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!

Kips Bay Medical Provides FDA Update & Reports Fourth Quarter And Full Year 2012 Results

Kips Bay Medical, Inc. (NASDAQ: KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, today provided an update on its progress with the U.S. FDA and announced financial results for fourth quarter and year ended December 31, 2012.

FDA Update

Recent highlights:

  • Receipt of IDE approval with conditions from the U.S. FDA.
  • U.S. FDA approves enrollment expansion to 15 patients in the U.S.
  • First eSVS Mesh Implants in the U.S.
  • U.S. FDA removes conditions from IDE approval.

Kips Bay is currently conducting a feasibility trial in the United States and Europe. This trial is a multi-center, randomized study of external saphenous vein graft (“SVG”) support using the Company’s eSVS ® Mesh in CABG Surgery and is titled the eMESH I clinical feasibility trial. The objective of this trial is to demonstrate the initial safety and performance of the Company’s eSVS Mesh for use as an external SVG support device during coronary artery bypass procedures. Kips Bay Medical expects to enroll up to 120 patients at eight European and four U.S. sites. Enrollments in the eMESH I trial commenced in late August 2012 at the Bern University Hospital, Bern, Switzerland. The primary safety endpoint is the rate of major adverse cardiac events (“MACE”) within 30 days of the procedure. The eSVS Mesh performance will be evaluated based upon the angiographic patency rate of the enrolled grafts, where patency is defined as less than 50% stenosis, or blockage, of the SVG at six months after surgery. As of March 1, 2013, six sites in Europe and the United States have received ethics committee approval and are actively recruiting patients. The Company expects to use the data from this study as the basis for the filing of a request for an Investigational Device Exemption (“IDE”) to perform a pivotal trial in the United States and Europe.

On November 8, 2012, Kips Bay announced that the U.S. Food and Drug Administration (“FDA”) had approved with conditions our application for an IDE to include four U.S. study sites in the eMESH I clinical feasibility trial of the Company’s eSVS Mesh. In its approval, the FDA indicated that it was allowing a staged enrollment within the United States starting with five patients. In January 2013, the FDA expanded their approval to allow for 15 patients. The Company will provide six-month follow-up angiogram data for five U.S. patients or, alternatively, a combination of 10 patients from inside and outside the United States, for the FDA to review. If the FDA determines that these angiograms are acceptable, the Company expects to receive the approval from the FDA to enroll the remaining 35 U.S. patients initially requested by the Company.

In February-March 2013, the first three U.S. patients were implanted with the eSVS Mesh at the Northeast Georgia Medical Center in Gainesville, Georgia. These implants were performed as part of the Kips Bay Medical eMESH I clinical feasibility trial.

On March 7, 2013, in response to additional information the Company provided to the FDA, the FDA notified the Company that it had satisfactorily addressed the conditions indicated by the FDA in the Agency’s November 8, 2012 approval noted above.

1 of 5

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 16,915.07 -70.54 -0.42%
S&P 500 1,964.68 -8.15 -0.41%
NASDAQ 4,396.2040 -22.83 -0.52%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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