SOURCE: Broncus Technologies

May 19, 2008 08:45 ET

Over 135 Patients Randomized in Airway Bypass Trial for Emphysema

EASE Trial Underway at Almost 40 Leading Research Hospitals on Four Continents -- Trial Looks at New Investigational Minimally-Invasive Procedure for Emphysema

MOUNTAIN VIEW, CA--(Marketwire - May 19, 2008) - Broncus Technologies, Inc., a medical device company that is investigating a stent-based procedure for the treatment of emphysema, announced today at the Annual Scientific Assembly of the American Thoracic Society (ATS), that over one hundred and thirty-five patients have been randomized in the EASE Trial for airway bypass. The EASE (Exhale Airway Stents for Emphysema) is a randomized, double-blind clinical trial to study the safety and effectiveness of the airway bypass procedure. This study is designed to include up to 450 patients around the world.

Airway bypass is initially being studied exclusively in patients with homogeneous emphysema (estimated at approximately 65% of all people with emphysema) whose only treatment options today are medical management and lung transplantation, both of which have significant limitations. Airway bypass is designed to reduce lung hyperinflation and shortness of breath (the clinical hallmarks of emphysema/COPD) by creating 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 passageways are supported and kept open by Exhale® Drug-Eluting Stents. The hope is to improve airflow and in turn relieve severe symptoms such as shortness of breath.

"This is important research because airway bypass could prove to help patients with widespread emphysema whose disease has destroyed tissue throughout the entire lung," explains Pallav Shah, MD, Principal Investigator of the study at the Royal Brompton Hospital in London, England and the leading recruiter in the study to date. "It is an exciting time in bronchoscopy with the development of these minimally invasive techniques. The great advantage of this technique is that patients have a negligible intensive care unit stay and a much shorter stay in hospital compared to standard surgical treatments."

Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians first use Broncus' 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 investigational procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately two hours.

"Emphysema permanently degrades lung function and can be a devastating disease to live with. There is no cure for emphysema so any potential new treatment option could offer substantial relief to emphysema sufferers," states Roger Maxfield, MD, Principal Investigator of the study at NewYork-Presbyterian Hospital/Columbia University Medical Center. "By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and thereby improve lung function. If patients can breathe more easily it is likely to improve their quality of life."

While this procedure is still under clinical investigation, early 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.

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.

About 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 866-431-3273 or visit www.EASEtrialUS.com.

About Broncus Technologies, Inc.

Broncus Technologies, Inc. is medical technology company focused on developing and commercializing minimally-invasive medical devices for emphysema and other 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 severe widespread emphysema. For more information visit www.broncus.com.

Editors Notes

For more information on the EASE Trial 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

Broncus and Exhale are trademarks of Broncus Technologies, Inc.