SUREcore biopsy needle

PROSTATE BIOPSY

The Clinical Need

Prostate Biopsy

Prostate biopsy is the definitive test for the diagnosis of prostate cancer. An estimated 2 million procedures are performed annually in the United States. The current standard of care prostate biopsy when compared to surgical pathology, either underestimates or overestimates the severity of the disease up to 40% of the time, particularly in men with equivocal disease. Although significant advances have been in made in imaging, histologic analysis and genomic testing, the core biopsy needle and methods to retrieve tissue specimens have not changed in decades. Increased options to treat prostate cancer have created the need to improve the diagnostic performance of prostate biopsy to provide the patient with the appropriate treatment regimen.

The most common biopsy needle designs are prone to deflection, resulting in as much as a 50% reduction in the volume of tissue sampled.

THE COMPLETE SOLUTION

SUREcore Prostate Biopsy Needle

The SUREcore needle prevents needle deflection and movement of the tissue core during amputation and recovery by keeping it in a cradle-like core collector to preserve tissue integrity and eliminate artifact.

In head-to-head comparisons with standard of care biopsy needles, the SUREcore needle consistently delivered significantly more tissue volume by weight and higher tissue integrity with reduced sample to sample variability.

The company is developing other biopsy instruments to complete its portfolio of prostate and soft tissue biopsy products.

Biopsy Method

coreCARE Specimen Retrieval Kit

Current methods of biopsy tissue specimen retrieval are not standardized and often result in tissue fragmentation and/or distortion and artifact all of which impede accurate histologic analysis.

The coreCARE specimen retrieval cartridge uses a proprietary compound to capture and retrieve the biopsy specimen from the biopsy needle using a single step “touch and go” technique to