Kips Bay Medical Announces FDA Approval for U.S. Expansion of Its eMESH I
Clincal Feasibility Study
MINNEAPOLIS, March 17, 2014 (GLOBE NEWSWIRE) -- 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 an approval for Kips Bay Medical to include more U.S. patients and
U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS^®
In its initial approval, the FDA indicated that it would allow a staged
enrollment within the United States, starting with 15 patients at up to four
sites in the United States. The FDA has now increased the approved number of
U.S. patients from 15 to 27 (15 additional from the 12 enrolled to date) and
increased the allowed number of U.S. sites from four to 10.
In addition, the FDA has also approved a combination of changes in the
application of the eSVS Mesh to the saphenous vein graft and to the surgical
implant technique for the eSVS Mesh treated graft. The changes are intended to
reduce the risk of early graft occlusion, make it easier to implant the eSVS
Mesh and reduce procedural costs.
"We are very pleased with this expanded approval which allows the Cleveland
Clinic, the Lenox Hill Hospital and other interested U.S. sites to become
active and commence enrolling patients in our eMESH I clinical feasibility
trial," commented Manny Villafaña, Founder, Chairman and CEO of Kips Bay. "I
am grateful for the perseverance of our team here at Kips Bay and their
dedication to bringing the eSVS Mesh forward through the U.S. regulatory
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 coronary
artery bypass ("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 CABG surgery. The Company
intends to work with its European and U.S. sites to use its newly approved
implant technique on all patients going forward and further expects to use the
data from this study as the basis for requesting an investigational device
exemption to conduct a larger pivotal trial in the United States.
About the eSVS Mesh
The eSVS Mesh is designed to be fitted like a sleeve on the outside of
saphenous vein grafts 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. To strengthen an SVG,
the eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh
considerable strength, while remaining highly flexible and kink-resistant.
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
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 "believes,"
"continues", "expects," "intends," "should," "will," "may," "could," "hopes,"
"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 expectations regarding enrollments, site activations and other aspects
of its eMESH I clinical feasibility trial; the safety, performance and
benefits of the eSVS Mesh and the anticipated effects of the changes in the
application 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; 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; its ability to obtain coverage and reimbursement from third-party
payors for the eSVS Mesh technology and the extent of such coverage; the
development of its distribution and marketing capabilities; its ability to
attract and retain scientific, regulatory, and sales and marketing support
personnel and its ability to obtain additional financing. 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. Kips Bay
undertakes no obligation to update its forward-looking statements.
CONTACT: Kips Bay Medical, Inc.
Manny Villafana, Chairman and Chief Executive Officer
Scott Kellen, Chief Operating Officer
and Chief Financial Officer, +1-763-235-3540
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