Mazor Robotics Ltd. announced Monday that three procedures for obtaining brain
tissue biopsies were successfully carried out in Germany using the company’s
robotic system.
The procedures were carried out on live patients, in
contrast to the previous clinical trials on cadavers. The three procedures were
carried by two different neurosurgeons at HSK Hospital in Weisbaden.
In
the expert opinion of the surgeons, the procedures were a complete
success.
Mazor said that the biopsies demonstrated the precision,
stability, ease of use and high safety profile of the robotic
system.
Mazor is expanding the applications of its robotic navigation
system to brain surgery from its original use in spinal procedures. The company
is planning the commercial launch of the system for neurosurgery in early 2013,
after additional biopsies are carried out on live patients to optimize the
system’s capabilities for the market’s needs and after regulatory approval is
obtained.
Immediately after the commercial launch of the robotic system
for the new applications, Mazor will demonstrate its proprietary navigation
technology to specialists at the hospitals where the company works as the
standard treatment for applications which use electrodes and implants for
deep-brain- stimulation therapy.
Mazor said that both the US Food and Drug
Administration (FDA) and EU CE Mark are reviewing the company’s robotic
navigation surgical system for brain procedures, and that it expects to receive
responses from them during the second half of 2012.
Mazor believes that
the neurosurgery field is an important business opportunity, with 25,000
brain-tissue biopsies are carried out annually in the US alone.
The
market for inserting and navigating implants for deep-brain-stimulation therapy
is currently estimated at hundreds of millions of dollars.
Mazor CEO Ori
Hadomi said, “We are very proud about the first successful robotically-guided
procedures on the brain carried out in the world.
This is the first and
major step for the company and a technological breakthrough.
The first
brain procedures carried out in Germany bring Mazor much closer to the product’s
commercial launch for brain procedures in early 2013.”
Mazor Robotic’s
share price rose 7.3 percent by midday to NIS 3.92, giving a market cap of NIS
86 million.
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