Surgical devices maker Cardica’s (CRDC) has forged a distribution pact with Century Medical, a leading supplier of medical equipment in Japan, for its Microcutter product line. Tokyo-based Century Medical currently distributes Cardica’s PAS-Port proximal anastomosis (communication between blood vessels) system for coronary artery bypass graft (“CABG”) surgery in Japan.
Cardica is developing the Microcutter line of novel endoscopic stapling devices for use in a variety of surgeries that require cutting and stapling. The agreement provides Century Medical with exclusive rights to distribute the Microcutter products in Japan. Century Medical will be responsible for obtaining the approval of the Ministry of Health in Japan. Following the regulatory clearance, Cardica will sell its Microcutter products to Century Medical who would distribute them to customers in the island nation.
In exchange for the distribution rights, Century Medical has agreed to provide Cardica with a $4 million loan. Century’s obligation to offer the loan is contingent upon certain development milestones for the Microcutter devices which Cardica hopes to attain within the next several months. The company will use the loan to fund the ongoing development and commercialization activities across Europe and the U.S.
Cardica’s Microcutter product line has been geared to offer genuine multi-fire endoscopic stapling for a number of procedures, such as thoracic, colorectal as well as general surgery. The Microcutter line-up 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 is the first product in the Microcutter family which Cardica intends to market. The company recently completed the key internal design verification process for Microcutter XPRESS 30. Cardica’s Microcutter products are yet to be approved by the U.S. Food and Drug Administration (“FDA”).
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 CABG surgery and has sold over 36,000 units globally. Cardica competes with larger players such as Johnson & Johnson (JNJ) and Covidien (COV) in the laparoscopic stapling and sealing devices market.
