Delphinus Medical Technologies is a pioneering medical imaging company that developed the SoftVue 3D Whole Breast Tomography System, featuring the first circular array transducer technology. SoftVue is a radiation-free, no-compression, single-scan ultrasound tomography device intended to be used adjunctively with screening mammography for asymptomatic women with dense breast tissue and received FDA PMA approval in October 2021 for that indication. The company says SoftVue, when paired with screening mammography, can identify up to 20% more cancers while reducing false positives, unnecessary callbacks, and biopsies; dense breast tissue affects roughly 40% of women and can obscure cancers on mammograms. Delphinus continues to expand its commercial and clinical footprint, adding Corewell Health as a clinical site and installing systems at the University of Rochester Medical Center. The company was founded as a spin-out of the Karmanos Cancer Institute and is headquartered in Novi, Mich. Recent funding is intended to help scale operations and broaden the company’s impact on the global healthcare community. Delphinus Medical Technologies developed SoftVue, a 3D whole-breast ultrasound tomography system featuring a circular-array transducer that images the entire breast with a single scan. SoftVue exams use no radiation and require no compression, and the device is completed in a single scan. SoftVue has a PMA indication as an adjunct to digital mammography for asymptomatic women with dense breast tissue and is reported to identify up to 20% more cancers with greater accuracy and potentially fewer biopsies than FFDM alone. The exam can be performed at the same appointment as a screening mammogram, enabling a streamlined workflow and rapid delivery of results. Delphinus is headquartered in Novi, Mich., was founded as a spin-out of the Karmanos Cancer Institute, and has sold its first SoftVue system to the Karmanos Cancer Institute in Detroit. The company is pursuing worldwide commercialization of SoftVue to address the unmet clinical need in dense-breast screening. Delphinus Medical Technologies develops SoftVue, an automated whole-breast ultrasound system that uses a circular array transducer to image the entire breast without radiation or compression. SoftVue captures multi-dimensional, 360-degree cross-sectional ultrasound slices and has received sequential U.S. FDA clearances as a B-mode ultrasonic imaging system. The company positions SoftVue as a supplemental screening tool for women with dense breast tissue, aiming to detect cancers missed by mammography while reducing false positives. Delphinus plans a large multi-site clinical study prospectively imaging 10,000 women across eight centers to support a PMA application for a supplemental screening indication. The business is headquartered in Plymouth, Mich., with a satellite office in Sunnyvale, Calif. Its recent financing will fund regulatory efforts and commercialization of SoftVue. Delphinus Medical Technologies is a Michigan-based company and a 2009 spin-off of the Barbara Ann Karmanos Cancer Institute focused on commercializing the SoftVue whole breast ultrasound tomography system. SoftVue is a patented whole-breast ultrasound tomography imaging device that provides no radiation, no compression, and is not dependent on operator skill. The technology was invented by Peter Littrup, M.D., and Neb Duric, Ph.D., of Karmanos and Wayne State University, and the intellectual property was transferred to Delphinus via a worldwide license. Delphinus has filed for FDA clearance; SoftVue had not received market clearance at the time of the article. The company says SoftVue has potential to improve breast cancer diagnosis and plans future advancements beyond diagnosis to interventional techniques for biopsy and screening. The recent $11 million equity and debt financing will further development and support commercialization efforts upon clearance. Delphinus develops SoftVue, a tomographic ultrasound system and risk-assessment tool that uses multi-parametric ultrasound and computer algorithms to detect benign and malignant breast masses, including in dense tissue. The SoftVue technology was created and refined at the Karmanos Cancer Institute over about 10 years, and Karmanos currently holds the only prototype. The company secured $8M in venture capital to begin commercialization and to design and build the first 10 clinical machines. Proceeds will fund further clinical research to validate initial findings and pursue U.S. Food and Drug Administration approval. Management includes CEO William C. Greenway, CMO Peter Littrup, M.D., and CTO Neb Duric, Ph.D. Delphinus has also received grants from organizations including the Avon Foundation, NCI/NIH, Susan G. Komen, and state and private donors.

Total raised

$101M

Funding rounds

6

Latest round

Equity

Latest activity

Aug 2023