Healthcare Industry News:  ultrasound 

Devices Oncology

 News Release - November 25, 2013

Seno Medical Instruments Launches Pivotal Study of New Functional Imaging Platform in Breast Cancer Diagnosis

Study will determine safety and efficacy of Imagio™, an innovative opto-acoustic imaging system with potential to revolutionize cancer diagnosis

First 100 patients enrolled in Pivotal Study at 16 sites across the U.S.


SAN ANTONIO, Nov. 25, 2013 -- (Healthcare Sales & Marketing Network) -- Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the diagnosis of cancer, announced today that the first 100 patients have been enrolled into its Pivotal Study of Imagio™, a new opto-acoustic imaging system that may help women with benign breast masses avoid negative, invasive biopsies.

Each year in the U.S. 1.7 million[i] women undergo core needle or surgical breast biopsies after a suspicious mass is found through screening mammograms or self-exams and a series of diagnostic imaging tests are performed. However, four out of five of these biopsies reveal benign pathology[ii].

Imagio combines traditional ultrasound with an imaging technology based on light in and sound out called "opto-acoustics." 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.

"Although breast cancer is one of the most prevalent causes of death in women, the tools used to diagnose this disease have certain limitations that can make the process intrusive, costly and potentially harmful to patients," said Thomas Stavros, M.D., Medical Director, Seno Medical Instruments. "Breast biopsies, the current standard of care for diagnosing or ruling out cancer, are the most expensive part of the breast cancer diagnostic process. By providing a real-time blood map co-registered with ultrasound images, we believe that opto-acoustics can provide radiologists more information than ever before to help them confidently rule out cancer so that fewer women with benign lesions will have to undergo biopsies and the worry that can come from the process."

Because cancerous tumors grow relatively quickly, they require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio provides images of these networks and a map of oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio images depicting significant vascular structures and low oxygen levels are likely to indicate cancer.

The Imagio Pivotal Study will include 16 leading hospitals and imaging centers throughout the United States.

"Scanning the first 100 patients and starting the active enrollment phase is an important milestone for us in our mission to deliver a new standard in breast cancer diagnosis," said Janet Campbell, CEO of Seno Medical Instruments. "We believe Imagio can offer a better diagnostic alternative for women who have suspicious breast masses, and can help physicians more confidently rule out cancer with a less invasive test. Based on conversations with some of the top minds in radiology, we are encouraged that this new modality could have a significant impact of breast cancer diagnosis."

The American Cancer Society estimates that there were more than 2.9 million women with a history of invasive breast cancer living in the U.S. in 2012, with 226,870 of them diagnosed during the year.

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 standard 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 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.

[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

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