PLYMOUTH
TWP. – The ultrasound-based breast imaging technology developer Delphinus
Medical Technologies Inc. says it has secured $39.5 million in new series C venture
capital round – what the company contends is the single largest amount ever
raised for a healthcare imaging company in the Midwest, as well as the largest
for a medical device company in Michigan.
The
oversubscribed financing round will be used to underwrite regulatory costs,
continuing the commercialization of SoftVue, Delphinus’ whole-breast ultrasound
system that allows doctors to image the entire breast, including the chest
wall, for diagnostic purposes.
“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 John Neis, managing director at Venture 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.
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.”
Currently,
24 states have enacted legislation requiring that women who have dense breast
tissue receive notification of it in their mammography report. The legislation
covers nearly two-thirds of the women in the United States. Dense breast tissue
increases a woman’s chance of having breast cancer, yet presents a greater
challenge in detecting it with mammography alone. Supplemental breast imaging,
such as breast ultrasound, may benefit women with dense breast tissue.
As an
ultrasound technology, SoftVue offers the potential to not only assist
physicians in finding more cancers, but also to reduce the false positive rates
that have troubled other breast imaging techniques. SoftVue’s unparalleled,
sophisticated design incorporates a circular ultrasound transducer, unique to
medical imaging, presenting cross-sectional ultrasound slices through the
entire volume of breast tissue. The multi-dimensional imaging captures not only
reflected echoes in a 360-degree array, but also signals passing through the
breast, depicting tissue characterization.
“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,” said Mark J. Forchette, president and CEO of Delphinus. “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.”
The round
was led by the Milwaukee-based venture capital firm Venture Investors LLC, and
included new investment from Grand Rapids-based Hopen Life Science Ventures and
Menlo Park, Calif.-based Waycross Ventures, along with current investors
Arboretum Ventures of Ann Arbor, Beringea of Farmington Hills, and North Coast
Technology Investors of Ann Arbor.
Delphinus is
planning to launch a large multi-site clinical study to support a PMA
application for a supplemental screening indication for women with dense
breasts. Later this year, the company will begin by prospectively imaging
10,000 women with SoftVue in eight centers around the country. Using the
imaging, a reader study will then be conducted. The study will compare SoftVue
to digital mammography, and demonstrate its effectiveness in finding cancers
that are not seen with mammography, while reducing false positives, thereby
reducing the need for follow-up testing. False positives have gained recent
attention in other breast imaging technologies and have been implicated in
driving up healthcare costs, as well as patient anxiety.
More athttp://www.delphinusmt.com.
