Prospective, controlled multi-center observational registry will include ~12 sites and 600 patients to collect data on opto-acoustic\/ultrasound (OA\/US) system.<\/i><\/p>\n
[SAN ANTONIO, TX \u2013 October 21, 2021] Texas-based Seno Medical Instruments, Inc. (Seno) has launched its CONFIDENCE registry to evaluate the efficacy of imaging with opto-acoustic\/ultrasound (OA\/US) to diagnose breast abnormalities including cancer using its groundbreaking Imagio\u00ae<\/sup>\u00a0Breast Imaging System.<\/p>\n Approximately twelve sites will participate in the international registry, with a target of over 600 total patients participating through the study\u2019s timeframe, ending in 2024.<\/p>\n Several international sites in the Netherlands are currently recruiting for the study. The study\u2019s intent is to obtain real-life, post-market data on the use of the Imagio\u00ae<\/sup>\u00a0System and to provide evidence on the general use and performance of the system in a real-world setting.<\/p>\n \u201cWe believe, much like other hybrid imaging modalities such as PET\/CT, the sum of opto-acoustics and ultrasound together provide greater sensitivity and specificity than either of the imaging modalities individually,\u201d says Shaan Schaeffer, VP of Clinical Operations at Seno.<\/p>\n CONFIDENCE registry endpoints to be analyzed include:<\/p>\n Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.[i] Seno\u2019s Imagio\u00ae<\/sup>\u00a0technology could mitigate that with its non-invasive OA\/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may\u2014or may not\u2014require more invasive diagnostic evaluation.<\/p>\n Seno\u2019s Chief Executive Officer, Tom Umbel, commented, \u201cThis registry study will help us substantiate the efficacy of the Imagio\u00ae<\/sup>\u00a0System in a real-world setting and the ability for OA\/US to benefit physicians and patients around the world.\u201d<\/p>\n The company\u2019s 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. Through the appearance or absence of two hallmark indicators of cancer \u2013 angiogenesis and deoxygenation \u2013 Seno Medical has shown that the Imagio\u00ae<\/sup>\u00a0OA\/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities \u2013 without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio\u00ae<\/sup>\u00a0System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram\u00ae<\/sup>) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA\/US imaging.<\/p>\n The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.<\/p>\n\n