First Patient Enrolled in Pivotal Arm of the SoftVue Clinical Project

Pictured from left to right: Mark Forchette, Delphinus CEO, Mary Yamashita, MD, National Principal Investigator of the SoftVue Discover Breast Ultrasound Prospective Case Collection project, Shauna Lee, first patient, Linda Hovanessian Larsen, MD, Sub Investigator for the project and Edward G. Grant, MD, Chair and Professor of Radiology, USC

Delphinus Medical Technologies, Inc., is excited to announce the launch of the critical arm of the SoftVue™ Discover Breast Ultrasound Prospective Case Collection project and enrollment of the first patient at USC Keck School of Medicine. SoftVue is the world’s first three-dimensional, whole-breast ultrasound system that might better assist physicians in distinguishing normal breast tissue from cancers.
“While mammography is the best screening tool for women, we have known for years that breast cancers are much more difficult to see in women with dense breasts,” said Mary Yamashita, MD, Assistant Professor of Clinical Radiology and the National Principal Investigator of the research project. “Our hope is that this technology will enable us to detect cancers much sooner in women with dense breast tissue so that we can provide better outcome for those with cancer, and peace of mind for those with a negative study.”

“I was not sure what to expect, but the SoftVue™ exam was both easy and comfortable,” said Shauna Lee, the first patient enrolled in this arm of the clinical trial. She discovered she had dense breasts after an appointment with Dr. Yamashita, and was previously unfamiliar with the term. Lee was excited to enroll in the trial after learning that the technology was more comfortable and potentially more thorough than traditional mammography.

The project will enroll 10,000 asymptomatic women with dense breast tissue at several centers in the U.S. More than 40 percent  of women nationwide have dense breast tissue, which is unrelated to weight or breast size. Because dense breasts can mask potential cancers on mammography, the sensitivity for detecting cancer is lower in women with dense breasts. Studies have shown that in dense breasts, ultrasound can detect cancers not seen on mammography. However, traditional handheld ultrasound exams can be time consuming and often operator dependent. They also have a high rate of false positives, resulting in unnecessary biopsies and added cost to the healthcare system.

In contrast, SoftVue™ is a fast, fully automated, and gentle system that conducts scans while a woman relaxes on her stomach with her breast supported in a warm water bath. A 360-degree ring transducer images the entire breast in a single pass, moving from the front of the breast to the chest wall.  The entire scan only takes about 2-4 minutes per breast and there is no radiation exposure or compression of the breast.  Unlike handheld ultrasound, SoftVue™ can provide multiple distinctive tissue qualities to radiologists, allowing them to differentiate possible cancers from normal to benign findings.  

“I am hopeful that this ultrasound could be the new standard of care for women with dense breasts, and I would encourage other women who qualify to enroll in this trial,” said Lee.

Delphinus President and CEO Mark J. Forchette added, “Our company’s singular focus is to transform early detection of breast cancer with our breakthrough SoftVue imaging technology. We are excited to launch the Discover Breast Ultrasound project, working with leading radiologists and breast cancer specialists to demonstrate the value of our novel whole breast ultrasound technology, and its ability to improve early detection of breast cancer combined with mammography.”

Qualified participants in this project will have both screening mammography and SoftVue™ exams. Imaging information gathered from the project will compare SoftVue™ to digital mammography, and measure the effectiveness of SoftVue™ in detecting additional cancers that are not seen with mammography alone.

The study data will be submitted to the U.S. Food and Drug Administration for approval of SoftVue™ as a supplemental screening indication for women with dense breasts in combination with mammography.  SoftVue™ has received two 510(k) clearances from the FDA for diagnostic breast ultrasound imaging and is not intended for use as a replacement for screening mammography.  Currently, the technology is only in use at participating sites.

 

[1] Sprague BL, et al. Prevalence of Mammographically Dense Breasts in the United States. J Natl Cancer Inst. 2014 Oct; 106(10): dju255. Published online 2014 Sep 12.