Angiotech Pharmaceuticals, Inc. today announced positive clinical study results for its Bio-Seal™ Lung Biopsy Tract Plug System at the Society of Interventional Radiologists Annual Scientific Meeting in San Diego, CA. The trial assessed the safety and efficacy of Bio-Seal in patients undergoing lung biopsy procedures and demonstrated a statistically significant clinical benefit in the group receiving BioSeal.
“We are extremely pleased that the Bio-Seal treatment arm hit the primary end point of clinical success,” said Dr. William Hunter, President and CEO of Angiotech. “These results indicate that Bio-Seal improves the existing technology used to diagnose lung cancer by significantly reducing the rates of pneumothorax.”
The purpose of this clinical study was to assess the safety and efficacy of an expanding hydrogel plug in reducing pneumothorax rates associated with CT-guided lung biopsy. The prospective, randomized, controlled clinical study enrolled and randomized 339 investigational patients at 15 different investigational sites. Inspiratory upright chest x-rays were performed at 30 to 60 minutes, 24 hours and 30 days after treatment. The Bio-Seal treatment arm hit the primary end point of clinical success, absence of pneumothorax at each time period. Based on the per-protocol population, clinical success rate was 85% using Bio-Seal and 69% in the control group. This difference was statistically significant (p=0.002).
Although not powered for statistical analysis, positive trends were also observed for Bio-Seal subjects as compared to the control group in various secondary endpoints, including fewer Bio-Seal subjects admitted to the hospital for pneumothoraces (9.4% vs. 13.6%), fewer chest tube placements in Bio-Seal patients (3.5% vs. 10.7%), and fewer additional chest x-rays required in Bio-Seal patients (0.6% vs. 5.3%). Angiotech is the worldwide manufacturer and distributor of the Bio-Seal Lung Biopsy Tract Plug System, which has already received CE Mark approval and is currently marketed and sold in the EU.