Cardica Applies CE Mark to Microcutter XPRESS(TM) 30 Surgical Cutting and Stapling Device
REDWOOD CITY, Calif., June 30, 2011 /PRNewswire/ — Cardica, Inc. (Nasdaq: CRDC) today announced that it has completed the internal design verification process for its proprietary Microcutter XPRESS(TM) 30 surgical cutting and stapling device necessary to apply the CE Mark to this product for commercial use in Europe. Cardica plans to initiate first-in-man use of the XPRESS 30 in selected European centers starting in July.
“Our internal verification process is both rigorous and comprehensive, intended to comply with all regulatory requirements in the United States and Europe. We are pleased to have successfully accomplished this critical step toward the commercialization of our XPRESS 30 device in Europe,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. “With this milestone complete, we have scheduled several laparoscopic cases in Europe using the XPRESS 30, our first true multi-fire microcutter device that we plan to commercialize.”
About Cardica’s Microcutter Product Line
Cardica’s Microcutter surgical cutting and stapling product line is designed to provide true multi-fire endoscopic stapling in a variety of procedures, including colorectal, thoracic and general surgery. The Microcutter product line is designed to cut and staple continuously, allowing a surgeon to complete successive deployments without removing the device for a cartridge reload. The first device that Cardica intends to commercialize in its Microcutter product line, the Microcutter XPRESS(TM) 30, has a shaft that is 8 mm in diameter, compared to commercialized stapling products with shafts that are at least 12 mm in diameter. The smaller diameter of the anticipated Microcutter line allows access through smaller, less-invasive ports and, importantly, through trocars used for the other surgical tools required for laparoscopic procedures. All of Cardica’s Microcutter products under development require regulatory clearance through the 510(k) with the Food & Drug Administration and are not yet commercially available in the U.S.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and endoscopic 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-PortÃ‚® Distal Anastomosis Systems and PAS-PortÃ‚® Proximal Anastomosis System, for coronary artery bypass graft (CABG) surgery and has shipped over 34,500 units throughout the world. In addition, the company is developing the Cardica Microcutter XPRESS(TM) 30, a true multi-fire endoscopic stapling device designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica Microcutter XPRESS 30 requires a 510(k) review with the Food & Drug Administration and is not yet commercially available in the U.S.
This press release contains “forward-looking” statements, including all statements regarding the future development, first-in-man use, potential surgical uses, regulatory approval and commercialization of products in Cardica’s proposed Microcutter product line, including the Cardica Microcutter XPRESS 30, and the timing thereof. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words “plans,” “scheduled,” “to be” and similar expressions are intended to identify 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 initiate first in man use of the Cardica Microcutter XPRESS 30 within Cardica’s anticipated time frame; that Cardica may not be successful in its efforts to develop any other microcutter products or to expand its product portfolio; that the Microcutter XPRESS 30 may not be subject to a 510(k) rather than longer Premarket Approval application process or otherwise may not obtain U.S. regulatory approval on Cardica’s anticipated timeline, if at all; that Cardica’s current and any future products may never gain any significant degree of market acceptance; that any future Cardica products face development, regulatory, reimbursement and manufacturing risks; that Cardica’s intellectual property rights may not provide adequate protection; that Cardica’s sales, marketing and distribution strategy and capabilities may not be sufficient or successful; and that general business and economic conditions may impair Cardica’s ability to market and develop products, 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 fiscal quarter ended March 31, 2011. 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.