Cardica Receives 510(k) Clearance For Both MicroCutter XCHANGE™ 30 White Cartridge And New Material

   Cardica Receives 510(k) Clearance For Both MicroCutter XCHANGE™ 30 White
                          Cartridge And New Material

PR Newswire

REDWOOD CITY, Calif., Feb. 27, 2014

REDWOOD CITY, Calif., Feb. 27, 2014 /PRNewswire/ --Cardica, Inc. (Nasdaq:
CRDC) today announced it received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its MicroCutter XCHANGE™ 30 white cartridge for the
stapling of thin tissue for use in multiple open or minimally-invasive
surgical procedures for the transection, resection and/or creation of
anastomoses in small and large intestine, as well as the transection of the
appendix. In addition, Cardica obtained 510(k) clearance for an additional
plastic material contained within the MicroCutter XCHANGE 30 blue cartridge
for use in medium thickness tissue. This material was submitted as a Special
Premarket Notification 510(k) for the MicroCutter XCHANGE 30 device, which
received FDA clearance in January 2014. With these clearances received Cardica
does not have any other submissions pending at the FDA.

"My patients will benefit from the significant advances in stapling technology
offered by the 5mm XCHANGE 30," said Mark Wulkan, M.D., professor of surgery
and chief of the division of pediatric surgery at Emory University School of
Medicine and surgeon-in-chief of Children's Healthcare of Atlanta. "The small
size sets the XCHANGE 30 apart from other surgical stapling technologies
available, meeting the need for less invasive surgical tools for my patients.
I see a particular need for this technology in bowel resections in small
patients."

AboutCardica
Cardicadesigns and manufactures proprietary stapling and anastomotic devices
for cardiac and laparoscopic surgical procedures.Cardica's technology
portfolio is intended to reduce operating time and facilitate
minimally-invasive and robot-assisted surgeries. Cardica's MicroCutter
XCHANGE™ 30, a cartridge-based articulating surgical stapling device with a
five-millimeter shaft diameter, is manufactured and cleared for use in a
variety of gastrointestinal procedures and appendectomies in the United
States, and is marketed for a wide range of surgical procedures in Europe.
Cardicais developing the Cardica^® MicroCutter XCHANGE™ 45, a cartridge-based
microcutter device with an eight-millimeter shaft to be used in a variety of
procedures, including bariatric, colorectal, thoracic and general surgery. The
Cardica MicroCutter XCHANGE 45 product requires 510(k) review and CE Mark and
is not yet commercially available in the U.S. or internationally. In addition,
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 49,000
units throughout the world.

Forward-Looking Statements
The statements in this press release regarding the benefits expected for
patients from Cardica's MicroCutter XCHANGE 30 and cartridges are
"forward-looking statements." There are a number of important factors that
could cause Cardica's results to differ materially from those indicated by
this forward-looking statement, including: that Cardica may not be successful
in its efforts to commercialize the XCHANGE 30 due to unanticipated technical
or other difficulties; that prospective customers in the United States may not
perceive the benefits of the XCHANGE 30 to be sufficient to warrant its
purchase; that prospective customers in the United States may be constrained
by pricing pressures or purchasing requirements in the hospitals and
facilities in which they work, which could prevent them from purchasing 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
Quarterly Report on Form 10-Q for the quarter endedDecember 31, 2013, under
the caption "Risk Factors," filed on February 5, 2014. 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.

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