Seno Medical launches the CONFIDENCE registry study for Imagio®
San Antonio, TX, October 21, 2021 (GLOBE NEWSWIRE) – Texas-based Seno Medical Instruments, Inc. (Seno) has launched its CONFIDENCE registry to assess the effectiveness of opto-acoustic / ultrasound imaging (OA / US ) to diagnose breast abnormalities including cancer using its revolutionary ImagioÂ® Breast imaging system. About twelve sites will participate in the international registry, with a target of more than 600 total patients participating during the study period, ending in 2024.
Several international sites in the Netherlands are currently recruiting for the study. The aim of the study is to obtain real and post-market data on the use of the ImagioÂ® system and provide evidence of general use and performance of the system in a real environment.
“We believe that, just like other hybrid imaging modalities such as PET / CT, the sum of optoacoustics and ultrasound provides greater sensitivity and specificity than either. individual imaging modalities, âsaid Shaan Schaeffer, vice president of clinical operations at Seno.
The CONFIDENCE registry parameters to analyze include:
- Specificity, negative likelihood ratio, sensitivity and positive likelihood ratio for the ImagioÂ® System compared to other standard imaging modalities,
- Using ImagioÂ® System in relation to, and in combination with, other imaging modalities to influence the biopsy decision,
- Quality of life assessment – Morbidity index test,
- In malignant masses, evaluation of the roles of OA / US as a prognostic biomarker,
- Characteristics of the lesions / masses of the lymph nodes for which the device is used.
Breast biopsy procedures caused by false positive diagnostic evaluations in the United States cost the health care system more than $ 2 billion annually.I Imagio de SenoÂ® The technology could mitigate this with its non-invasive OA / US technology to help physicians better differentiate benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may or may not require more diagnostic evaluation. invasive.
Seno CEO Tom Umbel commented: âThis registry study will help us justify the effectiveness of ImagioÂ® The system in a real environment and the possibility for OA / US to benefit physicians and patients around the world.
The company’s OA / US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. Optoacoustic images provide a unique blood map in and around breast masses, while ultrasound provides a traditional anatomical image. By the appearance or absence of two characteristic indicators of cancer – angiogenesis and deoxygenation – Seno Medical has shown that ImagioÂ® The OA / US Breast Imaging System will be a more effective tool in helping radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to ionizing radiation (x-rays) or radiation. potentially harmful contrast agents. In addition to the new imagery provided by the ImagioÂ® System, Seno includes an artificial intelligence (AI) decision support tool (the SenoGramÂ®) to help physicians interpret the new images which, along with training and certification, help radiologists make the transition from ultrasound alone to OA / US imaging.
The system is indicated for use by trained and qualified healthcare providers to assess palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast exam following clinical presentation or breast cancer. ” other imaging tests such as a screening mammogram.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company engaged in the development and commercialization of a novel cancer diagnostic modality: optoacoustic imaging. Approved by the US FDA in January 2021, Imagio de Seno MedicalÂ® The breast imaging system merges opto-acoustic technology with ultrasound (OA / US) to generate functional and anatomical images of the breast in real time. To learn more about Seno Medical’s OA / US imaging technology and applications, visit www.SenoMedical.com.
I Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of use patterns and associated costs of breast imaging and diagnostic procedures after screening mammography. Clinico-economic results Res 2018; 10: 157-167.
Seno Medical launches the CONFIDENCE registry study for the ImagioÂ® breast imaging system