REDWOOD CITY, Calif. and TOKYO, Aug. 12, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) and Century Medical, Inc. today announced that Century Medical filed for regulatory approval of Cardica's MicroCutter XCHANGE 30 cutting and stapling cartridge in Japan. The submission to the Pharmaceuticals and Medical Devices Agency (PMDA) includes design, validation and verification data for the MicroCutter XCHANGE 30 cartridges. The XCHANGE 30 cartridges are used together with the XCHANGE 30 device to perform surgical procedures.
"We believe that the MicroCutter XCHANGE 30, with its small size and maneuverability, offers surgeons a significant advantage over conventional staplers," said Mr. Akira Hoshino, President and Chief Executive Officer of Century Medical, Inc. "We anticipate launching this revolutionary device in Japan during 2014."
"Century Medical is an ideal partner for Cardica in Japan, with surgical stapling expertise and product familiarity as our exclusive Japanese distributor for the PAS-Port® Proximal Anastomosis System," commented Bernard A. Hausen, M.D., Ph.D., President and Chief Executive Officer of Cardica. "We anticipate that Japan will become an important market for the MicroCutter XCHANGE 30 due to the focus of Japanese surgeons on less invasive procedures."
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.
Cardica designs 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, Cardica is 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.
The statements in this press release regarding the expectation that Century Medical looks forward to launching the MicroCutter XCHANGE 30 in Japan during 2014, and that Cardica anticipates that Japan will become an important market for the MicroCutter XCHANGE 30, pending approval by the PMDA, are "forward-looking statements." The words "expect," "anticipate" and "look forward" 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 due to unanticipated technical or other difficulties; that the XCHANGE 30 may face unanticipated development, regulatory, or manufacturing delays; that review by the PMDA may take longer than expected, or require additional unanticipated submissions or actions on the part of Cardica or Century Medical; 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 ended March 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.