|SoftVue breast cancer system--Courtesy of Delphinus|
It's difficult to detect potentially cancerous tumors in women with dense breast tissue via standard mammography--but that category includes almost two-thirds of U.S. women. The difficulty is so high, in fact, that almost half of states require women with dense breast tissue to be notified of that status.
Now, startup Delphinus Medical Technologies has raised $39.5 million to support a pivotal trial of its ultrasound breast cancer system, SoftVue. The system enables the imaging of the entire breast including the chest wall and is expected to be more effective at identifying tumors in dense breasts--without creating a high false positive rate.
"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," said Venture Investors Managing Director John Neis in a statement. His firm led the oversubscribed Series C round, with participation from new investors Hopen Life Science Ventures and Waycross Ventures along with existing investors Arboretum Ventures, Beringea, and North Coast Technology Investors.
"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," continued Neis on Delphinus. "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."
|Closeup of the SoftVue system--Courtesy of Delphinus|
The startup plans to conduct a large, multi-site clinical trial that's intended to back a PMA application for the use of SoftVue as a supplemental screen for women with dense breasts. The circular array transducer technology has already received FDA clearance as a diagnostic imaging tool not intended to replace mammography.
But first it will start a prospective study later this year that examines 10,000 women who have had SoftVue imaging at 8 U.S. centers. The trial will compare the technology to digital mammography in an attempt to demonstrate is effectiveness in detecting cancers as well as reducing false positives.
Patients lie flat on their stomach during SoftVue imaging, which is conducted in one to two minutes per breast and doesn't require breast compression as is typical with mammography.
Founded in 2010, Delphinus is a spinoff of the Karmanos Cancer Institute in Detroit, MI; the startup is based in nearby Plymouth, MI.
- here is the announcement
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