Angiotech announces positive results from Bio-Seal(TM) clinical study
“We are extremely pleased that the Bio-Seal treatment arm hit the primary end point of clinical success,” said Dr.
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 tubes 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.
About BioSeal(TM) Lung Biopsy Tract Plug System
Bio-Seal is a novel technology designed to reduce the incidence of post-operative pneumothorax (collapsed lung) in patients who undergo lung biopsy procedures. The technology involves the placement of an expanding hydrogel plug along the biopsy needle track during the procedure, closing off the track to subsequent influx of air into the chest during respiration after the biopsy needle is withdrawn. The seal is airtight and the plug is absorbed into the body after healing of the puncture site has occurred.
Forward Looking Statements --------------------------
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(C)2009 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
Bio-Seal(TM) is a trademark of Medical Device Technologies, Inc., a wholly-owned subsidiary of Angiotech Pharmaceuticals, Inc.
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
SOURCE Angiotech Pharmaceuticals, Inc.