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Franklin Square to study airway bypass procedure for severe emphysema

October 27, 2008

October 27, 2008 (Baltimore, MD)--Franklin Square Hospital Center announces the start of the EASE (Exhale Airway Stents for Emphysema) Trial to explore an investigational treatment for advanced widespread emphysema/COPD. The trial focuses on airway bypass, a bronchoscopic procedure designed to reduce lung hyperinflation and shortness of breath (the clinical hallmarks of emphysema/COPD) by making new pathways for trapped air to exit the lungs.

During the airway bypass procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. These pathways are supported and kept open by Exhale® Drug-Eluting Stents - manufactured by Broncus Technologies, Inc. Patients could see an immediate improvement in dyspnea (shortness of breath).

"We are excited to be part of this study because currently there are limited treatment options for emphysema. Patients are often in poor physical condition, struggling with each breath," states William Krimsky, MD, director of Interventional Pulmonology at Franklin Square and principal investigator of the study. "By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and improve lung function. If patients can breathe easier it is likely to improve their quality of life."

Emphysema, a component of COPD, is a chronic, progressive, and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lungs' natural elasticity and the collapse of airways in the lung combine to make exhalation ineffective, leaving emphysema sufferers with hyperinflation because they are unable to get air out of their lungs. Breathing becomes inefficient and patients have to work very hard just to breathe - making normal activities, like walking, eating or even bathing, difficult. There are few treatment options for most patients with emphysema and there is no cure.

"The airway bypass procedure could be an excellent option for those who are not suitable candidates for lung transplant surgery or who would possibly spend years on a lung transplant list," states Krimsky. "Given that emphysema, which permanently destroys lung function, is such a devastating disease -- any potential new treatment option could offer substantial relief to the millions who suffer."

Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is away from blood vessels. A special needle is then used to make a small opening and an Exhale Drug-Eluting Stent is placed in the passageway to keep it open. The procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately two hours.

Although this procedure is still under clinical investigation, feasibility data suggest it may hold promise for patients with emphysema. Results from the open-label Exhale Drug-Eluting Stent feasibility study were published in the October 2007 issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results included a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure.
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Franklin Square Hospital Center is currently recruiting patients for the EASE Trial. Involvement in the study will last from approximately 15 months up to 5 years (depending on if the patient is randomized to the control or the treatment group) and include 8 to 16 physician appointments. All study-related medical procedures will be carried out at no charge to the patient and patients will be closely monitored throughout the trial. Participants will also receive at least 14 weeks of pulmonary rehabilitation therapy. If you or someone you know over the age of 35 have been diagnosed with advanced widespread emphysema and no longer smoke (or would be willing to stop smoking two months prior to the study), you may qualify to participate in this study. For more information please call 410-494-7978.

About Franklin Square Hospital Center

Franklin Square Hospital Center is the third largest hospital in central Maryland, providing a comprehensive array of primary care and specialty services. Its core services include oncology, emergency medicine, cardiology, surgery, obstetrics/gynecology, orthopedics and family medicine. Franklin Square also offers programs in psychiatry and pediatrics. Its residency programs focus on three concentrations: internal medicine, family practice and ob/gyn. Visit www.franklinsquare.org for more information.

About MedStar Health

MedStar Health is a $2.9 billion non-profit healthcare organization and a community-based network of seven hospitals and other healthcare services in the Baltimore/Washington region. The hospitals, which include both teaching and community facilities, are Franklin Square Hospital Center, Good Samaritan Hospital, Harbor Hospital, and Union Memorial Hospital in Baltimore, Maryland, and Georgetown University Hospital, National Rehabilitation Hospital, and Washington Hospital Center in the District of Columbia. MedStar Health is based in Columbia, Maryland and as the area's largest health system, it is one of its largest employers, with more than 23,000 employees and 4,600 affiliated physicians, all of whom support MedStar Health's patient-first philosophy that combines care, compassion and clinical excellence with an emphasis on customer service. We prove this everyday with over 145,000 inpatient admissions and more than one million outpatient visits each year.

About Broncus Technologies, Inc.

Broncus Technologies, Inc. is helping people breathe easier by developing bronchoscopic interventions for the treatment of chronic lung diseases. Founded in 1997, Broncus Technologies has developed the Exhale® Drug-Eluting Stent for use in the airway bypass procedure. During airway bypass new passageways are created in the lung for air to escape which may potentially improve the breathing abilities of patients with emphysema. Broncus Technologies is currently conducting the pivotal EASE Trial to evaluate the safety and efficacy of airway bypass in the treatment of advanced widespread emphysema.

Broncus Technologies

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