PLYMOUTH TOWNSHIP, Mich.–(BUSINESS WIRE)–Delphinus
Medical Technologies, Inc., the leader in advanced breast ultrasound
technology, announced today that it has appointed Francis X. Dobscha as
its new vice president of quality and regulatory affairs. With more than
30 years of experience in healthcare, Dobscha will lead the
organization’s quality efforts and guide the regulatory submissions as
the company continues clinical studies of its SoftVue™ technology. SoftVue
is a breakthrough whole breast ultrasound system that allows physicians
to image the entire breast for diagnostic imaging purposes.
“The wealth of knowledge Francis has in regulatory affairs, as well as
quality and compliance systems, will be invaluable as we continue to
study SoftVue and the value it brings to detecting breast cancer in
women with dense breasts as a supplement to mammography,” said Mark J.
Forchette, president and CEO of Delphinus. “His depth of experience will
also be instrumental as we build toward commercialization.”
Dobscha has provided international regulatory and quality compliance for
a range of medical device companies, including DePuy-Synthes (a Johnson
& Johnson company), Covidien, NOMOS Corporation, Respironics, Inc. and
Medrad, Inc. He has also served as the director of technology and
regulatory affairs at AdvaMed, the world’s largest trade organization
representing the medical technology industry.
“I look forward to helping ensure that women with dense breast tissue
are able to take advantage of SoftVue’s cutting-edge diagnostic
technology,” Dobscha said. “Joining an organization such as Delphinus
that is bringing significant improvements to healthcare is a
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. The technology is currently cleared
by the U.S. Food and Drug Administration for diagnostic imaging purposes
and is not intended for use as a replacement for screening mammography.
Dobscha will be instrumental in guiding a large multi-site clinical
study that Delphinus is planning in support of a PMA application for a
supplemental screening indication for women with dense breasts. Next
year, the company will begin imaging 10,000 women with SoftVue in eight
centers around the country. From these imaging sets, a reader study will
then be conducted for submission to the FDA. 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.
Dobscha is a member of the Regulatory Affairs Professionals Society, the
American Society for Quality, Rocky Mountain Regulatory Affairs Society,
Colorado BioScience Association, as well as AdvaMed, where he has served
on multiple committees. He received his Bachelor of Science in technical
writing and editing from Carnegie-Mellon University in Pittsburgh,
Penn., and his Master of Business Administration from Katz Graduate
School of Business at the University of Pittsburgh.
About Delphinus Medical Technologies, Inc.
in Plymouth, Mich. with a satellite office in Sunnyvale,
Calif., Delphinus Medical Technologies, Inc. is a pioneering medical
imaging company that has developed SoftVue™, the first circular array
transducer technology that has received sequential U.S. Food and Drug
Administration clearances. The patented technology is a whole breast
ultrasound imaging device that delivers no radiation, requires no
compression, and images the entire breast with a single scan. SoftVue is
indicated for use as a B-mode ultrasonic imaging system and is not
intended to be used as a replacement for screening mammography.
Delphinus was founded as a spin out of the Karmanos Cancer Institute in
Detroit and is capitalized through principal investments by Arboretum
Ventures, Ann Arbor, Mich., Beringea, Farmington Hills, Mich., North
Coast Technology Investors, Ann Arbor, Mich., Venture Investors,
Madison, Wis., Hopen Life Science Ventures, Grand Rapids, Mich., and
Waycross Ventures, Menlo Park, Calif. For more information, visit www.delphinusmt.com.
Nobles Global Communications
Diana Soltesz, 818-618-5634