MINNEAPOLIS, Oct. 14, 2014 (GLOBE NEWSWIRE) -- Kips Bay Medical, Inc. (OTCQB: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, or CABG, surgery, today provides an update on its clinical progress and business operations.
Enrollment Begins in the Czech Republic
On September 30, 2014, the first implant of an eSVS Mesh in the Czech Republic was performed at the Hospital Na Homolce in Prague. Two additional hospitals in Prague, University Hospital Kralovske Vinohrady and Vseobecna Fakultni Hospital, have also enrolled patients. These implants were performed as part of Kips Bay's eMESH I clinical feasibility trial currently being conducted for the U.S. Food and Drug Administration (FDA).
Feasibility Study Update
As previously announced, the Company received an updated CE Mark approval on August 20, 2014 for its new surgical implant technique for its eSVS Mesh. This updated approval was required for the Company's European study sites to continue enrolling patients in the Company's eMESH I clinical feasibility trial.
With the conclusion of the traditional summer break in Europe, the Company has been able to complete training of all existing European clinical study sites on the new surgical implant technique. The completion of this training and the activation of the three new study sites in the Czech Republic have increased the recent pace of enrollment in Europe. Since September 5, 2014, an additional 8 patients have been enrolled, bringing total patient enrollments in the Company's eMESH I clinical feasibility trial to 65. The Company believes approximately 36 additional patients, treated with the new surgical implant technique, will be needed to complete enrollment for this trial.
Kips Bay currently has six study sites in the United States, which include the Mayo Clinic, the Cleveland Clinic, Emory University, the Lenox Hill Hospital, the Texas Heart Institute and the Northeast Georgia Medical Center, that are recruiting patients for the trial. One additional site is expected to be recruiting within the next 60 days. Enrollments at the U.S. sites continue to be slow, which the Company believes may be due, in part, to the challenge of finding patients that match the enrollment criteria. To assist the study sites and further increase the pace of enrollments, the Company has focused the efforts of its two sales directors on supporting the clinical study sites in both the United States and Europe. In addition to focusing sales personnel on the support of the feasibility trial, the Company has scrutinized its expenses to curtail spending that does not support the completion of the feasibility trial or obtaining the five-year follow-up information.
Five-Year eSVS Mesh Performance Information
The Company is in the process of obtaining follow-up angiograms from certain patients that participated in its original international human clinical trial, the "CE Mark" trial, whose eSVS Mesh treated saphenous vein grafts were open, or patent, at the conclusion of the trial. Enrollments in this original trial occurred between August 2008 and July 2009. Follow-up angiograms from these patients will provide an opportunity to evaluate the performance of the eSVS Mesh treated grafts five to six years after bypass surgery. The Company hopes that these follow-up angiograms will provide a meaningful indication of the potential long-term performance of the eSVS Mesh.
In order to accomplish this follow-up study, the Company, working with the investigators/surgeons at the original hospitals, is required to obtain approval from the ethics committee of each hospital in order to approach the patients and request their participation in this follow-up study. Two of the original hospitals have received this approval and are actively contacting their original study patients. To date, the Company has received follow-up angiograms from three patients and is currently having these angiograms evaluated by an independent laboratory. The Company expects three of the seven original study sites to participate in this follow-up study and hopes to receive 10 to 15 follow-up angiograms by the end of this year.
Transition to OTCQB Marketplace
On September 12, 2014, trading of the Company's common stock moved to the OTCQB Marketplace. The Company's shares trade under the symbol "KIPS" on the computerized OTCQB system.
Operated by the OTC Markets Group Inc., the OTCQB is a market tier available to OTC traded companies that are registered and reporting with the Securities and Exchange Commission and meet certain initial and ongoing bid price requirements. Investors are able to view Level II Real Time stock quotes for Kips Bay at www.otcmarkets.com.
About the eSVS Mesh
The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts, or SVGs, to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, the Company hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. The eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh considerable strength, while remaining highly flexible and kink-resistant. Kips Bay is currently conducting a feasibility trial for the FDA, the objective of which is to demonstrate the initial safety and performance of the eSVS Mesh. If the trial is successful, Kips Bay expects to use the data from this study as the basis for the filing of a request for an investigational device exemption, or IDE, to perform a larger pivotal study which is required to demonstrate clinical effectiveness and support a request for approval to sell the eSVS Mesh in the United States. Additional information about the eSVS Mesh and the Company's feasibility trial are available at the Company's website at www.KipsBayMedical.com and in the Company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.
About Kips Bay Medical
Kips Bay Medical, Inc. is a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, the eSVS Mesh, for use in coronary artery bypass grafting surgery. Kips Bay originally acquired the eSVS Mesh technology from Medtronic, Inc. in 2007. Additional information about Kips Bay is available at the Company's website at www.KipsBayMedical.com.
Forward-Looking Statements Safe Harbor
Statements contained in this release that relate to future events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations of future events and often can be identified by words such as "continues," "expects," "hopes," "intends," "should," "will," "may," "believes," "could," "anticipates," "objective," "future," other words of similar meaning or the use of future dates. Examples of forward-looking statements in this release include Kips Bay's plans and expectations regarding enrollments, site activations and other aspects of its eMESH I clinical feasibility trial; Kips Bay's expectations regarding the follow-up study; and Kips Bay's expectations regarding the safety, performance and benefits of the eSVS Mesh. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Kips Bay's actual results to be materially different than those expressed in or implied by Kips Bay's forward-looking statements. For Kips Bay, such uncertainties and risks include, among others, the status of the eMESH I clinical feasibility trial, including enrollment, completion and the results; the status and results of Kips Bay's follow-up study; Kips Bay's future operating results and financial performance; market size and market acceptance of the eSVS Mesh technology; the ability of Kips Bay and its distributors to commercialize and sell the eSVS Mesh in Europe; and Kips Bay's need for and ability to obtain additional financing to continue its feasibility trial. More detailed information on these and other factors that could affect Kips Bay's actual results are described in Kips Bay's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Kips Bay undertakes no obligation to update its forward-looking statements.
Kips Bay Medical, Inc.
Manny Villafaña, Chairman and Chief Executive Officer, +1-763-235-3540
Scott Kellen, Chief Operating Officer and Chief Financial Officer, +1-763-235-3540
Source:Kips Bay Medical