Study Demonstrates Superiority of Delphinus’s Ultrasound Tomography System, SoftVue, in Conjunction with Mammography for Breast Cancer Screening in Women with Dense Breasts

Now published in Radiology, results are based on a comparison with screening for breast cancer using mammography alone

Delphinus Medical Technologies, a pioneering medical imaging company that developed the SoftVue™ Breast Ultrasound Tomography (UST), announced today the publication of a study comparing mammography in conjunction with SoftVue UST vs mammography alone in women with dense breasts. The study concluded that in women with dense breasts, mammography plus SoftVue UST improved cancer detection by radiologists versus mammography alone. The article “Comparison of Mammography and Mammography with Supplemental Whole-Breast US Tomography for Cancer Detection in Patients with Dense Breasts” has been published in the peer-reviewed journal, Radiology.

“This study demonstrates the benefits of supplemental ultrasound tomography screening for women with dense breasts,” said Dr. Mary Yamashita, Section Chief of Breast Imaging and Clinical Professor of Radiology and Surgery at the University of Southern California, Keck School of Medicine. “Our findings revealed an increase in cancer detection and a significant improvement in BIRADS 3 specificity when SoftVue UST was used alongside mammography. The enhanced specificity can empower radiologists to better differentiate benign masses (BIRADS 2), ultimately reducing the need for short-term follow-ups for our patients.”

Among 140 cases included in the multi-reader, multi-case study, mammogram plus SoftVue UST demonstrated superiority in cancer detection compared to mammography alone. Thirty-two Mammography Quality Standards Act-qualified radiologists from academic, private, and community-based practices in diverse areas participated in the study. For each case, readers independently evaluated the mammogram and assigned a Breast Imaging Reporting and Data System (BI-RADS) score. They then assessed the mammogram plus UST for the same case and assigned a separate BIRADS assessment.

The authors concluded:

1. Adding SoftVue UST to screening mammography showed statistical superiority in the performance of breast cancer detection in women with dense breasts compared with mammography alone.
2. Adding SoftVue UST to screening mammography led to a statistically significant 25% improvement in sensitivity for breast cancer detection of BI-RADS 4 or higher lesions compared with mammography alone.
3. Adding SoftVue UST to screening mammography led to a statistically significant 8% improvement in specificity for BI-RADS 3 lesions compared with mammography alone.

“SoftVue provides a unique solution that has been missing in dense breast screening. As a breast imager it is exciting to see a screening technology that not only increases cancer detection, but also allows us to reduce the number of short-term follow-ups. This means more women who have breast cancer will be referred for biopsy immediately and more women without breast cancer will be reassured they do not need follow-up,” said Dr. Elise Berman, Medical Director, Delphinus Medical Technologies.

Breast cancer screening with mammography reduces mortality by 41% in women with non-dense breasts but reduces mortality by only 13% in women with dense breasts. The U.S. government has also reinforced the importance of supplemental screening by mandating federal breast density notifications to be sent to each affected patient, effective September 2024.

SoftVue UST paired with mammography provides a new annual screening solution for women with dense breasts and is the only ultrasound-based breast imaging system that is FDA-approved for same-day screening as mammography.

About Delphinus Medical Technologies, Inc.

Headquartered in Novi, Michigan, Delphinus Medical Technologies, Inc., is a pioneering medical imaging company that developed SoftVue™, featuring the first circular array transducer technology. The patented technology is a 3D whole-breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan. To learn more, visit our website and follow us on LinkedIn.

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