010

Editor's note: This story has been revised in the fourth paragraph to more accurately reflect IntraPace's venture funding to date.

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