Mazor Robotics Ltd., a developer of innovative guidance systems and complementary products, announced today that the China Food and Drug Administration (CFDA) has approved the Company's Renaissance® system, a state-of-the-art surgical guidance system that enables surgeons to conduct spine surgeries in an accurate and secure manner.
In addition to gaining the necessary regulatory approvals, the Company’s distribution partner in China, Cicel, has coordinated seminars and hands-on-lab experiences in the U.S. for China’s leading spine surgeons to learn about the Renaissance system and its clinical benefits. Cicel is based in Beijing and has six other offices throughout China helping to establish close relationships with surgeons, hospitals and other medical organizations.
“Receiving CFDA’s approval for marketing the Renaissance system in China is a significant achievement for Mazor, giving us access to a large and growing market opportunity,” commented Ori Hadomi, Chief Executive Officer. “China continues to adopt proven and state-of-the-art technologies to offer better patient outcomes, so we believe Renaissance is well-positioned to gain market acceptance. Our distribution partner, Cicel, believes the target market for Renaissance is in the hundreds of hospitals in China. Now, with the CFDA approval, our partner will initiate its marketing and sales process to introduce Renaissance to this important market. Cicel has the local market knowledge and expertise along with the sales, marketing and clinical organization to quickly raise awareness of the Renaissance system.”
Currently, Mazor has seven Renaissance systems installed throughout Asia, in India, Hong Kong, Taiwan, Singapore, Vietnam and Australia.
Mazor Robotics is dedicated to the development and marketing of innovative surgical guidance systems and complementary products that provide a safer surgical environment for patients, surgeons, and operating room staff. Mazor Robotics’ flagship product, Renaissance®, is a state-of-the-art surgical guidance system that enables surgeons to conduct spine surgeries in an accurate and secure manner. Mazor Robotics systems have been successfully used in the placement of over 50,000 implants worldwide. Numerous peer-reviewed publications and presentations at leading scientific conferences have validated the accuracy, usability, and clinical advantages of Mazor Robotics technology. For more information, the content of which is not part of this press release, please visit www.mazorrobotics.com.