Mazor Robotics Ltd. (TASE:MZOR), a developer of innovative surgical
robots and complementary products, today announced that its Korean
distributor, BR Holdings, received marketing clearance from the Korean
Food & Drug Administration (KFDA) to market Mazor's Renaissance™ system.
Renaissance is Mazor Robotics' surgical guidance system for spine
procedures. BR Holdings is a leading distributor of robotic surgery
technologies and instruments in Korea.
"Korean spine surgeons performed 120,000 cases in 2008, reflecting 18%
annual growth from 2003; per capita, it is the second largest spine
surgery market globally, and the country adopts new technologies with
enthusiasm," said Ori Hadomi, CEO of Mazor. "As an example, the Korean
healthcare system currently supports 36 da Vinci surgical robots. We
expect Korea to be a very strong market for our surgical robots and
serve as a gateway to the Asia Pacific region, as it has in the past for
other robotic technologies."
It is typical for the local distributor to take responsibility for
securing Korean regulatory clearances, and BR Holdings is also presently
pursuing reimbursement. In partnership with BR Holdings, Mazor will
immediately begin to market Renaissance to establish early adopters and
build local clinical experience.