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Amy Rickard
Cleveland Medical Devices Inc.
Phone: 216.791.6720
arickard@clevemed.com
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FOR IMMEDIATE RELEASE


CLEVEMED IS AWARDED $1.25 MILLION IN NIH FUNDING FOR MONITORING DIABETIC FOOT ULCERS


CLEVELAND, OHIO, November 2, 2005 - CleveMed announced that it has been awarded $1.25 million in NIH Phase II funding. The proceeds from the grant will fund the continuation and expansion of CleveMed's Clinical Step Monitoring program.

Patients with diabetes mellitus and peripheral neuropathy are at a high risk for foot ulcers, and subsequently, associated amputations. An estimated 16 million Americans have diabetes mellitus, and about 15% of them will develop foot ulcers. Foot ulcers that become infected can lead to amputation, making diabetes the leading cause of non-traumatic lower extremity amputations. The American Diabetes Association estimates that approximately 85% of these amputations could be prevented. Although repetitive pressure is known to be a key factor, specific risk levels are still unknown due to the lack of any existing devices that can unobtrusively measure the repetition of pressures and weight-bearing duration over extended periods of time.

The goal of the Clinical Step Monitoring program is to provide an innovative, yet practical and inexpensive product to monitor the amount of pressure at high risk locations over long periods of time. This product will allow researchers to better estimate the relationship between changes in activity levels and the likelihood of ulcer formation and then aid in the treatment of patients with diabetes, peripheral neuropathy and a history of ulcer.

"I was extremely impressed with the Phase I device and look forward to working with CleveMed during the development and testing of the Phase II device. I see this work having great potential in both clinical evaluation and as a research tool," said Dr. Peter R. Cavanagh, Chairman of the Cleveland Clinic Foundation's Department of Biomedical Engineering.

According to Dr. Matthew Tarler, CleveMed Principal Investigator, "this project will provide a new clinical tool that has the potential of advancing the field of ulcer prevention. This project is just one of many in CleveMed's Ulcer Management Division that are being developed to assist in ulcer prevention and improve overall healthcare."

About CleveMed

CleveMed was founded with the goal of developing, manufacturing, and marketing biomedical signal processing and instrumentation devices. CleveMed has since become a leader in miniaturized telemetry, physiological monitoring, and rehabilitation devices. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research, and academic communities.
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