Cardica, Inc. (CRDC) F4Q12 Earnings Call August 2, 2012 4:30 p.m. ET Executives Robert Newell - Chief Financial Officer and Vice President, Finance Bernard Hausen - President, Chief Executive Officer and Co-Founder Analysts Akiva Felt - Wedbush Securities Ed Arce - McNicoll, Lewis & Vlak Presentation Operator
We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement. You are encouraged to read our reports filed with the SEC, available at www.sec.gov. This all is a property of Cardica and any rebroadcasting of this call without the express written permission of Cardica is prohibited.At this time I would like to turn the call to Bernard Hausen, Cardica’s President and CEO for corporate update. Bernard Hausen Thank you, Bob. Good afternoon, everyone. Thank you for joining us on our call today. Over the course of the last several months we have made tremendous progress on the path towards commercialization of our Cardica MicroCutter XCHANGE 30, a cartridge-based device with a 5-millimeter shaft diameter and articulation of up to 80 degrees. We announced last week that we have resumed the European clinical study of the MicroCutter and it is going very well. Prior to the resumption of the trial, more than 30 surgeons performed over 80 procedures with more than 250 deployments in total over the course of the last three months. MicroCutter has been used in appendectomies, intestinal resections, lung resections, vascular transections and a host of other gastrointestinal procedures. Already, surgeons have used the XCHANGE 30 to treat ten patients in or clinical trial. Many of these patients have been discharged and to date we are not aware of any serious adverse events associated with the use of the MicroCutter. One of the highlights of the last week was a seven-year old patient who needed an appendectomy. This procedure was performed flawlessly with the MicroCutter system, which allowed the surgeon to resect the appendix with our stapling device through a 5 mm trocar port. Avoiding larger torcars with their associated prevalence for surgical complications, pain and discomfort in children is considered when they have very appealing features of the MicroCutter XCHANGE 30. Therefore, as the MicroCutter is used by more surgeons, we believe there will be an increasing number of pediatric applications.
Other surgical applications that may benefit from the availability of the MicroCutter include vascular transaction, all forms of (inaudible) surgery including liver, kidney, spleen and lung resection. It is probably safe to assume that with this significant change in size and articulation, stapling may find its way into procedures where stapling is currently not an option today.In the ongoing clinical study, four sites have enrolled patients to date. Initially, our clinical plan is to limit the number of enrolling sites with approximately 30 surgeons trained to deploy the MicroCutter XCHANGE 30. Depending on the enrollment rate and the adequacy of patients of follow-up, according to the study protocol we have the ability to expand the number of enrolling sites to a total of ten. The study protocol calls for the enrollment of 160 patients followed for 30 days after their procedure. We expect to complete the clinical trial enrollment for protocol by the end of the calendar year. We may expand the sample size to approximately 200 patients to increase statistical power of the study. With this plans larger study sample size, we expect to complete enrollment in the first quarter of calendar 2013. We plan to use the clinical data from this trial for our 510(k) regulatory filing with the FDA in the second quarter of calendar year 2013. We anticipate that we will begin booking commercial sales with XCHANGE 30 in the second half of calendar 2012. We are increasing our manufacturing capacity for both XCHANGE 30 devices and cartridges in order to meet the demand of the clinical trial sites in our initial European commercial customers. Read the rest of this transcript for free on seekingalpha.com