Seno Medical Instruments' Imagio™ Opto-Acoustic Breast Imaging System Demonstrates Ability to Downgrade Risk Classification of Benign Breast Masses in a Prospective European Clinical Trial

The prospective, controlled, multi-center study was conducted at five centers in the Netherlands between March 2015 and February 2016 and enrolled 217 patients at least 18 years of age with at least one breast mass totaling 223 breast masses classified as BI-RADS (Breast Imaging and Reporting Data System) category 4A or 4B and with a corresponding probability of malignancy (POM) ranging from >2% to 50% based on prior US assessment. The likelihood that a breast mass is malignant increases with increasing BI-RADS category number. All subjects underwent an OA/US evaluation after conventional US and prior to biopsy. The OA/US data were used to estimate the POM on a scale from 0% to 100% and, when appropriate, the BI-RADS classification determined by conventional US was adjusted. Biopsies were performed within 30 days of enrollment and after the OA/US procedure had been performed and interpreted. The OA/US results were compared with biopsy results as the reference standard. Patients were asked to complete a satisfaction survey after undergoing OA/US evaluation

"The negative consequences of biopsies of benign breast masses include pain, anxiety, fear, direct expenses and indirect expenses related to work missed and managing complications," said study investigator Gisela L.G. Menezes, M.D., Ph.D. and postdoc at the University Medical Center Utrecht, the Netherlands. "Using OA/US, benign masses originally classified as suspicious may be downgraded to probably benign or benign, potentially decreasing the number of biopsies of benign lesions."

Key findings from the study include:

• In the intent to diagnose (ITD) population of 209 patients with 215 masses, 68% were benign, 31.1% were malignant and 0.9% were considered high-risk lesions based on histopathology of biopsy specimens.
• Based on US of 146 benign lesions, 81.5% and 18.5% were classified as BI-RADS 4A and 4B, respectively. Sixty benign masses were correctly downgraded from BI-RADS 4A or 4B to BI-RADS 3 or 2 with OA/US (p<0.0001).
• Of benign masses classified as BI-RADS 4A, 47.9% were downgraded to BI-RADS 3 or 2 and 12.3% were upgraded to 4B.
• Of 27 benign masses classified as 4B, 11.1% were downgraded to BI-RADS 3, 6.1% were upgraded to 4C and 0.6% were upgraded to 5.
• Overall, 41.1% of benign breast masses originally classified as BI-RADS 4A or 4B on US could be downgraded to probably benign or benign masses (BI-RADS 3 or 2) with OA/US, and 49.2% of malignant breast masses could be upgraded to a higher BI-RADS category.
• The OA/US true positive rate was 95.5%.
• There were no safety issues related to OA/US.
• The patient satisfaction survey showed that approximately 95% of the patients agreed that OA/US had an acceptable level of comfort and 84% agreed that OA/US scan time was acceptable.

"The results from this study indicate that a substantial percentage of breast masses classified as BI-RADS 4A or greater, based on conventional US, can be downgraded with OA/US. This suggests that the functional and morphologic information gained with OA/US has the potential to benefit women undergoing breast mass evaluation," said Tom Umbel, CEO of Seno Medical Instruments. "Detection of a breast mass can make a woman very anxious, and it is incumbent on everyone involved in assessing breast masses to minimize patients' stress and anxiety while providing the most accurate diagnosis possible. We believe that the Imagio system has an important role to play in improving breast cancer diagnosis and ensuring optimal patient care and outcomes."

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 has its CE mark in Europe and is 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.¹

Media Contact
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¹ 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

SOURCE Seno Medical Instruments, Inc.

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