This Day On The Street
Continue to site
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

Kips Bay Medical Provides Business Update And Reports Second Quarter 2013 Results

Kips Bay Medical, Inc. (NASDAQ: KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS ® Mesh, for use in coronary artery bypass grafting surgery, today provided a business update and announced financial results for its second quarter ended June 29, 2013.

FDA Update

Enrollments and site activations are continuing in the Kips Bay eMESH I clinical feasibility trial. This includes the activation of two additional U.S. sites, the Texas Heart Institute in Houston, Texas and the Emory University Hospital Heart and Vascular Center in Atlanta, Georgia. Both sites have completed their internal review and approval processes, have received study approval from the Center for Medicare and Medicaid Services and have begun to actively recruit patients. This brings the number of actively recruiting sites to nine as of August 1, 2013, with five in Europe and four in the United States. Kips Bay also plans to add some additional international sites going forward. As of August 8, 2013, 29 patients have been enrolled in the eMESH I clinical feasibility trial, up from 16 patients at the end of the first quarter of this year.

The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using the Company‚Äôs eSVS Mesh in coronary artery bypass grafting (CABG) surgery for the U.S. Food and Drug Administration (FDA). Currently, to be eligible to participate in the eMESH I study, the patient must meet a number of specific criteria as identified in the study protocol, including having two vein graft segments which qualify for use of the eSVS ® Mesh - one vein graft that receives the eSVS Mesh and one vein graft that serves as a control.

After discussions with several cardiac surgeons participating in the trial, the Company has requested a modification to the study protocol allowing the enrollment of patients with only one qualifying graft. Based upon initial discussions with the FDA, the Company is currently implementing this modification with its European study sites and expects to modify the US protocol upon the receipt of approval from the FDA. The first European sites are expected to be in a position to begin enrolling patients with one qualifying graft in early September. The Company hopes to obtain FDA approval of this modification for the U.S. sites shortly thereafter.

1 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.24 0.00%
FB $117.81 0.00%
GOOG $701.43 0.00%
TSLA $211.53 0.00%
YHOO $36.94 0.00%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs