By Mary Vanac

Cleveland Medical Devices spin-off company NeuroWave Systems Inc. is poised to introduce its first commercial product — the NeuroSense Monitor — without taking a single investor dollar.

NeuroSense is a monitor that measures, analyzes and tracks the brain function of sedated or anesthetized patients. So far, NeuroWave and its former parent CleveMed have used federal grants and contracts, and at least one state grant, to develop NeuroSense and other brain monitoring technologies, president and co-founder Tatjana Zikov said.

NeuroWave was spun off in 2008 by CleveMed, a developer of biomedical signal processing and instrumentation devices. NeuroWave moved to its own offices in Cleveland Heights about a year ago. Last week, CleveMed formalized the spin-off by transferring licenses for anesthesia-monitoring and seizure-detection technologies to NeuroWave, which employs 10 full-time workers and six part-time consultants.

“This spin-off is the realization of our 15 years of dedication to research in intelligent and automated brain monitoring,” said Mo Modarres, vice chairman and co-founder of NeuroWave, in a CleveMed press release about the license transfers. “We are now fully self-sustaining and profitable, while our new products will allow for substantial growth.”

The market for brain wave-monitoring devices used during anesthesia is estimated at more than $1 billion a year and growing, according to CleveMed. The market is dominated by Aspect Medical Systems Inc. of Norwood, Mass., according to Neurotech Business Report. Covidien plc acquired Aspect in November 2009 for $210 million.

Aspect uses bispectral index technology to measure and analyze brain waves to gauge the depth of consciousness during anesthesia. NeuroWave uses a technology known as “wavelet-based anesthetic value,” which it claims outperforms bispectral index technology, according to Neurotech Business Report. Chesterfield, Mo.-based engineering firm Everest Biomedical Instruments markets a system that uses yet another technology to assess consciousness, NBR said.

“Brain function monitors are not, as of yet, standard of care,” said Zikov, co-inventor of the NeuroSense technology. “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.”

The NeuroWave system acquires and displays electroencephalogram signals from both sides of the front 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.

In 2003, CleveMed licensed the intellectual property behind NeuroSense from the University of British Columbia and BioNova Technologies Inc., where it was invented and developed, respectively, by Zikov and fellow graduate student Stephane Bibian. Zikov is co-founder of BioNova, which, like the university, is located in British Columbia and was formed to help transfer promising technology to industry from academia, she said.

“NeuroWave is committed to improving patient outcome and quality of life by making brain monitoring cost-effective and accessible through innovative signal processing of brain waves,” Zikov said. “The NeuroSense is the first milestone towards that goal.”

So far, NeuroWave has sustained itself with grants and contracts from the National Institutes of Health and the U.S. Dept. of Defense, Zikov said. She couldn’t put her finger on the amount of grant and contract money NeuroWave has received, because the money came through CleveMed during the company’s formative years.

A search of NIH awards in Ohio revealed NeuroWave received a $1.4 million grant in 2009 and a $1.1 million grant in 2008. The company also benefited from a $174,791 Ohio Third Frontier commercialization grant in 2004.

“Our added value is in bringing the benefits of intelligent signal processing to extract clinical information from biological signals,” Zikov said.

The NeuroSense system is being tested in Europe, where it also is awaiting regulatory market approval. NeuroWave has applied to the Food & Drug Administration for clearance in the U.S. However, it’s likely that European approval will come first, Zikov said.

Meanwhile, NeuroWave is developing NeuroMedic and NeuroFast seizure detection devices for emergency room and pre-hospital patients in both civilian and military settings. NeuroWave is the only company selected by both the NIH and the Defense Dept. to develop seizure detection devices to monitor patients exposed to chemical warfare agents, CleveMed said.

Zikov was not ready to comment on whether her company would become a developer of neuro-monitoring technologies for other companies to commercialize, or one that commercializes those technologies, too. Instead, she said, “We are definitely focusing on efforts to have successful commercialization of our first product, and have a couple of promising technologies in the pipeline.”