"The 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," said Ruud Pijnappel MD, PhD, Professor Breast Radiology at UMC Utrecht, Netherlands and CEO of LRBC - Dutch Reference Centre for Screening. "We believe the final results of the MAESTRO study to be presented in 2017 will confirm these interim results."

"Together, 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," said Tom Umbel, CEO of Seno Medical Instruments. "We 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 – PIONEER – in 2017."


Seno Medical Instruments expects to announce the final results from the MAESTRO study in early 2017. Results from the company's 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.

Seno's Imagio system co-registers and fuses opto-acoustics, a technology based on "light-in and sound-out," with diagnostic ultrasound - (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 provides real-time images of these networks and a map of relative oxygen-rich or oxygen-depleted 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's exposure to any potentially harmful aspects of imaging.


About Seno Medical Instruments, Inc.
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's 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 – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno's 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's opto-acoustic imaging technology and applications, visit http://www.SenoMedical.com

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