Delphinus Medical Technologies said today that it raised a $39.5 million Series C round led by Venture Investors for its SoftVue whole breast ultrasound system.
Proceeds from the round, which was joined by new investors Hopen Life Science Ventures and Waycross Ventures and existing backers Arboretum Ventures, Beringea, and North Coast Technology Investors, are slated for regulatory and commercialization expenses as Plymouth Township, Mich.-based Delphinus looks to get SoftVue on the market.
Delphinus said the SoftVue device uses a unique, circular ultrasound transducer to create cross-sectional ultrasound slices of the entire volume of breast tissue and distinguish potential tumors in dense breast tissue.
President & CEO Mark Forchette told MassDevice.com today that SoftVue is different from competing breast imaging devices from GE Healthcare and Siemens because of its “through transmission.”
“We not only capture reflection imaging, we also capture sound speed and attenuation,” Forchette explained. “That lets us not only see masses in dense breast tissue, but to assess their character. There’s no other system in the marketplace that does that.”
The company is planning a large study to back a pre-market approval application with the FDA, seeking a supplemental screening indication for women with dense breasts. The trial will compare SoftVue imaging with digital mammography in 10,000 women at 8 centers, beginning later this year, Delphinus said.
In the meantime, Delphinus plans to begin commercializing in the U.S. under a pair of 510(k) clearances earned from the FDA in 2013 and 2014, Forchette said.
“Our Series C financing demonstrates the confidence that sophisticated medical device investors have in our SoftVue automated whole breast ultrasound technology, and its potential to serve women with a transformational approach to breast imaging,” president & CEO Mark Forchette said in prepared remarks. “This syndicate of investors combines the robust strength of the Midwest venture capital community with investors in Silicon Valley to provide diverse support for our breakthrough system, which was invented right here in Michigan.”
“Delphinus has the potential to have a profound impact on the effectiveness of breast cancer screening for a significant population of women who have dense breasts,” added Venture Investors managing director John Neis. “Data from their innovative approach demonstrate the potential to detect cancers in women with dense breast tissue that are missed by mammography, without the unacceptable false positive rate that has plagued prior attempts using screening ultrasound. They have assembled a world-class team, and we are proud to help pull together this strong investor syndicate, giving them the resources to complete the necessary clinical studies and bring this life-saving tool to the market.”