Mammography misses about half the cancers in women with dense breasts, as dense tissue and cancer both appear white on mammogram images. Novi, MI-based Delphinus Medical Technologies wants to change the breast screening game with its 3D whole breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan.

The company just raised $30 million in a series D round to fuel commercialization of its SoftVue System. The closing of the round comes on the heels of the first SoftVue System being sold to Karmanos Cancer Institute in Detroit, MI, where the technology was originally conceived.

SoftVue has previously received three 510(k) clearances, and a pre-market application (PMA) approval for dense breast screening adjunct to mammography expands the company’s existing platform of approvals to include breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is BI-RADS c or d at the time of screening mammography. The device is not intended to be used as a replacement for screening mammography. SoftVue can be used at the same visit as screening mammography, and the SoftVue images are intended to be interpreted with the mammogram results to enhance screening.

“Every day it becomes increasingly obvious that we have delivered a game changer technology to transform dense breast screening,” said Mark J. Forchette, president and CEO at Delphinus Medical Technologies. “When potential customers hear that SoftVue finds more cancers, delivers an exceptional patient experience and efficient patient workflow the same day as the mammogram without costly staff additions, they recognize the value for their patients. Our series D will support the robust commercial strategies and efforts needed to help sites quickly adopt this solution for their patients.”

SoftVue was developed to provide a new annual breast screening solution for women with dense breast tissue, a historically underserved population. According to Delphinus, the technology enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography alone.

Delphinus was founded as a spin out of the Karmanos Cancer Institute and is capitalized through principal investments by Arboretum Ventures in Ann Arbor, MI., Beringea in Farmington Hills, MI, State of Michigan Retirement System, North Coast Technology Investors in Ann Arbor, MI, Venture Investors in Madison, WI, Hopen Life Science Ventures in Grand Rapids, MI, and Waycross Ventures in Menlo Park, CA.

“Our board of directors and investors are very excited to launch into commercial activities with SoftVue,” said Paul McCreadie, board chairman at Delphinus and chief operating officer at Arboretum Ventures. “The successful completion of a rigorous clinical study that resulted in the PMA approval we received last year for dense breast screening will allow the Delphinus team to leverage the unique technology of SoftVue to change the paradigm for dense breast screening and help millions of women receive superior care. We invest to allow breakthrough innovations to serve patients, and Delphinus is perfectly poised to do exactly that.”