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Broncus Reports Early EASE Trial Results for Airway Bypass With Exhale(R) Drug-Eluting Stents

Posted Nov 18 2009 10:02pm

Broncus Technologies, Inc., a medical
technology company focused on developing
and commercializing innovative solutions for
lung diseases, is announcing early results of the
EASE (Exhale Airway Stents for Emphysema) Trial,
the first ever, double-blinded randomized,
sham-controlled device study for patients
with emphysema/COPD. The EASE Trial,
which was designed to evaluate the safety
and effectiveness of the Airway Bypass procedure with Exhale Drug-Eluting Stents,
did not meet the 6 month co-primary endpoints of improving forced vital capacity (FVC) and modified Medical Research Council (mMRC) dyspnea score when compared to controls, though mMRC alone did show statistically significant improvement.

Trial results demonstrated strong proof of Airway Bypass’ mechanism of
action. Analysis of those subjects who met the co-primary endpoints showed
that a residual volume (RV) reduction greater than 500mL is a key predictor
for success. RV reductions greater than 500mL post-treatment and at 1
month, correlated with statistically-significant improvements in multiple
pulmonary function and emphysema symptom endpoints. More than 40% of
treated subjects achieved this degree of RV reduction post treatment.
Treatment effects were not significant if the initial RV reduction was less
than 500mL. The Company is actively analyzing the EASE Trial database and
CT data to optimize procedural success.

“While we are disappointed that we did not win both of the co-primary
endpoints of this trial, we are pleased to see the significant long term
improvement in mMRC and the RV subset data, both of which corroborate the
mechanism of action of Airway Bypass. We expect this rich and growing data
set, along with our LungPoint(TM) Virtual Bronchoscopic Navigation system,
will help us further improve the Airway Bypass treatment algorithm,” said
Cary Cole, President and CEO of Broncus Technologies.

Airway Bypass is a minimally-invasive bronchoscopic procedure designed to
reduce lung hyperinflation (RV) and shortness of breath, the clinical
hallmarks of emphysema/COPD. During the procedure, new openings are created
in the airway walls, which then connect the damaged lung tissue to the
natural airway. By bypassing the collapsed airways, air that was trapped
has a way to exit the lungs. The Exhale Drug-Eluting Stent is designed to
support these extra-anatomic pathways.

Participants in the EASE Trial were randomized two-to-one into treatment
and control groups. While subjects in the treatment group received the
Airway Bypass procedure, the control group underwent bronchoscopy but did
not receive the stents. The prospectively-defined clinical endpoints were
Forced Vital Capacity (the amount of air that can be exhaled in a single
breath) and the modified Medical Research Council score, a measure of the
impact of breathlessness on quality of life. Six months after treatment,
participants who had clinically significant improvements in both these
measurements were considered a responder. The responder rates for the
treatment and control groups were then analyzed for statistically
significant difference. 315 patients were enrolled at more than 40 leading
lung centers worldwide. Post hoc analysis is ongoing to determine stent
placement patterns associated with improved pulmonary and functional
outcomes.

more…

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