Cardica Updates Recruitment For European Clinical Trial Of MicroCutter(TM) Cutting And Stapling Device
REDWOOD CITY, Calif., Oct. 4, 2012 /PRNewswire/ — Cardica, Inc. (Nasdaq: CRDC) today announced that it has enrolled 68 out of 160 total patients in its European clinical trial. The study is designed to evaluate the safety and efficacy of Cardica’s MicroCutter(TM) XCHANGE(TM) 30 cutting/stapling device in a variety of gastrointestinal surgical procedures including transections, resections and anastomoses.
“We are pleased to report that our clinical trial continues to enroll quickly with a total of 153 deployments in 68 patient procedures to date with the MicroCutter XCHANGE 30 device,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. “Concurrently, preparations for our selective commercial launch in Europe continue to go well. We look forward to bringing our MicroCutter XCHANGE 30, with its small shaft diameter and wide range of articulation, to selected surgical centers in Europe in the current quarter.”
The prospective, single-arm, multi-center, non-inferiority clinical study is designed to assess the safety of the MicroCutter XCHANGE 30 device and planned XPRESS 30 device (subject to completing product development). The results of these procedures 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 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 41,500 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE(TM) 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, and the Cardica MicroCutter XPRESS(TM) 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 XCHANGE 30 and XPRESS 30 products require 510(k) review and are not yet commercially available in the U.S.
This press release contains “forward-looking statements” including all statements regarding the commercial launch, sales, continued development, regulatory approval and commercialization of products in Cardica’s proposed MicroCutter product line, including the MicroCutter XCHANGE 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 “moving forward,” “intend,” “will,” 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 be successful in its efforts to further develop or commercialize the MicroCutter XCHANGE 30; that the European clinical trial may not be completed on schedule, or at all, due to events or difficulties in the development of the MicroCutter products or otherwise; that Cardica may not initiate commercial sales for the MicroCutter XCHANGE 30 in 2012, or at all; that Cardica may not complete the development of its planned MicroCutter product line on its anticipated timeframe, or at all, due to regulatory, technical, manufacturing or financial difficulties; 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 to maintain sales in the cardiac business; 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 Annual Report on Form 10-K for the year ended June 30, 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.