News Release

Clinical trial that may help patients breathe easier begins at Central DuPage Hospital

Patient enrollment begins for trial of airway bypass procedure to treat advanced widespread emphysema

Peer-Reviewed Publication

Broncus Technologies

Healthy Lung vs. Diseased Lung

image: Normal vs. hyperinflated emphysema lung view more 

Credit: Broncus Technologies

WINFIELD, Ill., April 1, 2008 — Researchers at Suburban Lung Associates and the Chicago Chest Center recently announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial to explore an investigational treatment for advanced widespread emphysema. The trial focuses on airway bypass, a minimally invasive bronchoscopic procedure designed to help patients with emphysema/COPD (chronic obstructive pulmonary disease) breathe more easily.

Central DuPage Hospital is the only site for the EASE trial in the Chicago area. “Airway bypass could be groundbreaking because it is a potential non-surgical treatment for the patient with diffuse emphysema,” states Dr. Kevin Kovitz, interventional pulmonologist and principal investigator of the study at the Central DuPage Hospital site. “Emphysema, which permanently destroys lung function, is such a devastating disease, and any potential new treatment option could offer substantial relief to the millions who struggle with each breath.”

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 shortness of breath.

Emphysema, a type 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 leave emphysema sufferers unable to get air out of their lungs. As a result, 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.

“If proven, 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 Dr. Kovitz.

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 approximately two hour procedure involves placing up to six drug-eluting stents.

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 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. The EASE trial is designed to see if these results hold in a randomized, controlled trial. That is, a group of patients will receive the stents and others will not. This will allow investigators to see if the stents improve function and quality of life. All participants will help gather information valuable to their fellow emphysema sufferers.

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Involvement in the study will last approximately 15 months to five years and include eight to 16 physician appointments. All study-related medical procedures will be performed at no charge to the patient, with patients closely monitored throughout the trial. Participants will also receive up to 12 weeks of pulmonary rehabilitation therapy.

For more information, please call 1-866-457-EASE (3273).

About Broncus Technologies, Inc.

Broncus Technologies, Inc. is 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.theEASEtrial.com.

About Central DuPage Hospital

Central DuPage Hospital is a nationally recognized 361-bed facility located in Winfield, Illinois, a suburb west of Chicago. It is the third most active hospital in Illinois performing total joint replacements. CDH is a leading center for surgical innovations and was one of the first institutions in the nation to offer robotic-assisted surgery, minimally invasive spine surgery with bio-engineered bone protein as well as the first Level III Neonatal Intensive Care Unit in DuPage County.

Recently, CDH was recognized by U.S. News & World Report on the list of Best Hospitals in the orthopaedics category.

The hospital is part of an interdependent network of health-care organizations and services, including convenient care centers, occupational health services and a full range of options for senior living, home health and hospice care. For more information or to find a doctor, visit www.cdh.org or call (630) 933-4CDH.

Editors Notes

For more information on the EASE Trial at Central DuPage Hospital or to schedule an interview with Dr. Kovitz and a prospective patient, please contact Mindy S. Kolof at 847.317.0408, media@cdh.org

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 more information about the trial, www.EASEtrialUS.com

Dr. Kovitz is not an employee of Central DuPage Hospital and has no personal direct financial affiliation with Broncus Technologies, Inc. The study is sponsored by Broncus Technologies, Inc.


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