Mazor Robotics' Surgical System Receives Key Regulatory Approval
In January, Mazor Robotics Ltd. received two regulatory nods in quick succession for its Renaissance surgical system. First, Health Canada (HC) gave the go-ahead for the system, and then Taiwan followed suit. The U.S. Food and Drug Administration cleared Renaissance for sale in the United States in July last year.
According to company officials, the goal for Renaissance is for it to move spine surgery away from freehand methods to automated, highly accurate robotic methods. The system is intended for use in minimally invasive surgery, scoliosis, and other complex spinal deformity cases.
The HC license encompasses Renaissance’s use in both spine and brain applications, subject to specifications outlined in the clearance documents. The company plans to begin marketing the Renaissance technology through distributor partnerships this year.
“The receipt of the HC license is an important step in securing our foothold in North America,” said CEO Ori Hadomi. “We made significant progress expanding in the U.S. in 2012, and we have begun 2013 with the intent to further our growth and bring our innovative technology to new markets. Canada is a key geography for spine and brain applications, and we are excited to provide our Renaissance technology to the patients of Canada.”
Pinnaclemed Co. Ltd. will distribute and market the Renaissance technology in Taiwan on behalf of Mazor. Renaissance is already on the Asia Pacific market (through distribution partners) in several countries including Japan, China, Korea, India, Singapore, Vietnam and Australia.
“As part of our strategic global growth strategy, we are pleased to build on the base we have established in Asia,” added Hadomi. “We made great inroads into the Asia Pacific region in 2012 and believe it offers strong growth opportunities for Mazor in the coming years.”
Mazor is based in Caesarea, Israel. The company develops surgical robots and complementary products,