First Patient Enrolled in Clinical Project Comparing SoftVue and Mammography in Dense Breast Tissue

Delphinus Medical Technologies Inc., developer of advanced breast ultrasound technology, has launched the SoftVue Discover Breast Ultrasound Prospective Case Collection project, enrolling the first patient.
 
Qualified participants will undergo screening digital mammography as well as SoftVue 3D whole breast ultrasound exams. Information gathered from the project will compare SoftVue imaging to digital mammography to determine the effectiveness of detecting additional cancers with SoftVue that are not seen with mammography alone, particularly in women with dense breast tissue.
 
The project will enroll 10,000 asymptomatic women with dense breast tissue at several centers in the United States. More than 40 percent¹ 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 lies on her stomach on a padded table, 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 takes about two to four 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.
 
“Dense breast tissue can mask or hide cancer, making it more difficult for mammography to detect cancer. And while ultrasound has been shown to be effective in detecting cancer in dense breasts, there’s a need for advanced technology like SoftVue that enables fast and comfortable whole breast ultrasound with fewer false positives,” said Mary Yamashita, M.D., assistant professor of clinical radiology at USC Norris Comprehensive Cancer Center and the national principal investigator of the Discover Breast Ultrasound project. “This important research will help us confirm the efficacy of the SoftVue system and potentially help establish new standards of care in dense breast tissue cancer screening.”
 
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.”
 
The Discover Breast Ultrasound project is recruiting participants at centers that include: USC Norris Comprehensive Cancer Center; Mt. Sinai Medical Center; Beaumont Hospital – Dearborn; Elizabeth Wende Breast Care; Southcoast Health Imaging; St. Elizabeth Hospital, part of Ascension; and Weinstein Imaging. Data from this study will support the company’s submission of a PMA application to the U.S. Food and Drug Administration (FDA) for a supplemental screening indication for women with dense breasts in combination with mammography. SoftVue has already 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.
 
Headquartered in Novi, Mich., Delphinus Medical Technologies is a medical imaging company that has developed SoftVue, the first circular array transducer technology that has received sequential FDA clearances. The patented technology is a 3D whole breast ultrasound imaging device that delivers no radiation, requires no compression, and images the entire breast with a single scan. SoftVue is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for screening mammography. Delphinus was founded as a spin out of the Karmanos Cancer Institute in Detroit, Mich., and is capitalized through principal investments by Arboretum Ventures of Ann Arbor, Mich.; Beringea of Farmington Hills, Mich.; North Coast Technology Investors of Ann Arbor; Venture Investors of Madison, Wis.; Hopen Life Science Ventures of Grand Rapids, Mich.; and Waycross Ventures of Menlo Park, Calif.
 
SoftVue™ is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for screening mammography.

Reference      
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.