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-- Results Validate "D" Shape Staple Used in Cardica's MicroCutter XCHANGE® 30 Enables 5-Millimeter and Potentially 3-Millimeter Surgical Stapler --
REDWOOD CITY, Calif., June 30, 2014 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that Dr. Stefanos Demertzis, associate professor at the University of Berne, Switzerland and senior staff cardiac surgeon and deputy head of the department of cardiac surgery at the Cardiocentro Ticino Lugano, completed a study that demonstrated that there was no difference in the chronic healing response between the innovative D-shaped staple design of the Cardica five-millimeter MicroCutter XCHANGE® 30 and the B-shaped staple design used in conventional 12-millimeter surgical staplers.
The results of the study, entitled "Beyond the "B": A New Concept of the Surgical Staple Enabling Miniature Staplers," were presented by Dr. Lee Swanstrom, chief innovations officer at the University of Strasbourg's University Hospitals Institutes, clinical professor of surgery for Oregon Health and Sciences University and medical director of Cardica, as part of the Amazing Technologies Session at the 14th Annual World Congress of Endoscopic Surgery in Paris, France, a meeting hosted by the European Association for Endoscopic Surgery (EAES) in conjunction with the SFCE (Societe Francaise de Chirurgie Endoscopique) and the International Society for Laparoscopic ColoRectal Surgery (ISLCRS). http://congress.eaes.eu/Home.aspx.
"All current staplers rely on the same staple form-the "B"-which is inherited from the common paper stapler," commented Dr. Demertzis. "This shape, while effective, necessitates a large delivery profile of at least 12 millimeters. Importantly, the D-shaped staple allows for a five millimeter surgical stapler today, and potentially a further reduction in size to three millimeters in the future. This is the first major advancement in the size of surgical staplers in nearly 30 years. With the smaller size of the MicroCutter, the D-staple, as well as the increased articulation, I believe this device will enable the advancement of minimally invasive surgery across the world."
The study compared the standard B-form staple, used in conventional 12-millimeter surgical staplers, to the innovative D-shaped staple used in the Cardica MicroCutter XCHANGE 30, the world's first and only five-millimeter surgical stapler that articulates to 80 degrees. Chronic histology performed showed that the D-shaped staple elicited a normal healing response with minimal inflammation and lack of excessive scar tissue formation. Further, there was no difference in the chronic healing response between "D" and "B" shaped staples.
"We are pleased to have the results of this study presented at the prestigious European Association for Endoscopic Surgery meeting, which brings together the key opinion leaders in minimally invasive surgery from around the world," said Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. "As the use of our MicroCutter XCHANGE 30 grows, this study validates the underlying technology necessary for the miniaturization of stapling devices and complements the recent selection of our device as a finalist in the Medical Design Excellence Awards."
Cardica designs and manufactures proprietary stapling and anastomotic devices for laparoscopic and cardiac surgical procedures. Cardica's technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica's MicroCutter XCHANGE® 30, a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter, is manufactured and cleared for use in a variety of gastrointestinal procedures and appendectomies in the United States, and is marketed for a wide range of surgical procedures in Europe. Cardica is developing the Cardica® MicroCutter XCHANGE® 45, a cartridge-based microcutter device that is being designed with an eight-millimeter shaft to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 45 product requires 510(k) clearance and CE Mark and is not yet commercially available in the U.S. or internationally. In addition, 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 50,000 units throughout the world.
The statement in this press release regarding the belief that the XCHANGE 30 will enable the advancement of minimally invasive surgery across the world is a "forward-looking statement." There are a number of important factors that could cause Cardica's results to differ materially from those indicated by this forward-looking statement, including: that Cardica may not be successful in its efforts to commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that prospective customers may not perceive the benefits of the XCHANGE 30 to be sufficient to warrant its purchase; that prospective customers may be constrained by pricing pressures or purchasing requirements in the hospitals and facilities in which they work, which could prevent them from purchasing the XCHANGE 30; the 3-mm surgical stapler is in the very early stages of development, and Cardica may encounter unexpected difficulties in developing a 3-mm surgical stapler and may determine not to develop a 3-mm surgical stapler for financial, technical or other reasons; 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 March 31, 2014, under the caption "Risk Factors," filed on May 7, 2014. 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.
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