|By PR Newswire||
|December 26, 2012 04:58 PM EST||
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.
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Aug. 31, 2015 04:00 AM EDT Reads: 396
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
Aug. 31, 2015 04:00 AM EDT Reads: 218
It’s been proven time and time again that in tech, diversity drives greater innovation, better team productivity and greater profits and market share. So what can we do in our DevOps teams to embrace diversity and help transform the culture of development and operations into a true “DevOps” team? In her session at DevOps Summit, Stefana Muller, Director, Product Management – Continuous Delivery at CA Technologies, answered that question citing examples, showing how to create opportunities for ...
Aug. 31, 2015 03:00 AM EDT Reads: 479
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Aug. 31, 2015 02:00 AM EDT Reads: 447
SYS-CON Events announced today that DataClear Inc. will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The DataClear ‘BlackBox’ is the only solution that moves your PC, browsing and data out of the United States and away from prying (and spying) eyes. Its solution automatically builds you a clean, on-demand, virus free, new virtual cloud based PC outside of the United States, and wipes it clean...
Aug. 30, 2015 11:45 PM EDT Reads: 395
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Aug. 30, 2015 10:00 PM EDT Reads: 344
Any Ops team trying to support a company in today’s cloud-connected world knows that a new way of thinking is required – one just as dramatic than the shift from Ops to DevOps. The diversity of modern operations requires teams to focus their impact on breadth vs. depth. In his session at DevOps Summit, Adam Serediuk, Director of Operations at xMatters, Inc., will discuss the strategic requirements of evolving from Ops to DevOps, and why modern Operations has begun leveraging the “NoOps” approa...
Aug. 30, 2015 06:45 PM EDT Reads: 369
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
Aug. 30, 2015 05:00 PM EDT Reads: 133
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Aug. 30, 2015 05:00 PM EDT Reads: 464
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Aug. 30, 2015 04:00 PM EDT Reads: 153
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of tech...
Aug. 30, 2015 01:30 PM EDT Reads: 223
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Aug. 30, 2015 01:30 PM EDT Reads: 190
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Aug. 30, 2015 01:00 PM EDT Reads: 287
SYS-CON Events announced today the Containers & Microservices Bootcamp, being held November 3-4, 2015, in conjunction with 17th Cloud Expo, @ThingsExpo, and @DevOpsSummit at the Santa Clara Convention Center in Santa Clara, CA. This is your chance to get started with the latest technology in the industry. Combined with real-world scenarios and use cases, the Containers and Microservices Bootcamp, led by Janakiram MSV, a Microsoft Regional Director, will include presentations as well as hands-on...
Aug. 30, 2015 12:00 PM EDT Reads: 270
Cloud and datacenter migration innovator AppZero has joined the Microsoft Enterprise Cloud Alliance Program. AppZero is a fast, flexible way to move Windows Server applications from any source machine – physical or virtual – to any destination server, in any cloud or datacenter, using its patented container technology. AppZero’s container is also called a Virtual Application Appliance (VAA). To facilitate Microsoft Azure onboarding, AppZero has two purpose-built offerings: AppZero SP for Azure,...
Aug. 30, 2015 11:00 AM EDT Reads: 175