Kips Bay Medical Announces Receipt of FDA Approval to Begin Clinical Study of the eSVS® Mesh in the United States

  Kips Bay Medical Announces Receipt of FDA Approval to Begin Clinical Study
  of the eSVS® Mesh in the United States

Business Wire

MINNEAPOLIS -- November 08, 2012

Kips Bay Medical, Inc. (NASDAQ:KIPS) along with Manny Villafaña, its Founder,
Chairman and CEO, announced today that the United States Food & Drug
Administration (“FDA”) has granted approval with conditions of Kips Bay
Medical’s Investigational Device Exemption (“IDE”) to include four U.S. study
sites in the “eMESH I” clinical feasibility trial of its eSVS Mesh. As
previously announced, this study commenced in Bern, Switzerland on August 31,
2012.

The eMESH I clinical feasibility trial is a multi-center, randomized study of
external saphenous vein support using Kips Bay Medical’s eSVS Mesh in CABG
Surgery. The objective of this study is to demonstrate the initial safety and
performance of the eSVS Mesh for use as an external saphenous vein graft
(“SVG”) support device during coronary artery bypass (“CABG”) procedures
sufficient to allow the FDA to approve an IDE for a pivotal study in the U.S.
The Company expects to enroll up to 120 patients at eight European and four
U.S. sites.

In its approval, the FDA indicated that it will allow a staged enrollment
within the United States starting with five patients. Kips Bay Medical will
provide the six-month follow-up angiogram data of five U.S. patients or 10
outside the United States and U.S. patients combined, as well as additional
data the FDA requested, for the FDA to review prior to approving the remaining
35 U.S. patients initially requested by the Company. There is, however, no
assurance that the FDA will provide such approval.

About Kips Bay Medical

Kips Bay Medical, Inc., founded in 2007 and headquartered in Minneapolis,
Minnesota, is a medical device company focused on manufacturing and
commercializing its external saphenous vein support technology, or eSVS Mesh,
for use in coronary artery bypass grafting surgery. The eSVS Mesh is a nitinol
mesh sleeve that, when placed over a saphenous vein graft during CABG surgery,
is designed to improve the structural characteristics and long-term
performance of the saphenous vein graft. Additional information about Kips Bay
Medical, Inc. can be found at www.KipsBayMedical.com.

Safe Harbor

Certain statements in this news release are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 and are
provided under the protection of the safe harbor for forward-looking
statements provided by that Act. For example, statements in this press release
regarding Kips Bay Medical intent to file an amended IDE application and
anticipation of patient enrollments are forward-looking statements. These
statements involve risks and uncertainties which could cause results to differ
materially from those projected, including but not limited to the risks
detailed from time to time in Kips Bay Medical’s SEC reports, including its
most recent annual report on Form 10-K and subsequent quarterly reports on
Form 10-Q. Kips Bay Medical encourages you to consider all of these risks,
uncertainties and other factors carefully in evaluating the forward-looking
statements contained in this release.

Contact:

Kips Bay Medical, Inc.
Manny Villafaña, +1-763-235-3540
Chairman and Chief Executive Officer
Manny.Villafana@KipsBayMedical.com
or
Scott Kellen, +1-763-235-3540
Chief Operating Officer and Chief Financial Officer
Scott.Kellen@KipsBayMedical.com