“We will always be grateful to Mike Winegar for his tremendous contribution over the past four years and deeply saddened by his decision to retire” said Mr. Villafaña. “But we are also very fortunate to be able to welcome two very experienced and successful leaders to our team who will help us build on the accomplishments of Kips Bay.”The Company received its European CE mark for its eSVS MESH in May 2010, which was the result of successfully completing a 90 patient study in seven countries. The first patient from the Company’s international study has now had an eSVS MESH implant for over 2½ years. The Company has begun commercialization of the eSVS Mesh outside of the U.S. with approximately 14 centers presently implanting the eSVS Mesh, including six centers in Switzerland, six centers in Italy and one center each in the United Arab Emirates and Ireland. As of today the Company estimates over 200 implants have been completed. The Company continues to work with the United States Food & Drug Administration (“FDA”) to obtain an Investigational Device Exemption (“IDE”) to commence a clinical trial in the U.S. Twelve (12) highly regarded clinical trial sites have indicated their interest in participating in our IDE trial. Additionally, the Company is in discussions with a number of key institutions in Europe to begin a post market study which the Company believes will develop long-term data demonstrating the effectiveness of the eSVS MESH. The Company expects the results of this study will facilitate our efforts to secure additional regulatory and reimbursement approvals for our eSVS MESH. Patent Update The Company also announced that it has received its first issued eSVS MESH patent, which was received from Japan. As previously communicated, the Company has recently received notices of allowance on one Canadian application and one European application. Therefore the Company now has six patent applications pending in the United States and one issued and ten patent applications in countries outside the United States. The Company also has one pending international patent application which will be filed in Europe and Japan by May 2011.
About Kips Bay MedicalKips Bay Medical, Inc., founded in 2007 and headquartered in Minneapolis, Minnesota, is a development stage medical device company focused on developing, manufacturing and commercializing its eSVS MESH for use in coronary artery bypass grafting surgery. 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 (i) obtaining an Investigational Device Exemption (“IDE”) to commence a clinical trial in the U.S.; and (ii) beginning a post market study to develop long-term data demonstrating the effectiveness of the eSVS MESH 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 potential for the FDA’s refusal to grant, or delays in granting, IDE approval and unanticipated delays in enrolling medical centers and patients for clinical trials and other factors detailed from time to time in our SEC filings, including our prospectus filed on February 11, 2011. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.