Redwood City, Calif.-based Cardica sent in the cartridge design validation application to Japan’s Pharmaceuticals & Medical Devices Agency today.
Century Medical CEO Akira Hoshino was confident about the application’s fate in a press statement, saying he anticipates a launch next year. The Japanese distribution company has an existing deal with Cardica for its PAS-port proximal anastomosis system.
"Century Medical is an ideal partner for Cardica in Japan," said Cardica CEO Dr. Bernard Hausen in the statement. "We anticipate that Japan will become an important market for the MicroCutter Xchange 30 due to the focus of Japanese surgeons on less invasive procedures."
After a disappointing 4th quarter and an almost 20% increase in full-year losses over 2012, Cardica is banking on the MicroCutter line. The company just wrapped up clinical trials in Europe and plans to submit a FDA 510(k) this week, according to Hausen’s comment’s to investors.