Multiple Publications and Presentations Underscore Seno Medical's Value Proposition in Mitigating the Cost and Burden of Unnecessary Breast Biopsies

SAN ANTONIO, Jan. 8, 2019 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today provided a summary of key 2018 data publications and presentations that demonstrate the clinical utility and healthcare economic benefits of its proprietary, cutting-edge technology.

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"Multiple publications and presentations over the course of 2018 substantially strengthen the body of evidence emphasizing the economic costs of unnecessary breast biopsies and the power of our Imagio^® Breast Imaging System to potentially reduce the number of these procedures," said Thomas Umbel, President and CEO of Seno Medical. "This growing evidence base further advances the compelling value proposition that Seno Medical offers to patients, physicians, and payers. We believe this robust body of evidence will help to position the Imagio system as a sound diagnostic tool for the breast imaging community. The selection of Imagio as a finalist for the 2018 Medtech Insight Awards in the 'Best Proof-of-Value of an Innovation' category demonstrates widespread recognition of our value proposition."

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Previously unreported data publications and presentations include:

• A cover article in Radiology reporting the results of a landmark study using OA/US imaging to diagnose benign and malignant breast masses. This study, which was based on results from 2,191 breast masses in 2,105 women, found that OA/US increases the specificity of breast mass assessment compared with ultrasound (US) alone. OA/US downgraded 40.8% of benign mass reads, with a specificity of 43.0% compared with 28.1% for US alone. OA/US exceeded US in specificity by 14.9% (P < .0001). Sensitivity for biopsied malignant masses was 96.0% for OA/US and 98.6% for US (P < .0001). The negative likelihood ratio (NLR) of 0.094 for OA/US indicates a negative examination can reduce a maximum US-assigned pretest probability of 17.8% (low Breast Image Reporting and Data System [BI-RADS] 4B) to a posttest probability of 2% (BI-RADS 3).¹
• A publication in Radiology of a European prospective, multi-center study evaluating OA/US in downgrading suspicious breast masses in 209 patients with 215 breast masses classified as BI-RADS 4a or 4b.² Results show that 47.9% of benign masses classified as BI-RADS 4a and 11.1% of masses classified as BI-RADS 4b were correctly downgraded to BI-RADS 3 or 2 with OA/US. Two of seven malignant masses classified as BI-RADS 4a at US were incorrectly downgraded, and one of 60 malignant masses classified as BI-RADS 4b at US was incorrectly downgraded for a total of 4.5% false-negative findings. The study authors conclude that benign masses classified as BI-RADS 4a could be downgraded in BI-RADS category with OA/US, which could potentially decrease negative biopsies for cancer and short-interval imaging follow-up examinations, with the limitation that a few masses may be inappropriately downgraded.
• A publication in Photoacoustics describing how OA/US imaging combined with US enables functional and anatomic mapping of the breast.³ The authors conclude that the OA/US co-registration technology enables increased accuracy of radiologist assessment of malignancy by confirming, upgrading and/or downgrading US BI-RADS categorization of breast tumors.
• A publication in the American Journal of Roentgenology that compared OA/US to histology in the evaluation of potentially malignant breast masses.⁴ A total of 92 masses (BI-RADS categories 3, 4 or 5) in 94 subjects were imaged with OA/US and assessed for three features internal to the tumor and two external features in the boundary zone and periphery. Mean OA/US scores were compared with histologic findings for masses that were biopsied and with benign masses. Results show that high OA/US scores, especially those based on the external features, have a high positive-predictive value (PPV) for malignancy, while low OA/US scores correlate with a low PPV for malignancy. The authors conclude that the functional component of OA/US may help address some of the limitations in discriminating between benign and malignant masses.
• A publication in the American Journal of Roentgenology that reports the outcomes of a pilot study assessing the potential of OA/US to improve BI-RADS categorization of breast masses.⁵ In this study, breast masses assessed as BI-RADS category 3, 4A-C, or 5 by radiologists underwent gray scale ultrasound (US) and OA/US and were then re-categorized. Of 94 total masses, 39 were proven by biopsy to be malignant, 44 were benign and 11 BI-RADS category 3 masses were stable at 12-month follow up. The sensitivity of OA/US and US was 97.1%, while specificity, was 44.3% and 36.4%, respectively. OA/US enabled downgrading of masses stable at 12-month follow-up (41.7% downgraded from 3 to 2; 36.6% of 4A downgraded to 3 or 2; 10.1% downgraded from 4B to 3 or 2). OA/US also resulted in upgrading of 75.0% of the malignant masses classified as category 4A, 4B, 4C, or 5, and 49.4% of the malignant masses were classified as category 4B, 4C, or 5. These results demonstrate that OA/US enables the potential downgrading of benign masses and upgrading of malignant masses compared with US.

Previously reported data include:

• At the December 2018 San Antonio Breast Cancer Symposium, Seno's Medical Director, Dr. Gisela Menezes, presented how the company's OA/US may play a role in non-invasively offering breast cancer prognostic information at the molecular level. This prospective 5-center study was performed in the Netherlands between March 2015 and February 2016 and included 209 patients with 215 breast lesions. Study results indicated that OA/US feature scores may correlate to breast cancer molecular subtypes, with the potential of helping establish an earlier prognosis and treatment plan.⁶
• A presentation at the Radiological Society of North America 2018 Annual Meeting describing the results of a study investigating the potential role of functional OA/US imaging-derived hemoglobin de-oxygenation and angiogenesis feature scoring combined with conventional gray-scale US in non-invasively diagnosing breast cancer molecular subtypes.⁷ The data demonstrate that functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The study authors conclude that data from such subtype analyses may help facilitate clinical management decisions.
• A publication in ClinicoEconomics and Outcomes Research that found the annual U.S. cost of false-positive breast biopsies exceeds $2 billion.⁸ The study also found that nearly $8 billion is spent annually on follow-up breast diagnostic procedures (mammograms, ultrasound and biopsies). The study authors emphasized the need for highly effective tools that can exclude patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures.
• A publication in the American Journal of Roentgenology describing a novel advanced statistical method for downgrading the risk classification of breast masses to reduce the need for unnecessary breast biopsies.⁹ This method, the NLR, can be used with diagnostic imaging output to downgrade breast mass risk classification. The use of the NLR along with BI-RADS 4 subcategories can help to reduce the number of false-positives without experiencing excessive negative results that would lead to cancer going undiagnosed.

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 opto-acoustic 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 Imagio 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.

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¹ Neuschler EI, Butler R, Young CA, Barke LD, Bertrand ML, Bohm-Velez M, et al. A pivotal study of optoacoustic imaging to diagnose benign and malignant breast masses: a new evaluation tool for radiologists. Radiology. 2018:287(2):398-412.

² Menezes GLG, Pijnappel RM, Meeuwis C, Bisschops R, Veltman J, Lavin PT, et al. Downgrading of breast masses suspicious for cancer by using optoacoustic breast imaging. Radiology. 2018;288(2):355-365.

³ Oraevsky AA, Clingman B, Zalev J, Stavros AT, Yang WT and Parikh JR. Clinical optoacoustic imaging combined with ultrasound for coregistered functional and anatomical mapping of breast tumors. Photoacoustics. 2018;12:30-45.

⁴ Butler R, Lavin PT, Tucker FL, Barke LD, Bohm-Velez M, Destounis S, et al. Optoacoustic breast imaging: imaging-pathology correlation of optoacoustic features in benign and malignant breast masses. AJR 2018;211:1155-1170.

⁵ Neuschler EI, Lavin PT, Tucker FL, Barke LD, Bertrand ML, Bohm-Velez M, et al. Downgrading and upgrading gray-scale ultrasound BI-RADS categories of benign and malignant masses with optoacoustics: a pilot study. AJR 2018;211:689-700.

⁶ Menezes GLG, Mann RM, Meeuwis C, Bisschops B, Veltman J, Lavin PT, van de Vijver MJ, Pijnappel RM. Can optoacoustic imaging combined with ultrasound non-invasively offer prognosis for breast cancer molecular subtypes? SABCS 2018 Poster Presentation.

⁷ Moy L, Dogan BE, Menezes GD, Neuschler EI, Butler RS, Stavros AT, et al. Optoacoustic imaging (OA) is helpful in predicting breast cancer molecular subtypes. Presented at RSNA 2018 on November 26. Abstract SPS126B.

⁸ 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. ClinicoEcon Outcomes Res. 2018;10:157-167.

⁹ Yang WT, Parikh JR, Stavros AT, Otto P and Maislin G. Exploring the Negative Likelihood Ratio and How It Can Be Used to Minimize False-Positives in Breast Imaging. AJR 2018;210:301-306.

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