The Barbara Ann Karmanos Cancer Institute, the Detroit-based National Cancer Institute-Designated Comprehensive Cancer Center, is the first to receive the SoftVue 3D Whole Breast Ultrasound Tomography System (SoftVue), following its approval by the U.S. FDA. Developed by Novi-based Delphinus Medical Technologies, the new technology was designed to be the screening solution for women with dense breast tissue.

Dense breast tissue is common, affecting 40% of women and making them four times more likely to develop breast cancer. Compounding the increased risk, dense breast tissue typically appears as a solid white area on a mammogram, making it difficult to distinguish from masses and other serious abnormalities, missing roughly half of new cancer cases.

When paired with a screening mammogram, SoftVue has been shown to identify up to 20% more cancers, while also reducing false positives and decreasing unnecessary call-backs and biopsies, company officials say.

“As a leading cancer center, we are committed to providing our patients with superior diagnostic and screening technology. The development of SoftVue, in partnership with Delphinus Medical Technologies, will further strengthen our fight against breast cancer that accounts for one in three new cancer diagnoses in women each year,” says Brian Gamble, president of the Karmanos Cancer Hospital.

“The key to breast cancer survival is early detection and this new screening device will be lifesaving for so many women in our community. Our clinical team worked hard for many years to develop this transformational technology, and we are proud to be the first in the world to offer SoftVue to our patients,” Gamble adds.

Dedicated to the mission of leading in transformative cancer care, research, and education, in 2009, Karmanos launched Delphinus Medical Technologies. The two organizations have since worked on various prototypes and conducted dozens of clinical trials to develop the technology, demonstrating its ability to detect the presence of malignant and benign masses in women with dense breasts safely and more accurately.

SoftVue, used as an adjunct to mammography, allows women with dense breast tissue to have both cancer screenings during a single appointment. Taking approximately eight to 10 minutes, a SoftVue mammogram uses warm water and ultrasound technology to create a 3D image of the whole breast to detect the presence of cancer in its earliest stages—including masses in dense breast tissue often missed by mammography alone—while avoiding radiation exposure and compression, allowing the radiologist to make a more accurate diagnosis.

“The team at Karmanos has contributed deeply to the creation of our breakthrough SoftVue™ ultrasound tomography system, and we are thrilled to announce that they placed the first order and will be the first in the world to offer SoftVue,” says Mark Forchette, president and CEO of Delphinus Medical Technologies, Inc. “We are excited about our next steps together to provide a new solution for the unmet needs and challenges of dense breast screening, and to share our proven clinical benefits with their patients.”

The SoftVue System will be available to patients at Karmanos Cancer Institute before the end of the year.