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Amy Rickard
Cleveland Medical Devices Inc.
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FOR IMMEDIATE RELEASE


CleveMed to Collaborate with Robert Thomas MD on New Sleep Apnea Therapy


CLEVELAND, OHIO, OCTOBER 20, 2008 - Today, CleveMed announced that it had entered into an exclusive agreement with Robert Thomas MD of Beth Israel Deaconess Medical Center (BIDMC, a Harvard Medical School affiliate) to develop and commercialize a new therapeutic technology for sleep apnea. Technology completion and clinical validation on more than 100 patients will be supported by a recent NIH SBIR Fast Track grant awarded to CleveMed with BIDMC and Wayne State University as the two clinical sites.

Sleep apnea is a serious chronic disorder affecting more than 15 million Americans. Patients with sleep apnea stop breathing numerous times during the night, which fragments their sleep and stresses the cardiopulmonary system during what is supposed to be a restful and regenerative period. The result is marked daytime sleepiness and worsening of many heart and lung diseases that often coexist with sleep apnea.

Sleep apnea has many forms, like Obstructive (OSA), Central (CSA), and Complex (CompSA). OSA is the only form with an effective treatment - forcing air into the patient’s upper airways via a mask to keep the pharynx open (Continuous Positive Airway Pressure – CPAP). However, CSA and CompSA, which are strongly linked to serious heart and lung diseases remain largely untreated. It is suspected that more than 25 % of Congestive Heart Failure (CHF) patients have CSA or CompSA. Furthermore, Central or Complex apnea events often coexist with OSA, which can compromise the effectiveness of the popular CPAP therapy.

The technology, which was created by Dr. Robert Thomas at BIDMC, Boston and Mr. Robert W. Daly of Wellesley, Massachusetts, is based on injecting small amounts of CO2 levels into the patient while applying CPAP. A major contributor to CSA and CompSA is thought to be an increased sensitivity to CO2 levels, which causes central apneas readily when the patients fall asleep. This is especially true during CPAP since the increase in breathing lowers CO2 in those patients; thus, triggering central apnea. "By introducing 0.5% to 1% of CO2 during CPAP, we have found that the patient′s normal breathing is restored", said Dr. Thomas. "The key is to prevent a drop in CO2; there is no need to increase CO2 above wake levels. The implications are huge. Not only will such technology bring relief of symptoms to CSA and CompSA patients, but may also improve cardiac function itself as the restoration of normal breathing may relieve stresses on the heart. The project with CleveMed will test the benefit on patients with and without CHF and both CSA and CompSA."

"We are very excited about this partnership", said Hani Kayyali, CleveMed president. "Dr Thomas’s innovative technology combined with CleveMed′s product development and commercialization expertise in the sleep industry will bring a new product to a very important but underserved patient population. This collaboration strengthens our strategy of pioneering new diagnostic and therapeutic technologies for sleep disorders especially for patients with sleep disordered breathing."

About CleveMed

CleveMed was founded with the goal of developing innovative telemetry devices for a variety of medical applications. Today, CleveMed is developing and pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications, including movement disorders, sleep disorders and brain monitoring. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities. For more information, please visit www.CleveMed.com
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