REDWOOD CITY, Calif., April 6, 2011 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that the U.S. Patent and Trademark Office (USPTO) has issued the company Patent No. 7,918,376 for its proprietary Microcutter™ technology. This patent relates to the articulation of a surgical stapler or endocutter.
"The first patent covering our proprietary Microcutter technology to issue from a large portfolio of over 35 patent applications that have been filed in the U.S. and Europe protects our Microcutter technology related to articulation," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "Our Microcutter product line continues to move rapidly through development. With design validation of our initial commercial Microcutter device nearing completion, we expect first-in-man use in Europe in the first part of this quarter for the first device in this product line that we intend to commercialize, the Microcutter XPRESS™ 30."
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 in the Microcutter product line that we intend to commercialize, the Microcutter XPRESS™ 30, is 8 mm in diameter, compared to commercialized stapling products 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 anticipated Microcutter devices are designed to articulate to a greater degree than currently commercially available staplers. Additional planned iterations of the Microcutter product line include the Microcutter XCHANGE™ 30, with a shaft diameter of 5 mm, and the Microcutter FLEXCHANGE™ 30, with a flexible shaft, and are designed to enable port-access surgeries, including robot-assisted surgery, Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single-Incision Laparoscopic Surgery (SILS) interventions, all emerging surgical fields. All of Cardica's Microcutter products under development require regulatory clearance through the 510(k) or other process with the U.S. 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-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System, for coronary artery bypass graft (CABG) surgery and has shipped over 33,000 units throughout the world. In addition, Cardica is developing the Cardica Microcutter XPRESS™ 30, a true multi-fire endoscopic stapling device designed to be used in a variety of procedures, including bariatric, thoracic and general surgery. The Cardica Microcutter XPRESS™ 30 requires regulatory clearance through the 510(k) or other process with the U.S. 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 "expect," "intend," "anticipated," "planned" 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 complete the design verification necessary for first-in-man use of the Cardica Microcutter XPRESS™ 30 and initiate such use on the anticipated time frame; that Cardica may not be successful in its efforts to develop the Cardica Microcutter XPRESS™ 30 or any other microcutter products and 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 December 31, 2010. 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.|
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