CleveMed Blogs

Happy New Year doodle from CleveMed

CleveMed extends its warmest wishes for a happy, healthy and prosperous new year to our valued customers, employees and clinical collaborators.

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

CleveMed has announced the promotion of Joseph P. Giuffrida, PhD to Vice President, General Manager of the Division of Movement Disorders. CleveMed is continually expanding as a medical device company and Dr. Giuffrida will continue to fill a crucial role to assist with the company’s success.

Dr. Giuffrida, 33, completed his BS, MS and PhD in Biomedical Engineering at Case Western Reserve University with a concentration in rehabilitation engineering. He began his career at CleveMed in 2000 as an Applications Engineer and upon receipt of his PhD in 2004, became a Principal Investigator and eventually Director of the Division of Movement Disorders. Within these roles, Dr. Giuffrida has secured over $10 million in funding from both the National Institutes of Health and the State of Ohio to fuel the research, development, and commercialization of innovative medical devices focused on aiding in the diagnosis and therapy of movement disorders. He has secured FDA clearance to market for a number of CleveMed systems, managed reimbursement strategies for new and emerging technology, established multiple world renowned key opinion leaders and clinical consultants, and lead the marketing and sales teams for CleveMed’s clinical movement disorder products as well as the research and education product lines.

Most notably, CleveMed’s Division of Movement Disorders commercialized and launched Kinesia under Dr. Giuffrida’s direction. This technology is intended to provide a standardized platform for objectively quantifying motor symptoms associated with Parkinson’s disease. Additional research and development in this Division is focused on extending the market applications for Kinesia from clinical office visits to home monitoring and deep brain stimulation programming, assistive technologies to aid in communication for persons with limited mobility and speech impairment and the development of rehabilitation systems to aid in motor recovery after brain injuries such as stroke or cerebral palsy.

In addition to the Division of Movement Disorders, Dr. Giuffrida also manages CleveMed’s line of products focused on the research and education market. Dr. Giuffrida was able to commercialize CleveMed’s wireless physiological monitoring technology into specific academic and university based target applications to increase CleveMed’s sales both domestically and internationally.

Have you ever thought about something you could do to help out in your community? Or things you could be involved with that may help improve the lives of others? CleveMed is involved with a number of non profit organizations and community groups that support Parkinson’s disease research, patients and their families. Because of the research that CleveMed does involving Parkinson’s, it’s important to make sure that these types of organizations are aware of new findings, outcomes, and breakthroughs so that the information can be shared with patients. These types of organizations are also a great resource because they can spread the word about clinical trials being conducted and helping patients become involved.

Below are links to organizations in Ohio and the Northeast area:
Courageous Steps for Parkinson’s:
http://www.courageoussteps.com/
Ohio Parkinson Foundation Northeast Region:
http://ohparkinson.org/
Tri State Parkinson’s Wellness Center:
http://www.parkinsonswellness.org/
Central Ohio Parkinson Society:
http://www.centralohioparkinson.org/

Here are some organizations on the national level that can always use support and help:
The Tremor Action Network:
http://www.tremoraction.org/
National Parkinson Foundation:
http://www.parkinson.org
American Parkinson’s Disease Association:
http://www.apdaparkinson.org
The International Essential Tremor Foundation:
http://www.essentialtremor.org/

The above organizations provide invaluable resources for Parkinson’s disease research and patients and provide a place where people affected can go to for support and information. Please visit these websites to find out more information on how you can become involved or donate.