CleveMed Blogs

Cleveland, Ohio – Aug 2, 2010 The Cuyahoga County New Product Development and Entrepreneurship Loan Fund awards Cleveland Medical Devices Inc. $60,000 to step up commercialization of the company’s SleepView device for sleep apnea screening at home.

CleveMed offers a family of wireless diagnostic sleep systems, including SleepView, which is the smallest and lightest home sleep monitor with an American Academy of Sleep Medicine-recommended Type 3 channel set. “This is all about, how do we start to commercialize this more?” said CleveMed chairman Bob Schmidt. “We want to expand from the hundreds of places (where the device is used) now to thousands of places.”

About CleveMed

CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.’s mission is to develop, manufacture and market rehabilitation and monitoring products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.CleveMed.com.

For More Information Contact:

Amy Rickard
Cleveland Medical Devices Inc.
P: 216.791.6720 | F: 216.791.6739
arickard@clevemed.com
www.clevemed.com

Cleveland, Ohio – July 6, 2010 For the fourth consecutive year, Cleveland Medical Devices Inc. (CleveMed) recently received a Leading Edge Award from Entrepreneurs EDGE, which recognizes the Northeast Ohio Mid-Market Companies that create great value for themselves and for their community. CleveMed was also recognized as an Inc 5000 winner.

To qualify for the Leading Edge Award the companies had to have sales revenue up to $750 million and must currently sell some of their goods or services outside the region, or have plans to do so. Factors that were also taken into consideration were: the company’s self-reported EBIT and total taxable compensation for all employees working in Northeast Ohio. EDGE looks at the absolute figure as well as the growth rate of this figure over the past three years.

The Inc. 5000 award recognizes America’s fastest-growing privately held companies. It is a who’s who of the rising stars in business creating a social network of the nation’s top entrepreneurs.

“For middle market companies, receiving the Leading Edge Award for the fourth year in a row and the Inc. 5000 Award for three consecutive years are significant honors” said Robert N. Schmidt, Chairman and CEO of CleveMed. “National and international sales of our FDA cleared and CE marked sleep and movement disorders diagnostics are allowing CleveMed to continue its transition from solely a research company to a medical device manufacturer with an international presence.”

Hani Kayyali, CleveMed’s President stated “These awards validate our growing sales in the sleep apnea home testing market. Our products not only allow patients to sleep in their own beds but they also lower the price of an apnea test from about $2,000 to roughly $250 as well.”

About CleveMed

CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.’s mission is to develop, manufacture and market rehabilitation and monitoring products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.CleveMed.com.

For More Information Contact:

Amy Rickard
Cleveland Medical Devices Inc.
P: 216.791.6720 | F: 216.791.6739
arickard@clevemed.com
www.clevemed.com

CLEVELAND, Ohio (April 12, 2010) - Cleveland Medical Devices Inc. (CleveMed) and NeuroWave Systems Inc. (a spin-off CleveMed in 2008) today announced finalizing their license agreement where CleveMed formally transferred the anesthesia monitoring and seizure detection technologies previously developed by the NeuroWave Division of CleveMed. This includes a number of supporting technologies, including: wavelet analysis of the electroencephalogram (EEG) for anesthetic depth estimation and artifact removal algorithms developed by BioNova Technologies Inc. in partnership with the University of British Columbia, which had previously been licensed to CleveMed. NeuroWave has developed the NeuroSENSE Brain Monitor for Anesthesia, which is currently undergoing testing in Europe and the US and awaiting approvals for sales on both continents; and its upcoming NeuroMedic and NeuroFast products are easy-to-deploy seizure detection devices for emergency room and pre-hospital patients for both civilian and military applications. NeuroWave is also the only company selected by both the National Institutes of Health and the Department of Defense to develop seizure detection devices to monitor patients exposed to chemical warfare agents.

With a market for brain-wave monitoring devices for anesthesiology estimated to exceed a billion dollars, the NeuroSENSE is well positioned for significant sales as an easy-to-use and robust complement to standard-of-care anesthesia monitoring. The system acquires and displays bilateral frontal EEG signals and quantifies brain activity in patients undergoing general anesthesia or sedation. The NeuroSENSE is expected to improve patient safety and outcome by providing instantaneous tracking of the brain state and simultaneous monitoring of both cerebral hemispheres.

CleveMed will continue to focus its efforts on developing medical devices for the sleep disorders and movement disorders markets. The Division of Sleep Disorders has several new products for diagnosis and others in development for therapy of sleep disorders. The systems are uniquely suited not just for studies in the traditional sleep lab, but also for new and emerging applications that benefit from highly portable devices such as home sleep testing, hospital inpatient evaluation, outpatient pre-surgical testing, nursing homes, and “hotel sleep labs”. CleveMed’s Division of Movement Disorders has innovative systems for Parkinson’s disease monitoring research and is close to launching clinically deployable monitors that record movement, restore control and enhance function for disorders such as Parkinson’s disease, stroke and cerebral palsy.

Hani Kayyali, President of CleveMed stated “This is very exciting. The spin-off and licensing transactions will further boost CleveMed’s and NeuroWave’s successes by allowing them to focus their development and commercialization efforts on their respective areas of competencies. This is a great opportunity for CleveMed to realize its full potential as a leading company in sleep disorders and movement disorders”.

Tatjana Zikov, President of NeuroWave 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. The NeuroSENSE is the first milestone towards that goal.” Dr. Mo Modarres, Vice-chairman and Co-founder of NeuroWave, added that “This spin-off is the realization of our 15 years of dedication to research in intelligent and automated brain monitoring. We are now fully self-sustaining and profitable, while our new products will allow for substantial growth.”

Robert N. Schmidt, Chairman of both CleveMed and NeuroWave concluded “The spin-off and license is a testament to the maturity of our products and success of our businesses. We have improved our overall strength and are pursuing additional strategic business development opportunities.”

About CleveMed

CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.’s mission is to develop, manufacture and market monitoring and therapeutic products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.clevemed.com

About NeuroWave

NeuroWave is focused on developing improved clinical brain monitoring devices. The NeuroSENSE monitor is anticipated to be sold in Europe later this year and the NeuroMedic and NeuroFast will follow. For more information, please visit www.neurowavesystems.com

For More Information Contact:

Amy Rickard
Cleveland Medical Devices Inc.
P: 216.791.6720 | F: 216.791.6739
arickard@clevemed.com
www.clevemed.com

Tatjana Zikov
NeuroWave Systems Inc.
P: 216-472-6337 | F: 216-361-1554
tzikov@neurowavesystems.com
www.neurowavesystems.com

CLEVELAND, OHIO, October 27, 2009 – CleveMed recently had its Quality Management System certified to the requirements of ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System by BSI, one of the world′s leading certification bodies. BSI also certified CleveMed to European Medical Device Directive 93/42/EEC which is required to place the CE mark on its products. These certifications allow CleveMed to distribute its products to the large European and the Canadian markets and strengthen its worldwide market presence.

CleveMed designs, manufactures, and sells a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson′s disease. Accuracy, portability and ease-of-use allow CleveMed′s products to be uniquely suited to speed diagnosis and improve disease management of these disorders in emerging US and international markets. These non-traditional, growing markets include the home, hospital rooms, private practices, and many others. As a leader in miniaturized wireless telemetry, physiological monitors CleveMed has been successfully commercializing a research andeducation product line that will benefit tremendously from international markets as well.

“CleveMed undertook the rigorous medical device certification as part of its commitment to developing products with the highest quality that fulfill un-met clinical needs for patients and providers” stated Hani Kayyali, President of CleveMed. “It is a testament to our continued growth and excellence in these important medical fields.”

Robert N. Schmidt, Chairman and CEO of CleveMed stated “This is an important milestone for the company. Opening up new markets for us in Europe and around the world will allow us to double our commercial sales over the next year or two.”

About CleveMed

CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.′s mission is to develop, manufacture and market rehabilitation and monitoring products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.clevemed.com

For More Information Contact:

Amy Rickard
Cleveland Medical Devices Inc.
Phone: 216.791.6720
arickard@clevemed.com
www.clevemed.com