One of the important decisions that a person diagnosed with prostate cancer must consider is how they should best treat or manage their disease. This choice is affected by a number of factors, including the many possible negative side-effects of treatment and the patient’s age and overall health. As one of the slowest growing cancers, an increasing number of men are electing to forgo aggressive treatment and actively monitor their disease instead. If this “active surveillance” alternative is chosen, the patient will usually undergo semi-annual examinations including use of DRE and PSA testing. However, because of the low predictive value of these two tests, physicians and patients will want to incorporate additional clinical assessments and objective measures that can document the progression of their disease. The National Cancer Institute estimates that there are approximately 2.4 million men living in the U.S. who have a history of cancer of the prostate.
We believe that, subject to FDA clearance for such use, the ProUroScan System will be used as an adjunctive tool to DRE and PSA testing in monitoring changes in the prostate over time. The ProUroScan System is designed to produce an elasticity image of the prostate as an adjunctive aid in visualizing and documenting abnormalities of the prostate that have been detected by digital rectal examination. By creating a digital record of an exam that can be stored and retrieved, the ProUroScan System will allow physicians to compare new images to those generated in previous exams. Use of the system to make longitudinal comparisons will require us to obtain additional regulatory approvals or clearances and file additional submissions with the FDA to obtain expanded labeling claims. Such regulatory approvals or clearances may require us to perform additional clinical studies.