REDWOOD CITY, Calif., Dec. 11, 2013 /PRNewswire/ -- Cardica, Inc. (CRDC) today announced the commercial availability of the white cartridge for its MicroCutter XCHANGE™ 30 in Europe. Following extensive product testing to confirm reliability and functionality, Cardica shipped its initial commercial batches of white cartridges to its European distributors. The white cartridge is designed to be used with the MicroCutter XCHANGE 30 to staple blood vessels and other small tissue structures during open and laparoscopic surgical procedures.
"Our team worked tirelessly to develop, test and retest the white cartridge prior to shipping to our commercial accounts," said Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. "The achievement of this milestone opens up the market opportunity for Cardica, as the XCHANGE 30 is now ideally suited to facilitate a wide range of surgical procedures including pediatric cases, and resections and transections of numerous organs."
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 47,700 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 statement in this press release regarding Cardica's belief that the availability of the white cartridge opens up the market opportunity for Cardica 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
- Health Care Industry