Healthcare Industry News: anastomosis system
News Release - June 6, 2012
Cardica Reports Progress With MicroCutter XCHANGE(TM) 30 In Europe100 Deployments Completed in 35 Cases
European Commercial Sales Expected in Calendar 3Q12
REDWOOD CITY, Calif., June 6, 2012 -- (Healthcare Sales & Marketing Network) -- Cardica, Inc. (CRDC) today reported that its MicroCutter XCHANGE™ 30, a cartridge-based cutting and stapling device with a five millimeter shaft diameter, has been used successfully during the last two months in over 100 deployments during more than 35 surgical procedures at six separate hospitals in Germany.
The XCHANGE 30 has been used in a variety of procedures including appendectomies, large and small bowel procedures, gastrectomies, as well as various types of lung resections. The procedures were performed by 14 different surgeons in a combination of laparoscopic and open techniques. All patients were discharged with no adverse events related to the XCHANGE 30.
"The XCHANGE 30 with its small shaft diameter and versatility, especially during thoracoscopic lung procedures, is a great advancement in stapling technology," said Dr. Albert Linder, chief of thoracic surgery at the Bremen Ost Hospital in Germany. "This device reduces the amount of necessary tissue dissection and thereby reduces the risk of vessel injury and bleeding, substantially reduces the need for larger trocars and due to the large degree of articulation, improves access within the thoracic cavity."
"We have performed a number of appendectomies with the XCHANGE 30 using only 5 mm trocar ports, thereby reducing the invasiveness, pain and discomfort and improving cosmesis," said Dr. Haemmerle from the Sana Klinikum in Hameln, Germany.
Based on the success of the initial deployments and feedback from the surgeons performing the procedures, Cardica continues to make modifications to the XCHANGE 30 in its effort to ensure consistent reliability prior to resuming the clinical study to support its U.S. regulatory submission. Subsequent to resuming the trial, which the company expects will be in late June or early July, Cardica expects to book commercial sales in the third quarter of calendar 2012.
Cardica is now validating that the modifications to the XCHANGE 30 work as expected in clinical practice. Concurrent with this effort, Cardica continues site training and certification so that patient enrollment for the clinical trial can begin after Cardica verifies reliable product performance.
"We are very pleased with the performance and positive response we've received to date from the initial procedures using the XCHANGE 30," commented Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "We have seen staple line consistency and quality, and moving forward, in order to expand our experience base, we will continue to deploy the XCHANGE 30 at every appropriate opportunity at our six trained sites."
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 40,000 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 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 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 XCHANGE 30; that the European clinical trial may not be resumed or 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 XCHANGE 30 in Calendar 3Q12, 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 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.
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