CleveMed Blogs

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

To see how Mic Iver RPSGT serves the underserved… www.clevemed.com/adventureRPSGT

On a less playful note: The Sapphire PSG complete sleep study platform is small and wireless, and fits in a portable brief-case of sorts. Because it operates wirelessly, it saves a lot of time and lab set-up costs, and the hotel/sleep lab facility won’t have to be expensively hard-wired with cables. Sapphire PSG uses state-of-the-art, wireless hardware with two frequency options (902-928 MHZ or 2.4-2.485 GHz.) built into the system; you can choose the model that best suits your environment. (It’s also more convenient for the patient who need not be tethered to the acquisition system).

"You get what you pay for" – an idiom that has been around just about forever. It suggests that the quality of a product improves or increases with the amount of money one pays for that product. But for medical devices, quality products need to equate to more than a just a price tag.

Quality medical devices need to equate to a commitment – a commitment from top executive management that the products a company produces, not only meet “customer” requirements, but are safe and effective for their intended use. This commitment is to be communicated to all individuals at all levels of the organization who need to "buy–in" to it - and since this commitment is driven from the top down, employee resistance or "push back" should be reduced into the "slim to none" category!

Because they know their job functions best, employees need to become actively involved in the development of processes and procedures specific to their area of responsibility. These processes and procedures will evolve into the company’s "bible" or Quality System that guides and directs the operation.

"Customers" can be "internal" (engineering may be a customer of marketing, manufacturing may be a customer of sales) as well as external (regulatory agencies are customers of the Quality & Regulatory department, the end user or patient is a customer of sales or product support). A quality medical device is produced when customer requirements and specifications are translated into attainable and realistic design inputs. These inputs will develop into a finished medical device which, prior to being released to market, must go through extensive verification/validation testing to ensure the medical device functions according to specifications and is indeed safe and effective.

Consistency is paramount. Adhering to those employee developed processes and procedures such as purchasing items used in manufacturing only from pre-determined, experienced and competent suppliers are instrumental in maintaining the quality of a medical device.

Lastly, the commitment to quality cannot ever become stagnant. Customer requirements, customer feedback, processes and procedures used in product design and manufacturing as well as the infrastructure of the business itself must be continuously monitored, assessed, measured and improved upon if the medical device organization is to remain competitive, profitable and compliant with regulatory agencies.

Notice that throughout this blog cost was never mentioned? Sometimes you get a lot more than what you pay for!