From the Wires
Cardica Begins Shipping MicroCutter XCHANGE™ 30 Commercial Units For Europe
-- European Clinical Trial to Use Commercial Version of MicroCutter XCHANGE 30 --
By: PR Newswire
Dec. 26, 2012 04:58 PM
REDWOOD CITY, Calif., Dec. 26, 2012 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it shipped its first commercial MicroCutter XCHANGE™ 30 devices and cartridges to DACH Medical Group, its distributor for Germany, Austria and Switzerland. The MicroCutter XCHANGE 30 is the smallest commercially-available, cartridge-based cutting/stapling device designed to be used during laparoscopic and thoracoscopic surgical procedures.
The initial shipment of the XCHANGE 30 is intended to serve hospitals in Switzerland and Austria. Approximately 60 surgeons have used the XCHANGE 30 in over 220 laparoscopic and thoracoscopic procedures with more than 600 deployments over the last eight months. The MicroCutter XCHANGE 30 has been used in a wide variety of surgical procedures including appendectomies, gastric bypasses, hemicolectomies, gastrectomies, parenchymal or soft organ surgeries (operations on the liver and kidney), lobectomies, and other thoracic and lung surgeries. Recently, it has been used in hysterectomies as well.
Based on the performance of the MicroCutter XCHANGE 30 to date, Cardica believes the XCHANGE 30 is ready to be sold commercially. Cardica is initiating European commercial sales in a well-controlled, focused sales effort in parallel with data collection for a planned US regulatory submission. Cardica will continue to make enhancements and improvements to the MicroCutter XCHANGE 30 based on feedback from surgeons.
"Moving from development to commercialization of the XCHANGE 30 marks a significant accomplishment for Cardica, and the beginning of a new phase of growth. We continue to focus on ensuring each surgeon has positive and successful experiences with our device," said Bernard A. Hausen, M.D. Ph.D., president and chief executive officer of Cardica, Inc. "We believe the XCHANGE 30 provides a technology advancement over larger stapler sizes which have hindered further innovation in surgical procedures."
European Clinical Trial Update
In addition to beginning commercial efforts, Cardica will use the commercial version of the XCHANGE 30 in the remaining patients enrolled in its European clinical trial designed to support regulatory clearance of the XCHANGE 30 in the United States. To date 90 patients have been enrolled. The company expects enrollment to resume in January. Cardica has added two new sites for its clinical trial in order to complete enrollment of 160 patients in the first calendar quarter of 2013, as expected.
About the MicroCutter XCHANGE 30: The World's First and Only Five Millimeter Stapler
The MicroCutter XCHANGE 30 is a minimally-invasive stapling device designed to be used in laparoscopic and thoracoscopic surgical procedures. Its small, five-millimeter shaft diameter and range of motion up to 80 degrees of articulation differentiate the XCHANGE 30 from other commercially-available staplers. The device uses reloadable cartridges with a 30-millimeter staple line length. The cartridge comes with either blue staples, for medium tissue thicknesses, or white staples, for thin tissues such as vascular structures.
Laparoscopic procedures today are primarily performed through trocars ports, or small tubes inserted into incisions, that are between five and 10 millimeters in diameter. Prior to the introduction of the XCHANGE 30, to accommodate conventional stapling technology surgeons use 12 or 15 mm trocars, which can result in significant post-operative pain, port site infections or ventral hernias. The small size of the XCHANGE 30 may reduce the amount of tissue dissection necessary to position the stapler for deployment and may greatly improve access and visualization at the stapling site. The smaller diameter and much greater articulation, or range of motion, of the XCHANGE 30 are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to reach difficult anatomy during advanced laparoscopic procedures.
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 42,900 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 that is commercially available in the European Union, 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 statements in this press release regarding the intended use of initial shipments of the XCHANGE 30, Cardica's belief that the XCHANGE 30 is ready to be sold commercially, that it is beginning of a new phase of growth, its intention to continue to make enhancements and improvements to the MicroCutter XCHANGE 30, its plans to add two new sites for its European clinical trial and commence enrollment in the clinical trial in January 2013 and complete enrollment in the first quarter of 2013, its intention to continue to be focused on ensuring each surgeon has a positive and successful experience with the device, and the benefits of the small size of the XCHANGE 30, are "forward-looking statements." The words "intend," "will," "believe," "may" and "plan" and derivations of these words are intended to identify these 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 XCHANGE 30 or its planned MicroCutter product line on its anticipated timeframe, or at all, due to regulatory, technical, manufacturing or financial difficulties; that Cardica products may face development, regulatory, reimbursement and manufacturing risks; that Cardica's intellectual property rights may not provide adequate protection; and that general business and economic conditions may impair Cardica's ability to market and develop products, or raise additional funds needed to complete development, 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 September 30, 2012. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. Investors are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
SOURCE Cardica, Inc.
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