Opto-Acoustic Breast Imaging System Could Reduce Negative Biopsies

Seno Medical Instruments Inc., 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, M.D., Ph.D., 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.”
 
There are over 1.6 million biopsies performed annually¹ and recent reported data noted an 81 percent “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 percent. 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 percent of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5 percent of cases. The interim results also showed that Imagio OA also increased specificity to over 43 percent, with no significant loss in sensitivity. Importantly, clinicians were able to reduce the rate of false-positive diagnoses by 20 percent for the last 48 subjects evaluated in the study.
 
“The interim results of the MAESTRO study are promising and could help physicians reliably and safely assess suspicious masses to deliver optimal treatment for each patient,” said Tom Umbel, CEO of Seno Medical Instruments. “We look forward to the delivery of the first Imagio OA/US systems in the Netherlands, UK and Germany early next year.”
 
Final results from the MAESTRO study are expected to be announced in early 2017. Enrollment for a U.S. trial of more than 2,000 patients has been completed and results will be announced in the latter half of 2017.
 
Seno Medical’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. The 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 radioisotopes to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.