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NeuroWave earns CE Mark in the EU

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By Mary Vanac

Medical device start-up NeuroWave Systems Inc. received CE Mark approval in the European Union for its first product, the NeuroSense anesthesia monitor.

The Cleveland Heights-based company has been developing its brain-monitoring device since 2003, when it licensed the technology from co-inventor and now NeuroWave president, Tatjana Zikov.

“This is a big day for the NeuroWave Systems’ team as we have been working toward this goal for eight years,” Zikov said in a press release. “We are committed to developing innovative brain monitoring technologies for improved cerebral protection and patient outcomes.”

Spun off by Cleveland Medical Devices in 2008, NeuroWave has its own office, licensing agreement and 10 full-time employees to begin marketing NeuroSense — a monitor that measures, analyzes and tracks the brain function of sedated or anesthetized patients.

So far, NeuroWave has used federal grants and contracts and at least one Ohio grant to develop NeuroSense and other brain monitoring technologies — and not a single dollar from investors. The company is pursuing Food & Drug Administration approval to sell its device in the U.S.

The NeuroWave system acquires and displays electroencephalogram signals from both sides of the front part of the brain. Monitoring both sides of the brain is important for detecting anesthesia-related pathologies, such as stroke, that can affect only one part of the brain.

The system quantifies brain activity in patients undergoing general anesthesia or sedation. It also qualifies this information by providing real-time feedback on both cerebral hemispheres. In this way, NeuroSense could improve patient safety and outcomes during anesthesia.

Brain function monitors are not yet the standard of care, Zikov said.

“The benefits of these monitors have been widely publicized. We would be on a good path if these, indeed, become standard of care in years to come,” she said.

The market for brain wave-monitoring devices used during anesthesia is estimated at more than $1 billion a year and growing, according to Cleveland Medical Devices. The market is dominated by Aspect Medical Systems Inc. of Norwood, Mass., according to Neurotech Business Report. Covidien plc (NYSE:COV) acquired Aspect Medical in November 2009, paying $210 million or $12 per share.

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