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Seno Medical's market-ready Imagio OA/US breast imaging system receives supplemental FDA PMA approval

Press releases may be edited for formatting or style | June 28, 2022 Women's Health
[SAN ANTONIO, TX – June 28, 2022] Seno Medical's Imagio® Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA). Seno's market-ready, groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation.

The Imagio® Breast Imaging System incorporates state-of-the-art ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio® more ergonomic and truly disruptive for the marketplace with the latest technological advances.

Tom Umbel, President and CEO of Seno Medical, commented, "This team is passionately committed to providing a revolutionary leap forward in patient care, and our commercial version of our Imagio® System delivers just that. With our novel OA/US platform, combined with the latest technologies available today in breast imaging, we are delivering a new hybrid modality that will help providers deliver the best care possible to their patients."

The company is launching a mobile education and demonstration tour, Imagio® OA/US Road Show - Scans Across America, to enable on-site, hands-on demonstration with the Imagio® System throughout the United States. The Imagio® OA/US Road Show - Scans Across America tour will begin in late July with continued stops across the country throughout 2022.

Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.[i] Seno's Imagio® technology could significantly reduce those costs with its non-invasive OA/US innovation.

Seno's OA/US system 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 — angiogenesis and hypoxia — Seno Medical has shown that the Imagio® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram®) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.

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 developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical's Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical's OA/US imaging technology and applications, visit www.SenoMedical.com.

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