CAESAREA, Israel, Mar 12, 2012 (BUSINESS WIRE) — –Distributor Responsible for Securing Regulatory Clearance in China
Mazor Robotics Ltd (tase:MZOR), the leader in innovative surgical robots and complementary products for spine surgery, signed an agreement with Cicel Science & Technology Co., Ltd. to distribute its Renaissance(TM) system in China. Renaissance is Mazor Robotics’ next generation surgical guidance system for spine procedures.
As part of the agreement, Cicel is committed to purchasing three Renaissance systems. Cicel will use these systems to pursue regulatory clearance for Renaissance from the State Food and Drug Administration (SFDA) in China and to establish marketing activities in China. Cicel will be responsible for securing the necessary regulatory clearance, which Mazor expects will take two years. Cicel will have exclusive rights to market and distribute the system in China for three years following the receipt of SFDA clearance. Mazor has received a first installment on account of the total consideration for the systems from Cicel. The delivery of the three Renaissance systems is subject to fulfillment of preset conditions.
“We are excited about our partnership with Mazor Robotics as we see great market potential for spinal robotics in China,” said Mrs. May Lee, General Manager of Cicel Ltd. “The Chinese medical market is advancing rapidly, adopting state-of-the-art technologies and striving to offer clinical care of the highest quality.”
Based in Beijing since 1996, Cicel is a leading distributor of advanced medical devices in China, specializing in products for orthopedic and spinal surgery, endoscopy, and general surgery, among other specialties. Cicel’s other partners include Integra, a U.S.-based manufacturer of devices and implants for orthopedic surgery; Schaerermedical, the Swiss provider of surgical tables, equipment and accessories; and in Germany, Condor GmbH Medicaltechnic, manufacturer of surgical retractors and other instruments.
“Local representation is key to a successful relationship with the SFDA and to establishing a presence in the marketplace, and Cicel is the best possible partner for Mazor,” said Ori Hadomi, CEO of Mazor Robotics. “Cicel has established relationships with the top hospitals and medical organizations in China, and in addition to its extensive sales and marketing capability Cicel has a full clinical organization with a solid track record for securing regulatory clearance. We are extremely excited to establish our foothold in this key global market with Cicel as our partner.”
About Mazor Robotics
Mazor Robotics Ltd (tase:MZOR) is dedicated to the development and marketing of innovative surgical robots and complementary products that provide a safer surgical environment for patients, surgeons, and OR staff. Mazor Robotics’ flagship product, Renaissance(TM), 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 15,000 implants in the USA and Europe. 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, visit www.mazorrobotics.com
SOURCE: Mazor Robotics Ltd