The SoftVue clinical prototype was tested in order to substantiate our claim that breast cancer can be identified on the basis of its acoustic signature. To date, our ongoing clinical studies indicate that SoftVue can differentiate benign masses from malignant masses that are greater than five millimeters in size. Additional studies have confirmed the ability of SoftVue to measure tumor changes over time, an important capability for tracking tumor response in patients undergoing breast cancer treatment and for early detection over time, or even watchful waiting scenarios. Furthermore, it has been shown that SoftVue can measure breast parameters that predict breast cancer risk. Similar to magnetic resonance imaging (MRI) of the breast evolving quantitative assessments of dynamic contrast enhancement (DCE), major strengths of SoftVue are the objective assessments that can be made by combining transmission parameters with the more qualitative assessments of reflection imaging alone. These clinical results signal SoftVue’s readiness to transition from our clinical prototype to the broader commercial stage.
The following clinical studies are being conducted at the Karmanos Cancer Institute in Detroit, MI.
Summary of Clinical Study Results
On the basis of the results from clinical studies above, we have concluded that SoftVue could play a potentially important role in a diagnostic continuum that includes breast cancer detection, biopsy reduction, treatment monitoring, watchful waiting and risk assessment. In such a role, SoftVue offers a number of advantages over existing imaging modalities. These advantages are summarized in the table below.
"SoftVue is currently under development and has not received clearance from the FDA at this time"