Devices & Diagnostics, Startups

Delphinus raises $39.5M for whole breast ultrasound

Michigan startup Delphinus Medical Technologies just raised $39.5 million – the largest medtech fundraise in the Midwest – for its whole breast ultrasound device. It’s chasing FDA approval after a study next year of 10,000 women with dense breast tissue.

Michigan-based breast ultrasound developer Delphinus Medical Technologies just closed out a $39.5 million Series C round – what investors say is the Midwest’s largest medical device fundraise.

The company is developing a whole breast ultrasound system, called SoftVue, that lets doctors image the entire breast and chest wall for diagnostic purposes. Its multi-dimensional imaging shows a cross-sectional view of the full breast.

The dollars will help Delphinus navigate the regulatory pathway to achieve approval as a primary breast cancer diagnostic, as well as fund trials next year for 10,000 women with dense breast tissue in eight centers around the country. The device has had Food and Drug Administration approval since January 2014 for use as a follow-on diagnostic for breast cancer.

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Whole breast ultrasound could serve as an improvement over standard mammography techniques because it could lower the rate of false positive diagnoses, the company asserts. False positives are particularly prevalent among women with dense breast tissue.

“Dense breast tissue increases a woman’s chance of having breast cancer, yet presents a greater challenge in detecting it with mammography alone,” the company says. “Supplemental breast imaging, such as breast ultrasound, may benefit women with dense breast tissue.”

The round was led by Venture Investors, but included funding from Hopen Life Science Ventures, Waycross Ventures, Arboretum Ventures, Beringea, and North Coast Technology Investors.

Image courtesy of Delphinus Medical Technologies