Real World Use of OA Imaging Confirms Clinical Acceptability of Second Generation Imagio® Breast Imaging System

San Antonio, TX, Oct. 31, 2024 (GLOBE NEWSWIRE) — A study published in Academic Radiology, Exploring the Utility of Optoacoustic Imaging in Differentiation of Benign and Malignant Breast Masses: Gen 2 Study, confirms that the second generation of Seno Medical’s Imagio® Breast Imaging System, which combines light, sound, and artificial intelligence (AI), is equal to or superior to the company’s first-generation device.

The study, authored by Sammar Ghannam, MD, MPH, University Texas Health and Science Center Mays Cancer Center, San Antonio, TX – the first real-world use study of the second generation Imagio® System – assessed palpable and non-palpable breast abnormalities in 38 patients who required diagnostic breast ultrasound workups and confirmed the clinical acceptability of modifications made to the Imagio® System for its market-ready product as compared to its first-generation system.

The author observed that the Imagio®’s state-of-the-art ultrasound combined with Seno’s novel opto-acoustics imaging performed equal to or better than the first-generation device, with superior image quality and increased specificity without the loss of sensitivity. In this limited imaging study, using the SenoGram® AI decision support tool provided an observed 100 percent sensitivity and specificity at 64.3 percent. The combination of opto-acoustic imaging and AI provided by the Imagio® System helped distinguish masses, providing functional biologic data and imaging appearance in an efficient, effective, and cost-conscious manner. According to the authors, “The functional imaging of OA/US together with the DST (SenoGram®) does offer an objective and tightly calibrated method of predicting FNRs below 2.0% and even at and below 0.5%”.

“This is the first real world use study of the market-ready Imagio® Breast Imaging System and confirms that in day-to-day clinical practice, OA imaging is providing breast imagers with the diagnostic confidence they’ve been seeking,” commented Tom Umbel, CEO of Seno Medical. “Our technology allows for a simplified care pathway that improves patient care and helps reduce unnecessary exams and costs of diagnosing breast cancer.”

Opto-acoustic imaging is a category-defining technology that combines functional (opto-acoustics or photoacoustics), anatomic (ultrasound) and morphologic information using light (laser optics or opto-acoustics)  and sound waves plus proprietary artificial intelligence (SenoGram®) decision support to produce high-resolution, high- contrast images for clinicians. The result is a diagnostic imaging modality that delivers functional information regarding suspicious breast masses, increasing confidence regarding the need for invasive breast cancer diagnostic biopsies.

Imagio® is non-invasive, has no ionizing radiation, does not use contrast agents, and does not require the compression required in mammography. Imagio® provides clinicians with real-time information and the ability to provide same-day results. Incorporating Imagio® into a center can improve workflow efficiency and help lower stress and anxiety in patients.

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.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to improving the efficiency – and reducing the complexity – of breast cancer diagnostics through its new modality: opto-acoustic imaging. Approved by the U.S. FDA in January 2021, with supplemental approval in June 2022, Seno’s Imagio® Breast Imaging System is a new modality combining light, sound, and A.I. to provide information not previously available to the breast imager. The result is substantially improved confidence in diagnostic results that leads to real-time assessments, streamlined care pathways, and reductions in false- positive biopsies. The company was recognized by Frost & Sullivan with its 2023 Enabling Technology Leadership award for its innovative approach to diagnostic imaging. To learn more about Seno Medical’s imaging technology and applications, visit  www.SenoMedical.com.

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• Imagio® Breast Imaging System