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About Delphinus

Transforming Early Detection of Breast Cancer and Saving Lives

Our Mission

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.

Our History

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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

First SoftVue™ System Installed

2023

First SoftVue™ System is installed at Karmanos Cancer Institute

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