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Researchers at Pulmonary Associates to study airway bypass procedure for severe emphysema

Pulmonary Associates is the first center in Arizona to begin the EASE Clinical Trial

Broncus Technologies

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IMAGE: Airway Bypass is a catheter-based bronchoscopic procedure to treat emphysema/COPD. view more

Credit: Broncus Technologies

Phoenix, AZ, February 11, 2008 - Researchers at Pulmonary Associates today announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a new, minimally invasive option for those suffering with advanced widespread emphysema. The trial focuses on airway bypass, a catheter-based 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 minimally invasive 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. The trial procedures will take place at the John C. Lincoln North Mountain Hospital.

"We are excited to be part of this study because currently there are limited treatment options for patients with severe emphysema. Patients struggle with each breath," states Bernard Levine, MD, Principal Investigator of the study at Pulmonary Associates. "If we can reduce hyperinflation and improve lung function with airway bypass, patients will be able to breathe easier leading to a better quality of life."

Emphysema, also known as COPD, is a characterized by a chronic, progressive, and irreversible destruction of lung tissue. The lungs lose their natural elasticity and are unable to exhale effectively, leading to air trapping within the lungs and lung overinflation. 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 severe 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 Bernard Levine, MD, Principal Investigator. "Currently our center is the only place in the state of Arizona for patients to participate in the EASE Trial and potentially undergo this procedure."

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 one to two hours.

This procedure is still under clinical investigation, but early data suggest it may hold promise for patients with emphysema.

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Pulmonary Associates is currently recruiting patients for the EASE Trial. The study will be a randomized controlled trial meaning that patients will be randomly assigned to either a treatment or a smaller control group. Both groups will undergo bronchoscopy but only the treatment group will receive the airway bypass procedure. All subjects will have comprehensive medical evaluation and laboratory studies and will receive at least 14 weeks of pulmonary rehabilitation therapy. Involvement in the study will last from approximately 15 months up to 5 years (depends on whether 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.

For more information please call 866-431-3273 or visit www.EASEtrialUS.com.

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, a minimally-invasive procedure to treat emphysema. Airway bypass creates new pathways in the lung for air to escape and 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. For more information visit www.broncus.com.

About the John C. Lincoln North Mountain Hospital

John C. Lincoln Hospital North Mountain was named one of the best hospitals in the country for respiratory care by U.S. News and World Report.

Editors Notes

For more information on the EASE Trial at Pulmonary Associates or to schedule an interview with Dr. Bernard Levine, please contact Pulmonary Associates at 602-258 4951.

For general information on the EASE Trial, airway bypass, or Broncus Technologies, please contact Meghan Oreste at 617-823-1441 or moreste@comcast.net

For questions about enrolling in the trial call 866-431-3273 or visit www.EASEtrialUS.com

Bernard Levine, MD has no personal direct financial affiliation with Broncus Technologies, Inc. The study is sponsored by Broncus Technologies, Inc.

Broncus and Exhale are trademarks of Broncus Technologies, Inc.

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