Cardica Submits MicroCutter XCHANGE™ 30 510(k) Application For Marketing Clearance

   Cardica Submits MicroCutter XCHANGE™ 30 510(k) Application For Marketing
                                  Clearance

PR Newswire

REDWOOD CITY, Calif., Aug. 16, 2013

REDWOOD CITY, Calif., Aug. 16, 2013 /PRNewswire/ --Cardica, Inc. (Nasdaq:
CRDC) today announced that it filed regulatory documents with the U.S. Food
and Drug Administration (FDA) for marketing clearance of the MicroCutter
XCHANGE™ 30, a cutting and stapling device designed to be used in multiple
open and minimally invasive surgical procedures. The XCHANGE 30 has a
cross-sectional area six times smaller than conventional surgical staplers and
articulates up to 80 degrees in each direction. The lower profile provides
greater access through a 5 mm trocar.

The submission to the FDA includes the results of Cardica's recently completed
MicroCutter European Trial (MET1). In the MET1 study, the MicroCutter XCHANGE
30 met the primary endpoint, freedom of MicroCutter-related severe adverse
events when compared to historical controls from the medical literature, with
only one event in 160 patients enrolled and 423 deployments.

"The filing of our 510(k) application represents the culmination of effort
from many key contributors including the employees who worked tirelessly to
deliver an innovative device that addresses a surgical need, the leading
physicians who tested the XCHANGE 30 and provided invaluable feedback and the
patients that underwent surgical procedures facilitated by the device,"
commented Bernard A. Hausen, M.D., Ph.D., President and Chief Executive
Officer of Cardica. "Pending market clearance by the FDA, we look forward to
introducing the MicroCutter XCHANGE 30 in the United States, the world's
largest surgical stapling market."

About the MicroCutter XCHANGE 30

Cardica's MicroCutter XCHANGE 30 is available in select centers in Europe
today. The device has a cross-sectional area six times smaller than
conventional staplers, and articulates up to 80 degrees. The device uses
reloadable cartridges with a 30-millimeter staple line length. Laparoscopic
procedures today are primarily performed through 5- to 10-mm trocars ports. To
accommodate conventional stapling technology, however, surgeons are forced to
use 12- or 15-mm trocars, which can result in high post-operative pain, port
site infection or ventral hernias. These complications can prolong surgical
time, delay discharge, and result in unnecessary hospital readmissions. The
smaller cross-sectional area, diameter and much higher articulation of the
XCHANGE 30 platform are designed to allow easier access through smaller,
less-invasive ports, and to enable faster and easier access to vital organs
and tissue for key advanced laparoscopic procedures.

AboutCardica
Cardicadesigns and manufactures proprietary stapling and anastomotic devices
for cardiac and laparoscopic surgical procedures.Cardica's technology
portfolio is intended to minimize operating time and enable minimally-invasive
and robot-assisted surgeries. Cardica manufactures and markets its automated
anastomosis systems, the C-Port^® Distal Anastomosis Systems and PAS-Port^®
Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery,
and has shipped over 46,400 units throughout the world. In
addition,Cardicais developing the Cardica^® MicroCutter XCHANGE™ 30, a
cartridge-based microcutter device with a five-millimeter shaft diameter, and
the Cardica^® MicroCutter XCHANGE™ 45, a cartridge-based microcutter device
with an eight-millimeter shaft. Both MicroCutter devices are designed to be
used in a variety of procedures, including bariatric, colorectal, thoracic and
general surgery. The Cardica MicroCutter XCHANGE 30 and XCHANGE 45 products
require 510(k) review and are not yet commercially available in the U.S.

Forward-Looking Statements

The statement in this press release that Cardica expects to introduce the
MicroCutter XCHANGE 30 to the U.S. market, pending approval by the FDA is a
"forward-looking statement." There are a number of important factors that
could cause Cardica's results to differ materially from those indicated by
these forward-looking statements, including: that Cardica may not be
successful in its efforts to further develop or commercialize the XCHANGE 30
due to unanticipated technical or other difficulties; that the XCHANGE 30 may
face unanticipated development, regulatory, or manufacturing delays; that
review by the FDA may require additional unanticipated submissions or actions
on the part of Cardica; that Cardica's intellectual property rights may not
provide adequate protection to enable further development of the XCHANGE 30;
that surgeons may not use the XCHANGE 30 correctly, which could cause
unfavorable results that may impair the acceptance of the XCHANGE 30 by other
surgeons; and that Cardica may not have sufficient funds to develop the
XCHANGE 30, as well as other risks detailed from time to time in Cardica's
reports filed with the U.S. Securities and Exchange Commission, including its
Current Report on Form 10-Q for the quarter endedMarch 31, 2013, under the
caption "Risk Factors." Cardica expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein. You are encouraged to read
Cardica's reports filed with the U.S. Securities and Exchange Commission,
available at www.sec.gov.

SOURCE Cardica, Inc.

Website: http://www.cardica.com
Contact: Bob Newell, Vice President, Finance and Chief Financial Officer,
(650) 331-7133, investors@cardica.com
 
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