Cardia, Inc. Halts Enrollment in EU Trial of Surgical Device
1/13/2012 8:55:02 AM
REDWOOD CITY, Calif., Jan. 12, 2012 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced the suspension of enrollment in its European clinical trial of the MicroCutter XPRESS 30 due to a small subset of deployments where the XPRESS 30 did not perform satisfactorily in thicker tissue. The company has isolated the underlying cause, which requires modifications to the product. There have been no serious adverse events and all patients have had an uneventful postoperative course as it relates to the use of the MicroCutter.
Cardica has reprioritized the development activities of its MicroCutter product line to emphasize the development of the MicroCutter XCHANGE 30. In addition to the acceleration of development for the XCHANGE 30, the company intends to pursue modifications of the XPRESS 30 concurrently. Cardica plans to continue the trial with the XCHANGE 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, by the end of the first calendar quarter of 2012, once this device completes development and design verification, and Cardica is able to apply Conformite Europeenne (CE) Mark to the device.
The surgical indications for the trial will not change, with thicker tissue resections and anastomosis intended to be added in the latter part of the trial once the XPRESS 30 modifications have been completed and verified. In light of Cardica's limited financial resources, Cardica has suspended development of other potential products in its planned microcutter product line until the development of XCHANGE 30 has been completed and additional financial resources have been obtained.
"We are disappointed that the XPRESS 30 did not perform as well as we expected in the upper range of tissue thickness but understand and are confident we can make the changes needed to enhance performance. In the interim, the XCHANGE 30 will allow us to resume trial enrollment in the near future while also providing Cardica with a readily marketable product that is substantially smaller with significantly enhanced articulation range," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "At this time, we believe that rapidly advancing our smallest, cartridge-based device, the XCHANGE 30, through development and into a clinical trial, while addressing the underlying issue with the XPRESS 30, will allow us to reach the European and US markets with our premier product in the most efficient manner."
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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 37,000 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, and 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 and XPRESS 30 are not currently commercially available.
This press release contains "forward-looking" statements, including all statements regarding the further development of Cardica's MicroCutter product line and product introduction, the anticipated timing of recommencement and the anticipated structure of its clinical trial, and the anticipated benefits of reprioritizing its development on the XCHANGE 30. The words "will," "plans," "intends," "believe" 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 the European clinical trial may not be commenced or completed on schedule, or at all, due to events or difficulties in the development of the microcutter products; that Cardica may not complete the development of, obtain regulatory approval of, and commercially launch, any products in 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 Cardica's sales, marketing and distribution strategy and capabilities may not be sufficient or successful; that Cardica requires substantial additional capital which, if not obtained, may prevent it from completing the development and commercialization of its microcutter products; 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 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.