Cardica Begins Shipping MicroCutter XCHANGE™ 30 Commercial Units For Europe

 Cardica Begins Shipping MicroCutter XCHANGE™ 30 Commercial Units For Europe

-- European Clinical Trial to Use Commercial Version of MicroCutter XCHANGE 30
--

PR Newswire

REDWOOD CITY, Calif., Dec. 26, 2012

REDWOOD CITY, Calif., Dec. 26, 2012 /PRNewswire/ --Cardica, Inc. (Nasdaq:
CRDC) today announced that it shipped its first commercial MicroCutter
XCHANGE™ 30 devices and cartridgesto DACH Medical Group, its distributor for
Germany, Austria and Switzerland. The MicroCutter XCHANGE 30 is the smallest
commercially-available, cartridge-based cutting/stapling device designed to be
used during laparoscopic and thoracoscopic surgical procedures.

The initial shipment of the XCHANGE 30 is intended to serve hospitals in
Switzerland and Austria. Approximately 60 surgeons have used the XCHANGE 30 in
over 220 laparoscopic and thoracoscopic procedures with more than 600
deployments over the last eight months. The MicroCutter XCHANGE 30 has been
used in a wide variety of surgical procedures including appendectomies,
gastric bypasses, hemicolectomies, gastrectomies, parenchymal or soft organ
surgeries (operations on the liver and kidney), lobectomies, and other
thoracic and lung surgeries. Recently, it has been used in hysterectomies as
well.

Based on the performance of the MicroCutter XCHANGE 30 to date, Cardica
believes the XCHANGE 30 is ready to be sold commercially. Cardica is
initiating European commercial sales in a well-controlled, focused sales
effort in parallel with data collection for a planned US regulatory
submission. Cardica will continue to make enhancements and improvements to the
MicroCutter XCHANGE 30 based on feedback from surgeons.

"Moving from development to commercialization of the XCHANGE 30 marks a
significant accomplishment for Cardica, and the beginning of a new phase of
growth. We continue to focus on ensuring each surgeon has positive and
successful experiences with our device," said Bernard A. Hausen, M.D. Ph.D.,
president and chief executive officer of Cardica, Inc. "We believe the XCHANGE
30 provides a technology advancement over larger stapler sizes which have
hindered further innovation in surgical procedures."

European Clinical Trial Update

In addition to beginning commercial efforts, Cardica will use the commercial
version of the XCHANGE 30 in the remaining patients enrolled in its European
clinical trial designed to support regulatory clearance of the XCHANGE 30 in
the United States. To date 90 patients have been enrolled. The company expects
enrollment to resume in January. Cardica has added two new sites for its
clinical trial in order to complete enrollment of 160 patients in the first
calendar quarter of 2013, as expected. 

About the MicroCutter XCHANGE 30: The World's First and Only Five Millimeter
Stapler

The MicroCutter XCHANGE 30 is a minimally-invasive stapling device designed to
be used in laparoscopic and thoracoscopic surgical procedures. Its small,
five-millimeter shaft diameter and range of motion up to 80 degrees of
articulation differentiate the XCHANGE 30 from other commercially-available
staplers. The device uses reloadable cartridges with a 30-millimeter staple
line length. The cartridge comes with either blue staples, for medium tissue
thicknesses, or white staples, for thin tissues such as vascular structures.

Laparoscopic procedures today are primarily performed through trocars ports,
or small tubes inserted into incisions, that are between five and 10
millimeters in diameter. Prior to the introduction of the XCHANGE 30, to
accommodate conventional stapling technology surgeons use 12 or 15 mm trocars,
which can result in significant post-operative pain, port site infections or
ventral hernias. The small size of the XCHANGE 30 may reduce the amount of
tissue dissection necessary to position the stapler for deployment and may
greatly improve access and visualization at the stapling site. The smaller
diameter and much greater articulation, or range of motion, of the XCHANGE 30
are designed to allow easier access through smaller, less-invasive ports, and
to enable faster and easier access to reach difficult anatomy during 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 42,900 units throughout the world. In
addition,Cardicais developing the Cardica MicroCutter XCHANGE™ 30, a
cartridge-based microcutter device with a five-millimeter shaft diameter that
is commercially available in the European Union, and the Cardica MicroCutter
XPRESS™ 30, a true multi-fire laparoscopic stapling device. 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 XPRESS 30 products require 510(k) review and are not yet
commercially available in the U.S.

Forward-Looking Statements

The statements in this press release regarding the intended use of initial
shipments of the XCHANGE 30, Cardica's belief that the XCHANGE 30 is ready to
be sold commercially, that it is beginning of a new phase of growth, its
intention to continue to make enhancements and improvements to the MicroCutter
XCHANGE 30, its plans to add two new sites for its European clinical trial and
commence enrollment in the clinical trial in January 2013 and complete
enrollment in the first quarter of 2013, its intention to continue to be
focused on ensuring each surgeon has a positive and successful experience with
the device, and the benefits of the small size of the XCHANGE 30, are
"forward-looking statements." The words "intend," "will," "believe," "may" and
"plan" and derivations of these words are intended to identify these
forward-looking statements. 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 or its planned
MicroCutter product line on its anticipated timeframe, or at all, due to
regulatory, technical, manufacturing or financial difficulties; that Cardica
products may face development, regulatory, reimbursement and manufacturing
risks; that Cardica's intellectual property rights may not provide adequate
protection; and that general business and economic conditions may impair
Cardica's ability to market and develop products, or raise additional funds
needed to complete development, 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 Quarterly Report on Form 10-Q for the quarter
endedSeptember 30, 2012. Cardica expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein. Investors are encouraged to read
Cardica's reports filed with the U.S. Securities and Exchange Commission,
available at www.sec.gov.

SOURCE Cardica, Inc.

Contact: Bob Newell, Vice President, Finance and Chief Financial Officer,
+1-650-331-7133, investors@cardica.com
 
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