Cardica (CRDC) recently obtained CE Mark certification for its initial Microcutter surgical cutting and stapling device. As part of the multiple step approval process, the company has received a Full Quality Assurance certification for the Microcutter’s design as well as manufacturing process.
Following receipt of this certification and upon conclusion of development activity, Cardica can apply its CE Mark to the first Microcutter product, the Microcutter XPRESS 30. It will also be able to use the CE Mark for forthcoming devices within the Microcutter line of products that comply with the authorized design and manufacturing processes.
Cardica believes that receipt of CE Mark for a preliminary Microcutter device is a major step in its progress towards the launch of its own staple-on-a-strip technology. The company anticipates successful launch of the Microcutter XPRESS 30 at European surgical centers. It then plans to conduct a partial release of the XPRESS 30 to about 20 to 30 surgeons in the U.S. in mid-2011, contingent upon the 510(k) clearance from the Food and Drug Administration (“FDA”).
Cardica’s Microcutter product line is intended to provide genuine multi-fire endoscopic stapling for a number of procedures, such as thoracic, colorectal as well as general surgery. The Microcutter lineup is expected to cut and staple on a continuous basis, thereby permitting the surgeon to complete consecutive deployments without removing the device to reload the cartridge.
The Microcutter XPRESS 30 has a diameter of only 8 millimeter (mm), compared to other commercialized stapling products, which have a diameter of 12 mm or above. The lesser diameter of the expected Microcutter lineup permits access through smaller-sized, less-intrusive ports and through trocars used for different surgical tools requisite for laparoscopic surgery.
Cardica manufactures stapling devices for endoscopic and cardiac surgery procedures. Its proprietary technology is designed to reduce operating time and enable minimally-invasive and robot-assisted surgeries. The company markets its automated anastomosis systems for coronary artery bypass graft (“CABG”) surgery and has sold over 33,000 units globally.
Cardica entered into a licensing pact with Intuitive Surgical (ISRG) in August 2010, under which the latter obtained the exclusive global license to Cardica’s intellectual property, related to tissue cutting, stapling and clip appliers for application in the robotics field. In return, Intuitive made an upfront license payment of $12 million and an equity investment of about 1.25 million shares of Cardica’s common stock. Cardica has used the license fee to repay all of its outstanding debt.
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