Cardica Announces Completion Of First U.S. Procedure Using MicroCutter XCHANGE™ 30 Stapling Device
REDWOOD CITY, Calif., March 11, 2014 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that Juan-Carlos Verdeja, M.D., F.A.C.S., completed the first surgical procedure in the United States using the MicroCutter XCHANGE™ 30 cutting and stapling device at West Kendall Baptist Hospital in Florida on March 3, 2014. The MicroCutter XCHANGE 30 is the only articulating five millimeter surgical stapler available today.
"The availability of the MicroCutter XCHANGE 30 in the U.S. has been a long time coming," said Dr. Verdeja, medical director of emergency surgical services for Baptist Health South Florida. "We have been waiting for a smaller stapler for decades and I believe having the MicroCutter at our disposal can change the way we perform some less invasive surgeries. The ability to use smaller and fewer access ports equates to less patient trauma, and improved articulation equates to more versatility. This appendectomy today was only one example of where I believe we will see the MicroCutter provide value. I am truly excited for our patients and the surgical community."
Cardica designs 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. Cardica is 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.
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 ended December 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.