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Cardica's CEO Discusses F4Q12 Results - Earnings Call Transcript

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.

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