Cardica Enrolls First Patients in European MicroCutter(TM) Clinical Study
REDWOOD CITY, Calif., Nov. 17, 2011 /PRNewswire/ — Cardica, Inc. (Nasdaq: CRDC) today announced that the first patients have been enrolled and discharged from the first two investigative sites in a European clinical study to evaluate its MicroCutter(TM) surgical cutting/stapling devices for transections, resections and anastomoses during gastrointestinal surgical procedures.
The planned MicroCutter product line is designed to provide true multi-fire and reloadable cartridge capabilities, with all MicroCutter devices designed to offer both stapling and cutting functionality. With low force-to-fire and small shaft diameters of eight millimeters for the MicroCutter(TM) XPRESS(TM) 30 device and five millimeters for the planned MicroCutter(TM) XCHANGE(TM) 30 device, the MicroCutter surgical stapling devices should provide flexibility and wide field access during laparoscopic surgical procedures.
“The MicroCutter surgical stapling technology, for the first time in over a decade, would move the field of surgical stapling forward with its innovative product size and design,” said Andreas Kuthe, M.D., chief of general surgery at the Red Cross Hospital Clementinenhaus, Hannover, Germany, and principal investigator of the trial. “The small shaft diameter and ability to reload the MicroCutter in situ may reduce tissue trauma and the invasiveness of the procedure while providing excellent patient outcomes.”
This prospective, single-arm, multi-center, non-inferiority clinical study is designed to assess the safety of the MicroCutter XPRESS 30 device and the planned XCHANGE 30 device (subject to Cardica’s ability to apply the CE Mark to the XCHANGE 30). MicroCutter surgical stapling devices will be used for transections, resections and anastomoses during gastrointestinal procedures. These results will be compared to historical adverse event reports for similar procedures performed with currently available stapling devices. Typical adverse events associated with current surgical staplers include staple line leakage, staple line bleeding, staple line strictures and surgical infections. Cardica plans to enroll up to 200 patients at up to 10 sites in Europe, with patients evaluated at the time of discharge and 30 days postoperatively.
“The initiation of this non-inferiority study represents a significant milestone for Cardica as we continue on the path toward planned commercialization of MicroCutter devices in the United States,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. “We expect enrollment to take approximately six months, and we plan to include the results of this study in a 510(k) submission to the U.S. Food and Drug Administration in the second half of calendar 2012.”
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-PortÃ‚® Distal Anastomosis Systems and PAS-PortÃ‚® Proximal Anastomosis System, for coronary artery bypass graft (CABG) surgery and has shipped over 37,000 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XPRESS 30, a true multi-fire laparoscopic stapling device designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter products require 510(k) review and are not yet commercially available in the U.S. The Cardica MicroCutter XCHANGE 30 is not yet commercially available.
This press release contains “forward-looking” statements, including all statements regarding the future conduct of the European clinical study and the continued development and planned features of, regulatory filings related to and approval and commercial launch of products in Cardica’s proposed MicroCutter product line, including 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 “planned,” “designed,” “should,” “may,” “subject to,” “will,” “plan,” “expect” 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’s European clinical study may not be completed on schedule, or at all; Cardica may not be successful in its efforts to complete the development and obtain regulatory approval of, and commercially launch, the Cardica MicroCutter product line on Cardica’s anticipated timeframe; that Cardica’s current and any future products may never gain any significant degree of market acceptance; that the planned MicroCutter 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; that Cardica requires substantial additional capital; and that general business and economic conditions may impair Cardica’s ability to market and develop products. These and other risks are detailed under the heading “Risk Factors” and elsewhere 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 September 30, 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.