Cardica, Inc. Updates Enrollment Progress in European Clinical Trial
Published: Feb 27, 2013
REDWOOD CITY, Calif., Feb. 27, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that 109 patients have been enrolled in the company's European clinical trial designed to evaluate the safety of its MicroCutter XCHANGE 30 cutting/stapling device in a variety of surgical procedures. Cardica plans to complete enrollment of 160 patients for the European clinical trial in the second calendar quarter of 2013.
"We are making progress with the MicroCutter XCHANGE 30 in Europe," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "In the last four weeks, we have enrolled an additional 19 patients in our clinical trial, with more scheduled in the days ahead. And, we continue to gain valuable feedback from European surgeons deploying the device in a variety of procedures, to prepare the device for broader distribution in the near future. To date the MicroCutter XCHANGE 30 device has been used in over 280 procedures and deployed more than 800 times."
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 44,100 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 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.
The statement in this press release regarding Cardica's plans to complete enrollment in the European clinical trial in the second quarter of calendar year 2013, 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 this forward-looking statement, including: that the XCHANGE 30 may face development, regulatory and manufacturing risks; 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 or otherwise delay completion of enrollment; and that Cardica may not have sufficient funds to complete enrollment in the clinical trial, 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 December 31, 2012. 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.