New study shows advantage for Novi startup’s breast exam technology

NOVI—The ultrasound breast examination technology being developed by a Novi medical device startup, Delphinus Medical Technologies Inc., has been shown to be predictive of future breast cancers, according to a new study recently published in the Journal of Clinical Medicine.

The study was conducted by researchers at the National Cancer Institute, the Karmanos Cancer Institute, Wayne State University, Henry Ford Health Systems, The Mayo Clinic and George Washington University and was supported by a contract from the National Cancer Institute, part of the National Institutes of Health.

Mammographic percent density (MPD) is an independent risk factor for developing breast cancer. MPD only modestly improves breast cancer risk prediction and is not typically assessed in women under 40 because of concerns of exposing them to more ionizing radiation from X-rays. Previous studies have shown that tissue sound speed, derived from ultrasound tomography, which uses ultrasound instead of tissue-damaging X-rays, is a potential surrogate marker of breast density. But prior to this study, sound speed has not been directly linked to breast cancer risk. The study evaluated the relationship of sound speed, using Delphinus’ SoftVue 3D whole breast ultrasound system, and MPD with breast cancer risk in a case-control study. This study compared 61 patients with a recent breast cancer diagnosis with 165 women with no personal history of breast cancer.

This study demonstrated that increasing quartiles of whole breast volume-averaged sound speed were consistently and more strongly associated with increasing breast cancer risk than quartiles of mammographic percent density. These findings were statistically significant and suggest future opportunities for using UST-breast cancer risk assessment, particularly in younger women with the absence of ionizing radiation.

“This study suggests that whole breast ultrasound tomography may provide stronger and more specific information about that risk than mammography, which may ultimately help to stratify the risk in order to suggest more personalized screening and interventions,” said Dr. Rachel Brem, Director, Breast Imaging and Intervention at The George Washington University and the Program Leader, Breast Cancer, at The George Washington Cancer Center. “We are encouraged by the study results that indicate the potential use of whole breast ultrasound to improve the accuracy of breast cancer risk assessment with a non-ionizing breast imaging modality.”

Added Neb Duric, Delphinus chief technology officer: “This study expands the potential application of our platform SoftVue technology beyond diagnostic imaging and breast cancer screening to cancer risk stratification for women at virtually any age, including the approximately 70 million women in the U.S. that are below screening age. We believe that SoftVue imaging may enable individual risk assessment and intervention at an early age, when interventions are the most effective, as well as personalized screening regimens that take into account risk levels.”

Delphinus has developed SoftVue, featuring the first circular array transducer technology that has received sequential U.S. Food and Drug Administration clearances. The patented technology is a 3D whole breast ultrasound imaging device that delivers no radiation, requires no compression, and images the entire breast with a single scan. Delphinus was founded as a spinout of the Karmanos Cancer Institute in Detroit and is capitalized through principal investments by Arboretum Ventures, Ann Arbor; Beringea, Farmington Hills; North Coast Technology Investors, Ann Arbor; Venture Investors, Madison, Wis., Hopen Life Science Ventures, Grand Rapids; and Waycross Ventures, Menlo Park, Calif. For more information, visit www.delphinusmt.com.

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