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
TheStreet Open House

Biotech Stock Mailbag: Mela Sciences

BOSTON ( TheStreet) -- Housekeeping item: The next Biotech Stock Live Chat is scheduled for Thursday, Sept. 15 at 12 p.m. ET. Please join me and bring all your biotech stock investing questions.

Mela Sciences (MELA) received a CE Mark, or regulatory clearance, to sell its MelaFind skin cancer-detection device in Europe this week.

Via Twitter, @VexTrades says, "Greetings from vacation in Lake George, NY. Great news for $MELA, and the bashers are still out in full force, headed by @adamfeuerstein"

@TimMcFadden2 asks, "Come on Adam, MELA is blowing up today. Still sticking to your guns on its demise?"

Bob S. emails, "How much sales will a CE mark for MELA garner?"

Let's clear up the confusion this CE Mark announcement caused:

A CE Mark is not the European regulatory equivalent of an FDA medical device approval. The lead sentence from a Reuters story Wednesday on medical device regulation in Europe sums it up best:

"Pacemakers and electric toasters have little in common, yet in Europe the same regulatory framework covers both and a growing number of doctors think the system is no longer up to the job."

Mela was able to garner a CE Mark for MelaFind because the only regulatory hurdle is basic patient safety. Clinical trials that determine patient benefit or efficacy of a medical device are generally not required in Europe for a CE Mark. The standards for most (not all) medical device approvals are higher in the U.S., which is why you see so many medical device companies seeking approvals or clearances in Europe first.

Mela, of course, knows all too well how tough the FDA can be. The agency has refused to approve MelaFind, with FDA reviewers sharply criticizing the accuracy of MelaFind's skin-cancer detection results. FDA reviewers have also raised concerns about the potential for misdiagnosis of skin cancer that could result if MelaFind were used incorrectly.

"FDA's Mission is to Protect and Promote the Public Health and the FDA review team has significant concerns this device has not been studied adequately for its current indications for use and therefore puts the health of the public at risk," FDA reviewers warned in their MelaFind review released last year.

Barring a miracle or major (and scandalous) political intervention, MelaFind is not going to receive U.S. approval any time soon. Mela's CE Mark in Europe is the consolation prize, which does allow the company to sell the device to European dermatologists. Convincing European doctors to buy and use MelaFind is a much more challenging task given the dark cloud hanging over the device due to the FDA's concerns.

1 of 3

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 17,279.74 +13.75 0.08%
S&P 500 2,010.40 -0.96 -0.05%
NASDAQ 4,579.7870 -13.6380 -0.30%

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