Our Mission

Our mission is to tenaciously create and deliver medical innovations that will transform early detection of breast cancer and save women’s lives all over the world. Our passionate focus benefits patients and provides an inspiring and rewarding environment for employees to develop personally and professionally, and drives our company to thrive and grow.

 

 

Our Story

Headquartered in Novi, Michigan, Delphinus is the first company to design and manufacture a 3D whole breast ultrasound system that utilizes a dynamic new technique to image the breast with the use of sound and water.

Created by Peter Littrup, MD and Neb Duric, PhD, SoftVue™ features proprietary TriAD™ technology, measuring three critical sound characteristics through proprietary algorithms, advancing this technology far beyond traditional b-mode ultrasound.

Delphinus was formed in 2010 as a spin-out of the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan. Delphinus holds numerous patents and proprietary assets for its innovative and scientifically-advanced works and is poised to usher in a new era of breast imaging.

Our Guiding Values

  • Passion

    We are entrepreneurs, intensely devoted to our mission.

  • Innovation

    We are inventive, creative and deliver breakthrough technologies that save lives.

  • Teamwork

    We are one company, aligned with one vision. We work shoulder to shoulder in collaboration, fostering an environment of mutual respect and trust.

  • Character

    We are driven by our high integrity and core principles. We are transparent, tenacious and we ALWAYS do the right thing.

  • Hustle

    We execute with a sense of urgency and deliver results.

History of Delphinus

The Beginning

2010
Founded and headquartered in Plymouth, MI

First Investment

2010
Secured initial $8 million investment

Additional Funding

2013
Raised additional $11 million in funding

First FDA 510(k)

2013
Awarded first 510(k) clearance from FDA for SoftVue™

West Coast Office

2014
Additional office opened in Sunnyvale, CA in the heart of Silicon Valley

Second FDA 510(k)

2014
Gained 510(k) clearance from FDA for SoftVue™ for transmission color imaging

Record Investment

2015
Generated largest funding round in Michigan for a medical device company, over $39 million secured

New Home Base

2016
May, Headquarters relocated to Novi, MI, triples size of facility

Standout Design

2016
November, SoftVue™ reveal with new industrial design at RSNA

Training Milestone

2017
31 researchers trained for clinical project to recruit and image 10,000 women with SoftVue™

SoftVue Project Launch

2017
First patient in SoftVue™ clinical project enrolled

5000 Patients Enrolled

2018
In October, the 5000th patient was enrolled in the SoftVue™ clinical project

Pilot Reader Study

2018
Conducted pilot retrospective reader study to gauge the accuracy of SoftVue™ to guide future research and design

Third FDA 510(K)

2018
Received clearance for Breast interface assembly, sound speed image output, alternative reflection output, single crystal transducer and low frequency pulse

Second Pilot Reader Study Conducted

2019
32 Reader Pilot study to plan PMA to determine AUC1 improvement for SoftVue™ + Mammo compared to mammography alone

Retrospective Reader Study Conducted

2020
32 independent radiologists participated to determine AUC1 improvement for SoftVue™ + Mammo compared to mammography alone

PMA Submitted to FDA

2020
Results of the retrospective reader study demonstrate AUC improvement for SoftVue™+Mammo versus mammography

FDA PMA Approval

2021
FDA approved PMA for SoftVue™. Indicated for dense breast screening adjunct to digital mammography