CleveMed Blogs

Cleveland, OH - March 23, 2011 - Cleveland Medical Devices Inc. (CMDI) has announced the formation of Great Lakes NeuroTech (www.GLNeuroTech.com), a spin-off company which has acquired the rights to develop, market, and manufacture clinical motor assessment and therapy systems for the movement disorders market as well as physiological monitors for research and education markets. Great Lakes NeuroTech (GLN) will perform R&D, engineering, manufacturing, distribution, and exporting of these technologies through two divisions: Movement Disorders and Research & Education Systems.

“Cleveland Medical Devices Inc. has been growing significantly in the areas of Sleep Disorders, Movement Disorders and Research / Education products. The spin-off will allow CMDI and GLN to further focus their efforts on their core competencies and dramatically boost their commercialization efforts”, said Robert Schmidt, CMDI’s Chairman. “The portability, quality, and cost efficacy of CMDI’s sleep monitoring products and web technologies such as SleepView, eCrytsal PSG, and Sapphire are leading the future of sleep medicine. This spin off will allow CMDI to quickly expand its market presence nationally and worldwide while continuing its excellence in R&D to serve the needs of more than 40 million sleep disorders patients”, said Robert Schmidt.

“The launch of Great Lakes NeuroTech transitions a proven line of innovative medical and research systems, an expert team of engineers and researchers, and high quality manufacturing to a new organization with a focus on these core technologies” said Joseph P. Giuffrida, PhD, GLN’s President. “The transition of technologies, marketing and manufacturing for the movement disorders and research & education product lines from CMDI to GLN is expected to occur in stages over the next few months with no interruption in quality, delivery and support to CMDI or GLN.”

GLN’s Division of Movement Disorders will target Parkinson’s disease and other movement disorders through a portfolio of patient-centered diagnostic and therapy systems integrated with wireless, remote, and web based technologies. Devices to be manufactured by GLN will include KinetiSense™, Kinesia™, and Kinesia HomeView™ systems for capturing movement disorder motor symptoms both in the clinic, at home, and during clinical trials. GLN will continue to grow the product portfolio through ongoing research and development funded by the National Institutes of Health in collaboration with key clinical opinion leaders in the field of movement disorders.

GLN’s Division of Research & Education Systems will market and manufacture a line of wireless physiological monitors and intelligent analysis software targeted to research and education markets. The BioRadio™ is a general purpose physiological monitor for capturing signals such as brain waves, muscle forces and activity, electrical heart activity, respiration, galvanic skin resistance, and pulse oximetry. The BioRadio is packaged in CleveLabs™, a lab course system with sessions for teaching physiology, psychology, health sciences, and biomedical engineering principles; and BioCapture™, a general purpose physiological research system. GLN will continue to expand the growing customer base for these technologies at universities and research institutes both domestically and internationally.

About CMDI

Cleveland Medical Devices Inc.’s mission is to develop, manufacture, and market innovative sleep disorders diagnostic and therapy products that improve the quality of life and reduce total health care costs for patients around the world.

About Great Lakes NeuroTech

Great Lakes NeuroTech is committed to pioneering innovative biomedical technologies to serve research, education, and medical communities, improving access to medical technology for diverse populations, and positively impacting quality of life for people around the world.

Media Contact

Maureen Phillips
Sales & Marketing Manager
216.619.5918
mphillips@GLNeuroTech.com

KinetiSense, Kinesia, Kinesia HomeView, BioRadio, CleveLabs, and BioCapture are trademarks of Cleveland Medical Devices Inc. of Cleveland OH provided under license to Great Lakes NeuroTech.

For the fourth consecutive year, 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.

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.

CleveMed was recognized for the accomplishment at an awards dinner held on May 19th at the InterContinental Hotel in Cleveland.

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

Poor quality of sleep tends to accompany common illnesses, and life stressors (including family and social structure changes); patients tend to visit their primary care physician (PCP) who has knowledge of these factors that are related with their sleep problems. Symptoms and complaints associated with Obstructive Sleep Apnea are often expressed at a higher frequency in the primary care practice setting.

Patients often go to a sleep lab for OSA diagnosis & evaluation. On many instances, the primary care physician looses direct contact with his/her patient’s sleep condition and overall care path. An alternative to sending patients to a sleep lab test is to begin the diagnosis and management process within the primary care setting, by utilizing newer technology that makes sleep diagnosis portable and more readily accessible.

CleveMed’s sleep study network connects the primary care physician to sleep technologists, and board certified sleep physicians, so that the primary doc is able to be involved in the patient’s continuum of care. Here’s how:

This way, the PCP can maintain management of his/her patients’ sleep apnea and associated conditions.