Mazor Robotics Ltd. (TASE:MZOR) today announced that it has obtained US Food and Drug Administration (FDA) approval for its Renaissance surgical guidance system for brain surgery, in addition to spinal procedures. The company will include the brain surgical capability in the same device currently sold for spinal procedures.
Mazor CEO Ori Hadomi has said in the past that Mazor is a company operating in the spinal procedures field, and that it expected to remain so. The expansion to the brain surgical field is an important addition, but not a core business.
Mazor has previously said that the addition of new capabilities to the Renaissance surgical guidance system could allow the company to raise the system's price, which is currently $750,000 per unit for the spinal surgery version.
Mazor had NIS 9.2 million in sales for the first quarter of 2012. Since April, the company has announced the sale of five additional systems in the US. The company also operates in other countries, where prices for its systems are a bit less than in the US, but the number of sales is about the same. The company obtained marketing approval in South Korea in June.
Mazor is now waiting for EU CE Mark approval for the marketing of the Renaissance system for brain surgery in Europe, where it is currently limited to use for spinal surgical procedures.
Mazor's share price rose 10.6% by mid-afternoon to NIS 4.70, giving a market cap of NIS 101 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 16, 2012
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