The PIONEER Study was conducted in 16 leading institutions throughout the U.S., with more than 2,100 subjects enrolled. The study was designed to measure the sensitivity and specificity of Imagio compared to grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects underwent a traditional ultrasound and an Imagio scan. The radiologist used clinical mammography and traditional ultrasound findings to determine if the subject should advance to the biopsy phase. The Imagio results were later interpreted by an independent reader panel. Subjects who were put into follow-up were re-evaluated 12 months after their initial examination to confirm the results as a true negative.

"We are pleased to have completed the final phase for the PIONEER Study. I would like to thank our sites and readers for their commitment to this important milestone," said Tom Miller, CEO of Seno Medical Instruments. "This represents an important achievement in Seno's mission to help improve the diagnostic process for breast cancer. This product shows promise for improving the diagnosis of suspicious breast lesions in hundreds of thousands of women across the U.S."


After the interim analysis of the PIONEER Study, Seno initiated a separate European Post Marketing and Clinical Follow-up Study, the MAESTRO Study. The company currently has five sites participating in this study in the Netherlands.

Results from the MAESTRO Study will be presented at the upcoming 2015 European Society of Breast Imaging Annual Scientific Meeting (EUSOBI), the second largest conference dedicated to breast cancer imaging. The EUSOBI meeting will take place on October 2–3 in London. The results of the PIONEER Pilot Study will be presented at the Radiological Society of North America Annual Meeting (RSNA), the premiere conference in the world for radiology, from November 29 – December 4 in Chicago, Illinois.

According to the American Cancer Society, an estimated 231,840 new cases of invasive breast cancer, along with 60,290 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2015. An estimated 40,290 women in the U.S. are expected to die in 2015 from breast cancer. Only lung cancer accounts for more cancer deaths in women.

"Despite breast cancer being one of the leading causes of death in women, physicians are still quite limited by the diagnostic tools currently available," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno Medical Instruments. "The opto-acoustics technology utilized by Imagio is a potential solution in providing clinicians with a less invasive method to rule out cancer, which could help improve both the patient/physician experience and economic outcomes."

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