Results Presented in a High Impact Clinical Trial Session at the Radiology Society of North America (RSNA) Annual Meeting
CHICAGO, November 27, 2017 – Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today announced positive data from PIONEER, a Phase III pivotal trial of its Imagio™ breast imaging system. The study found that OA/US was more specific than device gray-scale ultrasound alone (US) in differentiating malignant from benign breast lesions and was non-inferior to US with respect to sensitivity. This means that OA/US detected a similar number of malignant lesions as US but had a lower rate of false positive malignant diagnoses. These data were highlighted during an oral presentation by a principal investigator involved with the study at the Radiology Society of North America 103rd Annual Meeting, taking place November 26 – December 1 in Chicago.
PIONEER was a U.S., prospective, multi-institutional study that enrolled 2,105 women over the age of 18 years. All participants had a breast mass assessed by initial conventional site ultrasound as BI-RADS (Breast Imaging and Reporting Data System, or BR) category 3, 4, or 5. The likelihood that a breast mass is malignant increases with increasing BR category number. Radiologists at each clinical site also assigned each mass a probability of malignancy (POM) ranging from 3% to 99% based on mammographic and US features. Patients with masses categorized as > BR4A had OA/US prior to undergoing core needle biopsy within 45 days of their initial visit and subsequent biopsy or excision surgery within 45 of the initial biopsy. Patients with BR3 masses had OA/US upon enrollment and underwent biopsy or conventional site US and OA/US 12 months after enrollment. Patients who underwent biopsy due to new clinical or imaging findings within the 12-month period had additional OA/US imaging within 45 days prior to the biopsy. Independent breast imagers who were blinded to the biopsy and other clinical information read the OA/US and device US images; an independent central pathologist who was blinded to the imaging data reviewed all of the biopsy reports.
Key findings from the study include:
“These data demonstrate that OA/US improved diagnostic specificity compared with US, resulting in reclassification of both benign and malignant lesions,” said Erin Neuschler, M.D., Assistant Professor of Radiology at the Northwestern University Feinberg School of Medicine and the co-principal investigator of the PIONEER study. “The ability to downgrade the BI-RADS assessment of some benign masses may lead to fewer false positive examinations, short-term interval follow-up studies, and benign biopsies, potentially improving the accuracy of the diagnostic work-up and reducing some of the limitations and perceived harms of breast imaging.”
“This pivotal trial supports the Imagio system as an important advancement in evaluating breast masses and more accurately differentiating malignant and benign lesions,” said Tom Umbel, CEO of Seno Medical Instruments. “OA/US offers patients and clinicians an alternative diagnostic method that may increase specificity without significantly impacting sensitivity. False positive examinations and negative biopsies increase women’s anxiety, pain and radiation exposure, and are a contributing factor in non-compliance with current breast cancer screening recommendations. The Imagio OA/US system shows the potential to positively affect these concerns and reduce healthcare costs in the process.”
The Imagio™ breast imaging system was designed and is being studied to identify two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood that occurs in cancer compared to benign masses and normal tissues. The technology is CE marked in Europe and the subject of a U.S. PMA filing with the FDA.
About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio™ breast imaging system fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The OA/US images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.
About Breast Cancer
According to the American Cancer Society, an estimated 252,710 new cases of invasive breast cancer, along with 63,410 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2017. An estimated 40,610 women in the U.S. are expected to die in 2017 from breast cancer. Only lung cancer accounts for more cancer deaths in women.
Breast Cancer Facts & Figures, American Cancer Society (2017). Accessed on October 24, 2017: https://www.cancer.org/research/cancer-facts-statistics/breast-cancer-facts-figures.html