Data Show Seno Medical Instruments' Imagio® Could Potentially Allow Doctors to Eliminate the Need for a Breast Biopsy and Monitor Early Response to Treatment

VIENNA, March 10, 2014 /PRNewswire/ -- Seno Medical Instruments, Inc., the company pioneering development of opto-acoustic (OA) imaging as a tool to improve the process of diagnosing breast cancer, today announced that two analyses of outcomes from a U.S. Feasibility Study of its investigational Imagio® breast imaging device were presented at the annual meeting of the European Congress of Radiology 2014.

The first statistical analysis is of the Feasibility Study data (Abstract C-0926), suggests that information from Imagio may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound. This will be verified in the ongoing U.S. Pivotal Study which has already enrolled more than half of the 2,000 subject target.  Imagio may be a useful tool to help physicians reduce the need for biopsy in patients with benign but suspicious appearing breast masses on conventional diagnostic breast ultrasound.

"We are encouraged by these findings, which demonstrate the biopsy-sparing potential of Imagio," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. "While surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, biopsies are the most expensive part of the diagnostic process and over 80% of U.S. biopsies are negative. Imagio has the potential to contribute to the way that breast cancer is diagnosed and to optimize the decision to biopsy."

The second statistical analysis is of pre-defined histopathology findings relative to the specific features of benign and malignant lesions. This information was captured in the Imagio opto-acoustic images during the Feasibility Study. It suggests that Imagio may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman's diagnostic work-up, which will also be verified in the ongoing Pivotal Study.

Separate analysis of the feasibility data showed that OA findings could potentially correlate with molecular subtypes of breast cancer (Abstract C-1528). "If confirmed in a larger series of breast cancer patients, this analysis suggests that OA findings might be useful in differentiating and monitoring early response to medical oncologic treatments," said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. "Our ongoing Pivotal Study will continue to elucidate the potential Imagio may have in both classifying breast masses and determining molecular subtypes."

Imagio fuses an imaging technology based on light-in and sound-out called "opto-acoustics" with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn't expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

Each year in the U.S. 1.7 millionⁱ women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, more than 80% of these biopsies reveal benign pathologyⁱⁱ.

About the European Congress of Radiology (ECR)

The European Congress of Radiology (ECR) represents the medical specialty of radiology throughout Europe and the Mediterranean. The ECR comprises a Congress Committee, a Programme Planning Committee, and 17 Scientific Subcommittees. The next ECR congress will be held from March 5–9, 2015, in Vienna, Austria.

About SENO Medical Instruments,Inc.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno's Imagio™ breast imaging system uses opto-acoustic technology co-registered with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno's platform technology may also address other disease applications. To learn more about Seno Medical's opto-acoustic imaging technology and applications, visit www.SenoMedical.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd.
[email protected]
Tel: +1 917 497 2867

ⁱ Data provided by Thomson Reuters In-Patient and Out-Patient Views.

ⁱⁱ Silverstein MJ, et al. Image-Detected Breast Cancer: State of the Art Diagnosis and Treatment. Journal of the American College of Surgeons. 2005;201(4):586-597.

SOURCE Seno Medical Instruments, Inc.