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Ultrasound plus opto-acoustic imaging for breast lesions: Five questions with Seno Medical

by Gus Iversen, Editor in Chief | December 26, 2023
Women's Health
A study presented at RSNA found that Seno Medical’s Imagio Breast Imaging System with opto-acoustic ultrasound (OA/US) is more cost-effective than ultrasound alone in evaluating suspicious breast lesions.

The OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Together, the capabilities help physicians characterize and differentiate suspicious breast lesions that may — or may not — require more invasive diagnostic evaluation.

The study, which was awarded the 2023 RSNA Trainee Research Prize, discussed the significant medical and economic burdens of benign biopsies, which OA/US can help mitigate. Breast biopsy procedures caused by false-positive assessments in the U.S. cost more than $2 billion per year and cause millions of women unnecessary stress and anxiety.

In their analysis, the researchers found that the net monetary benefit (NMB) of OA/US was $1,495.36 per patient, which the study found to be greater value than ultrasound alone. The calculated incremental cost-effectiveness radio (ICER) from the model analytics is $-31,715.82/QALY (quality adjusted life year) for OA/US, which is significantly more cost-effectiveness than ultrasound. Comparatively, anything lower than $100,000/QALY is considered cost-effective.

HCB News reached out to Seno Medical with five questions to learn more about the Imagio Breast Imaging System. That conversation is below, edited for length.

1: Who are the best candidates for OA/US imaging? Is Imagio a secondary imaging modality to mammography?
The best candidates for our technology are any breast center, breast imaging department, radiology department that does diagnostic imaging or diagnostic work ups for breast cancer versus a center that does strictly breast cancer screening.

Our technology is approved as an adjunct to screening mammography or other screening modality. Basically, Imagio OA/US is considered a first order diagnostic work-up after a suspicious mass on screening or a palpable mass.

2: What does the Imagio install base look like today?
We are very early in our commercialization with the hiring, mid-year, of eight sales professionals. We currently have one installation in a busy physician-owned breast center in a medium-sized city in North Carolina. We currently have two academic sites scheduled for training and many more that we expect closing by year end or early next year. We anticipate that the adoption of the Imagio OA/US technology will follow the 3D tomosynthesis introduction and replace a dedicated breast ultrasound room one room at a time — much like Tomo did over time with mammogram units.

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