Study Finds Opto-Acoustic Imaging Provides Significant Cost Benefits When Compared to Ultrasound Alone in Evaluation of Breast Lesions

Imagio^® System’s unique hybrid modality helps doctors better characterize suspicious breast lesions to avoid unnecessary invasive biopsies and improve patient care.

[San Antonio, TX – November 30, 2023]  A study presented at RSNA and published in Academic Radiology has found that Seno Medical’s Imagio^® Breast Imaging System with opto-acoustic ultrasound (OA/US) imaging is more cost effective when compared to ultrasound alone in evaluating suspicious breast lesions.ⁱ Imagio’s^® non-invasive opto-acoustic ultrasound (OA/US) technology provides functional real-time information about suspicious breast lesions, helping physicians characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation. 

The presentation, Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis, was presented at RSNA on Thursday, November 30, by B. Bersu Ozcan, M.D. (Research Fellow, Department of Radiology, UT Southwestern), and discusses the need to improve diagnostic performances of imaging studies to reduce the significant medical and economic burdens of benign biopsies. The presentation was awarded the 2023 RSNA Trainee Research Prize.

The analysis highlights the cost effectiveness of the OA/US modality compared to ultrasound (US) alone, taking into consideration incremental cost effectiveness ratio (ICER) compared to willingness to pay (WTP) and how that affects the incremental net monetary benefit (NMB) and quality of life benefits for a comparative technology. 

Key takeaways:

• The model indicated that the net monetary benefit (NMB) of OA/US was $1,495.36 per patient, the value that is obtained from the money invested in the technology, 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. Comparatively anything lower than $100,000/QALY is considered cost effective. The ICER comparison show OA/US as significantly more cost effectiveness than US.
• The probabilistic sensitivity analysis was run on over 10,000 iterations and OA/US remained as the more cost-effective strategy in 98.69% of the iterations.

The authors concluded, “OA/US is more cost-effective than US to differentiate benign or malignant breast masses in the diagnostic setting. It can reduce costs while improving patients’ quality of life, primarily by reducing false-positive results with consequent benign biopsies.”

Mammograms are an essential part of preventive healthcare, and when an initial review reveals a suspicious lesion, additional imaging and/or invasive breast biopsies could be the next step in diagnosis. However, breast biopsy procedures caused by false-positive assessments in the United States cost the healthcare system more than $2 billion per yearⁱⁱ and cause millions of women unnecessary stress and anxiety. 

Imagio^® OA/US technology combines laser optics and grayscale ultrasound to offer 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. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and deoxygenation — the Imagio^® OA/US Breast Imaging System is a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. 

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com. 

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ⁱ Ozcan BB, Xi Y, and Dogan BE. Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis. Acad Rad 2023;08.042.

ⁱⁱ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.