Seno completes PIONEER Pivotal Study of non-invasive Imagio breast imaging system

Oct 1 2015

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."

The PIONEER Study was conducted in 16 leading institutions throughout the U.S., with more than 2,100 subjects enrolled. The study was designed to measure the sensitivity and specificity of Imagio compared to grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects underwent a traditional ultrasound and an Imagio scan. The radiologist used clinical mammography and traditional ultrasound findings to determine if the subject should advance to the biopsy phase. The Imagio results were later interpreted by an independent reader panel. Subjects who were put into follow-up were re-evaluated 12 months after their initial examination to confirm the results as a true negative.

"We are pleased to have completed the final phase for the PIONEER Study. I would like to thank our sites and readers for their commitment to this important milestone," said Tom Miller, CEO of Seno Medical Instruments. "This represents an important achievement in Seno's mission to help improve the diagnostic process for breast cancer. This product shows promise for improving the diagnosis of suspicious breast lesions in hundreds of thousands of women across the U.S."

After the interim analysis of the PIONEER Study, Seno initiated a separate European Post Marketing and Clinical Follow-up Study, the MAESTRO Study. The company currently has five sites participating in this study in the Netherlands.

Results from the MAESTRO Study will be presented at the upcoming 2015 European Society of Breast Imaging Annual Scientific Meeting (EUSOBI), the second largest conference dedicated to breast cancer imaging. The EUSOBI meeting will take place on October 2–3 in London. The results of the PIONEER Pilot Study will be presented at the Radiological Society of North America Annual Meeting (RSNA), the premiere conference in the world for radiology, from November 29 – December 4 in Chicago, Illinois.

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.

"Despite breast cancer being one of the leading causes of death in women, physicians are still quite limited by the diagnostic tools currently available," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno Medical Instruments. "The opto-acoustics technology utilized by Imagio is a potential solution in providing clinicians with a less invasive method to rule out cancer, which could help improve both the patient/physician experience and economic outcomes."

Seno's Imagio 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.