This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

EnteroMedics Weight-Loss Device Is A Pulsing Placebo

ST. PAUL, Minn. (TheStreet) -- The EnteroMedics (ETRM) implantable weight-loss device known as VBLOC is a pulsing placebo.

The company's hopes that VBLOC would be a fat zapper were dashed Thursday night with the release of top-line results from the phase III study known as RECHARGE. Patients implanted with an active VBLOC device lost just 8.5% more "excess weight" than those implanted with a dummy (non-working) device.

The result missed statistical significance by a wide margin, with a p value of 0.70.

EnteroMedics tried to spin the disastrous results from the RECHARGE trial as a near miss and said it would still seek FDA approval for the VBLOC device. [A previous phase III study of VBLOC, known as EMPOWER, also failed.]

Investors weren't fooled, sending EnteroMedics shares down 53% to $1.35 in Thursday's after-hours trading session.

VBLOC is a surgically implanted device that uses electrical pulses to block the primary nerve regulating digestion. Unlike pacemakers, patients power the EnteroMedics' VBLOC device on and off with a control belt worn around the waist. When VBLOC is on, patients are supposed to feel less hungry, eat less and lose weight.

Except patients didn't lose weight. Obese patients implanted with a fully operational VBLOC device achieved a 24.4% average "EWL" compared to 15.9% for patients implanted with a sham device.

"EWL" stands for excess weight loss and is calculated as a percentage equal to total weight loss in the trial (the numerator) divided by the difference in baseline weight and "ideal weight" using a BMI of 25 (the denominator.)

In order for the study to be successful, VBLOC was required to hit a 10% statistical superiority margin over the sham device. From a non-statistical perspective, that meant the VBLOC EWL needed to be approximately 20% higher than the EWL of the sham device. Clearly, the 8.5% numerical difference came nowhere close to a 20%.

VBLOC also missed another efficacy measure of weight loss that served as the study's co-primary endpoint.

EnteroMedics didn't provide any details on the mean weight loss or body mass index of the patients enrolled in the study, making it impossible to calculate the actual weight loss by VBLOC patients.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,079.57 -42.44 -0.25%
S&P 500 1,996.74 -3.38 -0.17%
NASDAQ 4,557.6950 -11.9260 -0.26%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs