SBIR and STTR Success Story for
Biopsy Sciences

(Information Posted/Updated on 11/24/2008)

Biopsy Sciences
4900 Creekside Dr.
Clearwater, FL  33760

Contact:    John Fisher, MD
Phone:      727-510-2777
Fax:          727-290-9828
Web Site:

Project Title:  Biodegradable Sealant for Biopsy Tract in Soft Tissue
Related Award(s):  R44 CA097627
Technology Developed:
The BioSEAL consists of a delivery system and a dessicated hydrogel plug that is placed through a coaxial needle following a CT guided lung biopsy. Once deployed the plug absorbs water, swells, anchors and seals the biopsy tract to reduce pneumothorax complications.

Key Words:  BioSEAL, CT guided lung biopsy, hydrogel, pneumothorax, FNA.
Uses of Technology/Products/Service:
CT guided lung biopsy using biopsy needles is an extremely sensitive and specific method for the evaluation of indeterminate densities detected on CT and PET/CT imaging. Once the needle is removed, air can leak out of the lung into the surrounding pleural space resulting in a lung collapse. This creates stress for the patient, increased use of hospital, nursing and physician time to monitor the patient and requires chest tube placement and a hospital admission in 10-15% of patients at an average cost of $7000.00. Results from a randomized clinical trial of 300 patients in 17 sites in the U.S. demonstrated a statistically significant reduction in pneumothorax and chest tube rates in patients in the BioSEAL arm as compared to controls. The BioSEAL is commercially available in Europe and is awaiting final clearance from the FDA to be sold commercially in the U.S. A spinoff product, HydroMARK is a novel breast biopsy site marker with a water content of 90% rendering it highly visible under ultrasound imaging for 6 weeks or more. The HydroMARK has FDA clearance and will be released in the U.S. in the 4th quarter of 2008.

Benefit to Company:
With funding from the SBIR program, Biopsy Sciences was available to complete the initial development, proof of concept of the BioSEAL device and to secure a licensing agreement in which we received payments that allowed the company to conduct a clinical trial in order pursue FDA clearance. The BioSEAL was purchased by Angiotech Pharmaceuticals in 2008. Proceeds from that transaction have allowed Biopsy Sciences to hire clinical specialists and launch the HydroMARK in the U.S.

How Product Was Commercialized:
Biopsy Sciences’ large portfolio of patents covering the BioSEAL were acquired by Angiotech. The product is commercially available in Europe and once available in the U.S. will be sold by the Angiotech sales force in the U.S. and abroad. The HydroMARK is sold through a large network of distributors in the U.S. and Europe.