January 9, 2007
Cleveland Medical Devices Inc (CleveMed) announced that it has been awarded $2.3 M in NIH SBIR Phase II Continuation funding from the National Institute of Neurological Disorders and Stroke (NINDS). The grant will fund clinical inpatient evaluation of sleep disordered breathing (SDB) in cardiac patients preoperatively. In addition to completing development of a compact, telemetry-based PSG system better suited for sleep evaluation in that specific application, the grant will fund a large clinical trial that will be conducted at the Cleveland Clinic Foundation with Dr Nancy Foldvary-Schaefer and Dr Roop Kaw and at Johns Hopkins University with Dr Nancy Collop. Clinical superiority over currently used screening tools and SDB prevalence and morbidity rates in the cardiovascular surgery population will be determined.
“There is an urgent need to improve the diagnosis of sleep disordered breathing in surgical patients in order to avoid complications intraoperatively and postoperatively,” Dr Collop said.
Cleveland Medical designed its Crystal Monitor® PSG line of products to make it easier for physicians to diagnose sleep disorders by making it possible to perform sleep studies not just in the traditional sleep labs, but also in a variety of non-traditional settings. “We want to pioneer the use of sleep evaluation on the ward through the use of new technology that is beneficial to patients, trusted by physicians and cost effective to hospital administrators”, said Hani Kayyali CleveMed president and grant principal investigator.
