SAN ANTONIO, Sept. 24, 2016 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno Medical), the company pioneering the development of opto-acoustic technology as a tool to improve the process of diagnosing breast cancer, announced today interim results from the company's multicenter, European MAESTRO post-market surveillance and clinical follow-up study. The results demonstrate the potential of its Imagio® opto-acoustic (OA) breast imaging system to provide physicians with vital information needed to determine whether or not a suspicious mass is cancerous, with the goal of reducing the rate of negative biopsies. The data were presented at a clinical symposium at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world dedicated to breast cancer imaging, on September 24, 2016 in Paris.
"The interim results from MAESTRO add to the growing body of clinical evidence showing that the Imagio opto-acoustic diagnostic tool increases physicians' confidence when differentiating and classifying malignant and benign breast tissue," said the study's principal investigator Ruud Pijnappel, MD, PhD, Radiologist, University Medical Center, Utrecht, NL, who presented the interim analysis. "The improved accuracy that is possible with this technology could help women avoid painful biopsy procedures that sometimes follow false-positive diagnoses."
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There are over 1.6 million biopsies performed annually1 and recent reported data noted an 81% "false positive" rate of biopsy procedures – the portion of biopsies that do not lead to breast cancer surgery.2 Seno Medical's Imagio breast imaging system, which received its CE Mark in 2014, has the potential to reduce negative biopsies by 43%. Seno Medical is targeting their PMA submission for the Imagio system to the U.S Food and Drug Administration by the end of 2016.
MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of Opto-Acoustics to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study.
The interim analysis of 78 subjects found that following the use of Imagio system, radiologists downgraded BI-RADS categories of the internal ultrasound control-classified BI-RADS 4a masses to BI-RADS 3 or 2 in 75% of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5% of cases. The interim results also showed that Imagio OA also increased specificity to over 43%, with no significant loss in sensitivity. Importantly, clinicians were able to reduce the rate of false-positive diagnoses by 20% for the last 48 subjects evaluated in the study.