We report on findings from the clinical feasibility study of the Imagio™. Breast Imaging System, which acquires two-dimensional opto-acoustic (OA) images co-registered with conventional ultrasound using a specialized duplex hand-held probe. Dual-wavelength opto-acoustic technology is used to generate parametric maps based upon total hemoglobin and its oxygen saturation in breast tissues. This may provide functional diagnostic information pertaining to tumor metabolism and microvasculature, which is complementary to morphological information obtained with conventional gray-scale ultrasound. We present co-registered opto-acoustic and ultrasonic images of malignant and benign tumors from a recent clinical feasibility study. The clinical results illustrate that the technology may have the capability to improve the efficacy of breast tumor diagnosis. In doing so, it may have the potential to reduce biopsies and to characterize cancers that were not seen well with conventional gray-scale ultrasound alone.