{"id":5162,"date":"2016-12-08T20:38:27","date_gmt":"2016-12-08T20:38:27","guid":{"rendered":"https:\/\/senomedical.com\/?p=5162"},"modified":"2025-06-16T20:38:56","modified_gmt":"2025-06-16T20:38:56","slug":"new-data-presented-at-san-antonio-breast-cancer-symposium-confirms-correlation-between-the-imagio-opto-acoustic-breast-imaging-system-and-histologic-grade-of-breast-masses","status":"publish","type":"post","link":"https:\/\/senomedical.com\/index.php\/2016\/12\/08\/new-data-presented-at-san-antonio-breast-cancer-symposium-confirms-correlation-between-the-imagio-opto-acoustic-breast-imaging-system-and-histologic-grade-of-breast-masses\/","title":{"rendered":"New Data Presented at San Antonio Breast Cancer Symposium Confirms Correlation Between the Imagio\u2122 Opto-Acoustic Breast Imaging System and Histologic Grade of Breast Masses"},"content":{"rendered":"<p><strong>Additional Data Validates Potential of Imagio\u2122 Opto-Acoustic Breast Imaging System to Reduce Negative Biopsies<\/strong><\/p>\n<p>NEWS PROVIDED BY Seno Medical Instruments, Inc. Dec 09, 2016, 07:00 ET SAN ANTONIO, Dec. 9, 2016 \/PRNewswire\/ \u2014 Seno Medical Instruments, Inc.,\u00a0the company pioneering the development of opto-acoustic (OA) technology as a new tool to improve the process of diagnosing breast cancer, today announced results from two analyses of the company\u2019s European MAESTRO post-market surveillance study. The two analyses were presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.<\/p>\n<p>MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of OA to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio\u2122 OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study.<\/p>\n<p>The first analysis evaluated the correlation between OA imaging results and histologic data of breast masses and found that there was a statistically significant correlation between the OA breast imaging results and those based on\u00a0histopathologic analysis.<\/p>\n<p>\u201cThese studies are an important step forward in the development of noninvasive breast imaging technology. Evaluation of the Imagio\u2122 system significantly included an independent analysis of the patient\u2019s pathology, unparalleled in the pre-release development of any breast imaging technology,\u201d said F. Lee Tucker, MD, FCAP and pathologist for the PIONEER study in the U.S. \u201cThe findings indicate the Imagio\u2122 system can provide an accurate and noninvasive differentiation of benign from cancerous breast masses and will be an important means of reducing the number of benign breast biopsies.\u201d<\/p>\n<p>The histopathological examination revealed 146 benign masses and 67 malignant masses. For each mass, five pre-determined OA features, three internal features, and two external features were evaluated. The three internal scores (vessels, blush, and hemoglobin) and two external features (capsular boundary zone and peripheral boundary zone) were summed together and separately for testing relationships utilizing traditional histopathology measures. The OA feature scores statistically significantly differentiate between benign and malignant masses and appear to correlate to histologic grade.<\/p>\n<p>The second study, an interim analysis from the MAESTRO study, presented OA imaging downclassification and upclassifciation data, which showed that the Imagio\u2122 system improved physicians\u2019 ability to accurately classify breast masses as malignant or benign compared to using traditional ultrasound. Results from this study were first presented at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world dedicated to breast cancer imaging, in September 2016\u00a0in\u00a0Paris.<\/p>\n<p>\u201cThe interim results from the MAESTRO study provide further evidence in a real-world setting, that the Imagio breast imaging system is a viable diagnostic tool to more accurately assess breast masses for malignancy compared to diagnostic ultrasound,\u201d said Ruud Pijnappel MD, PhD, Professor Breast Radiology at UMC Utrecht, Netherlands and CEO of LRBC \u2013 Dutch Reference Centre for Screening. \u201cWe believe the final results of the MAESTRO study to be presented in 2017 will confirm these interim results.\u201d<\/p>\n<p>\u201cTogether, the two data presentations presented at the San Antonio Breast Cancer Symposium reinforce our belief that the Imagio breast imaging system will be an important tool to clinicians to evaluate suspicious masses while providing greater comfort to the patient,\u201d said Tom Umbel, CEO of Seno Medical Instruments. \u201cWe will soon launch the Imagio system in Europe and look forward to the presenting the MAESTRO final results and the results of our pivotal trial in the US \u2013 PIONEER \u2013 in 2017.\u201d<\/p>\n<p>Seno Medical Instruments expects to announce the final results from the MAESTRO study in early 2017. Results from the company\u2019s PIONEER study in the U.S. of more than 2,000 patients are expected to be announced in the second half of 2017. Seno Medical is targeting their PMA submission for the Imagio system to the U.S Food and Drug Administration in early 2017.<\/p>\n<p>Seno\u2019s Imagio system co-registers and fuses opto-acoustics, a technology based on \u201clightin and sound-out,\u201d with diagnostic ultrasound \u2013 (OA\/US). The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio OA\/US breast imaging system\u00a0provides real-time images of these networks and a map of relative oxygen-rich or oxygendepleted blood. Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents or radio-isotopes to obtain its information, thereby reducing the patient\u2019s exposure to any potentially harmful aspects of imaging.<\/p>\n<p><strong>About Seno Medical Instruments, Inc.<\/strong><\/p>\n<p>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\u2019s Imagio breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique color map in and around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer \u2013 angiogenesis and deoxygenation \u2013 Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities \u2013 without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno\u2019s platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to neoadjuvant chemotherapy or hormonal treatments of breast cancer. To learn more about Seno\u2019s optoacoustic imaging technology and applications, visit http:\/\/www.SenoMedical.com<\/p>\n<p><strong>About the San Antonio Breast Cancer Symposium<\/strong><\/p>\n<p>The San Antonio Breast Cancer Symposium is an international symposium directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic, and radiation oncology, as well as other appropriate health care professionals. Approximately 7,500 attendees from more than 90 countries are expected to attend.<\/p>\n<p><strong>About Breast Cancer<\/strong><\/p>\n<p>According to the American Cancer Society, an estimated 246,660 new cases of invasive breast cancer, along with 61,000 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2016. Additionally, there are over 1.6 million biopsies performed annually and recent reported data noted an 81% \u201cfalse positive\u201d rate of biopsy procedures \u2013 the portion of biopsies that do not lead to breast cancer surgery. \u00a0\u00a0An estimated 40,450 women in the U.S. are expected to die in 2016 from breast cancer. Only lung cancer accounts for more cancer deaths in women. \\<\/p>\n<p><strong>Media Contact<\/strong><\/p>\n<p>Erich Sandoval Lazar Partners Ltd.\u00a0 Tel: +1 213-908-6226 Email:\u00a0\u00a0esandoval@lazarpartners.com<\/p>\n<p>1.J Womens Health, September 2014, Vol. 23:S1,<\/p>\n<p>2.An Actuarial Analysis of Breast Cancer Screening and Follow-on Diagnostics in a Commercially Insured Population.(2014).Millman, Inc., NY. http:\/\/www.milliman.com\/uploadedFiles\/insight\/2014\/actuarial-analysis-breast-cancer-screening.pdf<\/p>\n<p>3.U.S. Breast Cancer Statistics | Breastcancer.org. (2016). Breastcancer.org. http:\/\/www.breastcancer.org\/symptoms\/understand_bc\/statistics SOURCE Seno Medical Instruments, Inc. Related Links http:\/\/www.senomedical.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Additional Data Validates Potential of Imagio\u2122 Opto-Acoustic Breast Imaging System to Reduce Negative Biopsies NEWS PROVIDED BY Seno Medical Instruments, Inc. Dec 09, 2016, 07:00 ET SAN ANTONIO, Dec. 9, 2016 \/PRNewswire\/ \u2014 Seno Medical Instruments, Inc.,\u00a0the company pioneering the development of opto-acoustic (OA) technology as a new tool to improve the process of diagnosing [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-5162","post","type-post","status-publish","format-standard","hentry","category-press-releases"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Data Presented at San Antonio Breast Cancer Symposium Confirms Correlation Between the Imagio\u2122 Opto-Acoustic Breast Imaging System and Histologic Grade of Breast Masses - Seno Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/senomedical.com\/index.php\/2016\/12\/08\/new-data-presented-at-san-antonio-breast-cancer-symposium-confirms-correlation-between-the-imagio-opto-acoustic-breast-imaging-system-and-histologic-grade-of-breast-masses\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Data Presented at San Antonio Breast Cancer Symposium Confirms Correlation Between the Imagio\u2122 Opto-Acoustic Breast Imaging System and Histologic Grade of Breast Masses - Seno Medical\" \/>\n<meta property=\"og:description\" content=\"Additional Data Validates Potential of Imagio\u2122 Opto-Acoustic Breast Imaging System to Reduce Negative Biopsies NEWS PROVIDED BY Seno Medical Instruments, Inc. 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