SAN ANTONIO, Sept. 29, 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 it has completed the final phase of the company's U.S.-based PIONEER Pivotal Study of the Imagio® breast imaging system.

The PIONEER Study was designed to demonstrate that the Imagio breast imaging system can provide physicians with vital information they need to determine whether a suspicious breast mass is cancerous or not, helping women avoid negative biopsy procedures. Results from this study will serve as the basis for the company's Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).

Imagio was designed to identify the two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood. The technology is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities including magnetic resonance imaging (MRI) or positron emission tomography (PET).
"In light of the fact that a large majority of biopsies reveal benign pathology, we believe that Imagio could potentially help reduce the number of procedures generated by false positives by providing physicians with more information and thus be more confident in their imaging assessments," said Erin Neuschler, MD, Northwestern Medicine Radiologist, Assistant Professor of Radiology at theNorthwestern University Feinberg School of Medicine and the Co-Principal Investigator of the PIONEER Study. "Data from prior Seno studies demonstrated Imagio's potential to achieve clinically-meaningful diagnostic sensitivity and specificity for breast cancer beyond those delivered by traditional, diagnostic ultrasound. It is our hope and belief that the results of this study will confirm these earlier findings."

"We started doing basic research with opto-acoustics back in 2005 and it is noteworthy to see this rigorously conducted trial of this technology completed. We await the final analysis now that all of the patients have enrolled in the trial," said Stephen Grobmyer, MD, Director of Breast Services and principal investigator of the trial at Cleveland Clinic. "Based on our clinical experience to date, it appears this breast cancer imaging technology could enhance both the physician and the patient experience by reducing the number of the false positive cases, which we currently face assessing patients with abnormal breast imaging."

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