SOURCE: Broncus

October 09, 2007 08:38 ET

Encouraging Results Reported on Airway Bypass Procedure

Airway Bypass Study Featured in Journal of Thoracic and Cardiovascular Surgery

MOUNTAIN VIEW, CA--(Marketwire - October 9, 2007) - Broncus Technologies, Inc., a medical device company investigating the airway bypass procedure for the treatment of emphysema, today announced that the results of its open-label Exhale® Drug-Eluting Stent feasibility study have been published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results include 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.

Airway bypass is a catheter-based bronchoscopic procedure designed to reduce lung hyperinflation and improve breathlessness (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. The hope is to improve quality of life by relieving severe symptoms including shortness of breath and hyperinflation of the chest.

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. Treatment options for most patients with emphysema are currently limited and generally result in anguished patients and frustrated physicians.

The prospectively defined primary endpoint of this feasibility study was a reduction in residual volume (RV, the amount of air remaining in the lungs after full exhalation) at 6 months. The goal was for a 300mL reduction in RV. Overall the trial surpassed that goal with a 400mL improvement in RV over baseline at 6 months (p=0.04). Patients also showed a statistically significant improvement in the modified Medical Research Council Dyspnea Scale (mMRC), a breathlessness test, of -0.5 points (p= 0.025). Retrospective analysis revealed that patients with the most severe hyperinflation of their lungs (as determined by a residual volume to total lung capacity ratio above the median) derived the greatest benefit from airway bypass. At 6 months after the procedure, these patients showed a mean improvement in RV of 870mL (p=0.022).

"The management of emphysema poses a difficult challenge for the medical community as the disease progressively deprives patients of their ability to perform daily activities. These findings are encouraging because there are so few options for the millions patients who suffer from this disease," states Paulo F.G. Cardoso, M.D., Ph.D, Division of Thoracic Surgery, Santa Casa de Porto Alegre-Pavilhao Pereira Filho Hospital, Brazil and lead author of the paper. "These results reveal significant improvements in pulmonary function and reduction in breathing difficulties out to six months and indicate that airway bypass is a potentially viable therapeutic option for patients with marked severe pulmonary destruction, whose only current option may be to wait for a lung transplant."

"The data from this study are very exciting, as they help build the case that airway bypass might reduce hyperinflation and have long term benefit," states Cary Cole, CEO of Broncus. "We hope to continue this success with the current, pivotal EASE Trial, our largest clinical study to date."

The EASE Trial

Airway bypass is currently being investigated in the pivotal IDE Exhale Airway Stents for Emphysema (EASE) Trial. Over 50 patients have been randomized in the trial, underway at over 20 leading research institutions around the world.

Leading pulmonologists and thoracic surgeons are studying the safety and effectiveness of airway bypass in people struggling with severe homogenous (or diffuse) emphysema in a prospective, randomized, sham-controlled, double-blind study. At least 225 patients will be enrolled at approximately 45 sites in North America, Europe, Australia and South America during the next 12 to 18 months. 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 smokes (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.

Researchers are careful to point out that there is no expectation that this new investigational procedure will cure emphysema. However, it is hoped that the procedure will prove useful in reducing the severity of symptoms, by improving pulmonary function and the quality of life for patients with the disease.

About Broncus Technologies, Inc.

Broncus Technologies, Inc. is helping people breathe easier by developing bronchoscopic interventions for lung diseases. Founded in 1997, Broncus Technologies has developed the Exhale® Drug-Eluting Stent for use in the patented airway bypass procedure, a minimally-invasive, bronchoscopic procedure being investigated 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 homogeneous 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.