Seno Medical Instruments today released data from 2 new analyses of a post-market study of its Imagio opto-acoustic technology designed to aid in the diagnosis of breast cancer, hoping to submit a Premarket Approval application to the FDA early next year.
The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive biopsies.
Data from the analyses were presented at the 2016 San Antonio Beast Cancer Symposium.
“These studies are an important step forward in the development of noninvasive breast imaging technology. Evaluation of the Imagio system significantly included an independent analysis of the patient’s pathology, unparalleled in the pre-release development of any breast imaging technology. The findings indicate the Imagio system can provide an accurate and noninvasive differentiation of benign from cancerous breast masses and will be an important means of reducing the number of benign breast biopsies,” Pioneer study pathologist Dr. F. Tucker said in prepared remarks.
The Maestro study enrolled 200 patients, and was designed to explore the diagnostic value of opto-acoustic imaging compared to conventional diagnostic ultrasound in suspicious masses classified as BI-RADS 4a and 4b.
The 1st analysis of the study examined the correlation between opto-acoustic imaging results and histologic data of breast masses, and reported a statistically significant correlation between opto-acoustic breast imaging results and those based on histopathologic analysis.
A 2nd interim analysis examined opto-acoustic downclassification and upclassification data, and reported that the Imagio system improved physicians’ ability to accurately classify breast masses as malignant or benign when compared to traditional ultrasound.
“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. We believe the final results of the Maestro study to be presented in 2017 will confirm these interim results,” LRBC CEO Dr. Ruud Pijnappel said in a prepared statement.
The company said it plans to announce final results from the Maestro study in early 2017, while results from its 2,000-patient Pioneer study are expected to be released in the 2nd half of 2017.
Seno Medical said it hopes for a PMA submission to the FDA in early 2017, following the study releases.
“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. 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,” CEO Tom Umbel said in a press release.
Last December, Seno Medical released data from the pilot study portion of its Pioneer pivotal study.
The company said data from the trial showed Imagio system improved physicians’ ability to classify benign breast masses when compared to traditional ultrasounds methods.
In the pilot study, independent specialists assessed 102 masses using the Imagio OA images, and were able to downgrade conventional diagnostic ultrasound findings of BR3 masses to BR2 masses in 33% of cases, BR4a masses to BR2 or 3 masses in 53% of cases and BR 4b masses to BR 3 or 2 masses in 33% of cases.
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