SAN ANTONIO, Oct. 27, 2015 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno), the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, announced today the presentation of case reports from the company's European MAESTRO Study, demonstrating the potential of its Imagio® opto-acoustic (OA) breast imaging system to provide physicians with vital information needed to determine whether a suspicious breast mass is cancerous or not, helping women avoid negative biopsy procedures. The data was presented at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world that is dedicated to breast cancer imaging, on October 3, 2015 in London.
"The Imagio system potentially arms physicians with an improved diagnostic tool to help us classify benign masses in breast tissue," said Carla Meeuwis, MD, PhD, Radiologist at Rijnstate Hospital, who co-presented the results with Jeroen Veltman, MD, PhD, Radiologist at ZGT, Hengelo, as part of a symposium sponsored by Seno. "Greater diagnostic accuracy potentially achieved with this technology could help people avoid unnecessary biopsy procedures that result from false-positive diagnoses."
MAESTRO is a controlled, multi-center, observational, post-market surveillance study designed to evaluate if the Imagio imaging system can downgrade BI-RADS (Breast Imaging-Reporting and Data System) classification following conventional diagnostic ultrasound (CDU) for the visualization and characterization of suspicious masses prior to core needle biopsy (CNB) or excision. Investigators performed CDU to reach a diagnosis and decision to biopsy and then underwent an Imagio OA examination. All enrolled patients are females who are 18 years old or older and have undiagnosed suspicious masses.
"The MAESTRO results may help demonstrate the Imagio system's potential ability to both downgrade and upgrade breast masses. This is promising in our hopes to provide greater confidence to physicians when assessing suspicious masses based on imaging information," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno, who also presented results from a 100-subject pilot study, conducted as a part of Seno's larger Pivotal PIONEER Study in the U.S.
Ritse Mann, MD, PhD, Radiologist at Radboud University Nijmegen Medical Centre also presented case reports from the MAESTRO study. In his presentation, "Opto-acoustics as a potential new diagnostic technology in breast care: Practical experiences from the field," Dr. Mann discussed the benefits of the Imagio device and experiences from the MAESTRO Study, including key findings such as Imagio's potential ability to diagnose small masses, decrease false positives, and minimize false negatives.
"The Imagio is a reliable and safe real time technology that allows us to perform the examination and interpret the patient's results quickly," said Dr. Mann. "It is comfortable for patients to undergo and can potentially provide the vital information we need to help us improve the lives of patients with suspicious breast masses."
The EUSOBI conference consisted of plenary lectures, workshops, symposia, poster sessions and technical exhibitions. The conference attracted renowned international speakers who shared their latest information and perspectives on emerging technologies in the breast cancer imaging space.
Seno's Imagio co-registers and fuses opto-acoustics, a technology based on "light-in and sound-out," with diagnostic ultrasound. 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 provides real-time images of these networks and a map of relative oxygen-rich or oxygen-deprived 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.
According to the American Cancer Society, an estimated 231,840 new cases of invasive breast cancer, along with 60,290 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2015. An estimated 40,290 women in the U.S. are expected to die in 2015 from breast cancer. Only lung cancer accounts for more cancer deaths in women.
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 blood map 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 www.SenoMedical.com
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SOURCE Seno Medical Instruments, Inc.