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Researchers begin randomized double-blind trial of airway bypass treatment for emphysema

May 21, 2007

Broncus Technologies, Inc., today announced the start of its EASE (Exhale Airway Stents for Emphysema) Trial to explore an investigational procedure that may offer a new, minimally-invasive treatment option for millions of emphysema sufferers. The study focuses on a procedure called airway bypass that uses drug-eluting stents to reinforce new pathways in the lung for trapped air to escape. This in turn, may relieve severe emphysema symptoms such as shortness of breath.

Leading pulmonologists and thoracic surgeons at medical centers around the world are participating in the EASE Trial to study the safety and effectiveness of airway bypass in people struggling with severe homogenous (or diffuse) emphysema. During the trial, patients are randomized two-to-one to the treatment group (receiving bronchoscopy with placement of the drug-eluting stents) or the control group (undergoing only a bronchoscopy procedure). The trial is underway at 15 leading research institutions with more than 20 patients already randomized. At least 225 patients will be enrolled at up to 45 institutions during the next 12 to 18 months.

Emphysema 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 the emphysema sufferer with hyperinflation because they can't get air out of their lungs. Breathing becomes inefficient and patients are always short of breath - making even nominal physical activities difficult. The airway bypass procedure creates new pathways in the lung with the intention of reducing the amount of air trapped in the lungs, thereby helping patients breathe easier.

Emphysema afflicts tens of millions of people worldwide with more than 3 million sufferers in the United States. There is no cure for emphysema.

"The EASE Trial is important because airway bypass may help patients with widespread emphysema whose disease has destroyed tissue throughout the lung. For this patient population, the only current surgical option is lung transplantation," states Joel Cooper, M.D., a pioneer in thoracic surgery, developer of the airway bypass procedure and Chief of the Division of Thoracic Surgery at the University of Pennsylvania Health System. Dr. Cooper is also a co-principal investigator of the EASE Trial and a consultant to Broncus. "By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation, improve lung function, and restore the mechanics of breathing."

For patients in the treatment group receiving airway bypass, the physician advances a flexible bronchoscope through the mouth into the airways. There the physician creates new small pathways and places an Exhale® Drug-Eluting Stent - manufactured by Broncus Technologies, Inc. - to allow the trapped air in the lung to escape. The study will determine if patients experience an improvement in dyspnea (shortness of breath) and lung function. The procedure, like many other bronchoscopic procedures, is done under deep sedation or general anesthesia, and the patient returns home the next day.

"With feasibility studies outside of the US already completed, we are very pleased to commence this important pivotal clinical study in collaboration with many of the world's foremost emphysema experts," says Cary Cole, CEO of Broncus.

Ten institutions in the US and five others around the world are 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.

Broncus Technologies