Michael Barbella, Managing Editor10.25.23
Delphinus Medical Technologies has raised $12 million in growth capital from Trinity Capital Inc., a provider of diversified financial solutions to growth-stage companies.
Delphinus’ transformational SoftVue 3D Whole Breast Tomography System was approved by the U.S. Food & Drug Administration (FDA) in October 2021 as an adjunct to digital mammography in screening asymptomatic women with dense breast tissue. This technology not only redefines the standards for early breast cancer detection, but also enhances patient comfort, and reduces unnecessary callbacks.
Dense breast tissue is common, affecting 40% of women, and making them four to six times more likely to develop breast cancer. Compounding this increased risk, dense breast tissue appears white on mammograms, as do cancerous masses, causing clinicians to miss roughly half of new cancer cases in this population of women. When paired with screening mammography, SoftVue has been shown to identify up to 20% more cancers, while also reducing false positives and decreasing unnecessary call-backs and biopsies.
“Mammography alone is not enough to address the screening needs of dense breast patients,” Delphinus Medical Technologies President/CEO Mark J. Forchette said. “SoftVue provides a solution that enables providers to transform their patients’ clinical experience. Our relationship with Trinity Capital helps us make impactful investments in execution, to help our clinical partners embrace this innovation, and serve the unmet needs of patients with dense breast tissue that SoftVue was designed to address.”
The Trinity funding enables the Delphinus team to continue to scale operations, broadening its impact on the global healthcare community. Delphinus continues to expand its commercial foundation, most recently adding Corewell Health to the roster of clinical sites that are building robust dense breast screening programs to benefit patients. Earlier this year, Delphinus announced the expansion of its list of commercial and research partners with a new installation at The University of Rochester Medical Center.
“We are excited to be a part of Delphinus’ journey as they innovate life-saving medical imaging technology,” said Lauren Cosentino, managing director, life sciences, at Trinity. “We believe in their team and are excited to help accelerate their growth trajectory.”
SoftVue has previously received three FDA 510(k)s, and PMA approval for dense breast screening adjunct to mammography expands the company’s existing platform of approvals to include breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is BI-RADS c or d at the time of screening mammography. The device is not intended to be used as a replacement for screening mammography. SoftVue can be used at the same visit as screening mammography, and the SoftVue images are intended to be interpreted with the mammogram results to enhance screening.
Trinity Capital Inc., an internally managed business development company, provides diversified financial solutions to growth-stage companies with institutional equity investors. Trinity Capital's investment objective is to generate current income and, to a lesser extent, capital appreciation through investments, including term loans and equipment financings and equity-related investments.
Headquartered in Novi, Mich., Delphinus Medical Technologies Inc. has developed SoftVue, featuring the first circular array transducer technology. The patented technology is a 3D whole breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan. Delphinus was founded as a spin out of the Karmanos Cancer Institute in Detroit.
Delphinus’ transformational SoftVue 3D Whole Breast Tomography System was approved by the U.S. Food & Drug Administration (FDA) in October 2021 as an adjunct to digital mammography in screening asymptomatic women with dense breast tissue. This technology not only redefines the standards for early breast cancer detection, but also enhances patient comfort, and reduces unnecessary callbacks.
Dense breast tissue is common, affecting 40% of women, and making them four to six times more likely to develop breast cancer. Compounding this increased risk, dense breast tissue appears white on mammograms, as do cancerous masses, causing clinicians to miss roughly half of new cancer cases in this population of women. When paired with screening mammography, SoftVue has been shown to identify up to 20% more cancers, while also reducing false positives and decreasing unnecessary call-backs and biopsies.
“Mammography alone is not enough to address the screening needs of dense breast patients,” Delphinus Medical Technologies President/CEO Mark J. Forchette said. “SoftVue provides a solution that enables providers to transform their patients’ clinical experience. Our relationship with Trinity Capital helps us make impactful investments in execution, to help our clinical partners embrace this innovation, and serve the unmet needs of patients with dense breast tissue that SoftVue was designed to address.”
The Trinity funding enables the Delphinus team to continue to scale operations, broadening its impact on the global healthcare community. Delphinus continues to expand its commercial foundation, most recently adding Corewell Health to the roster of clinical sites that are building robust dense breast screening programs to benefit patients. Earlier this year, Delphinus announced the expansion of its list of commercial and research partners with a new installation at The University of Rochester Medical Center.
“We are excited to be a part of Delphinus’ journey as they innovate life-saving medical imaging technology,” said Lauren Cosentino, managing director, life sciences, at Trinity. “We believe in their team and are excited to help accelerate their growth trajectory.”
SoftVue has previously received three FDA 510(k)s, and PMA approval for dense breast screening adjunct to mammography expands the company’s existing platform of approvals to include breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is BI-RADS c or d at the time of screening mammography. The device is not intended to be used as a replacement for screening mammography. SoftVue can be used at the same visit as screening mammography, and the SoftVue images are intended to be interpreted with the mammogram results to enhance screening.
Trinity Capital Inc., an internally managed business development company, provides diversified financial solutions to growth-stage companies with institutional equity investors. Trinity Capital's investment objective is to generate current income and, to a lesser extent, capital appreciation through investments, including term loans and equipment financings and equity-related investments.
Headquartered in Novi, Mich., Delphinus Medical Technologies Inc. has developed SoftVue, featuring the first circular array transducer technology. The patented technology is a 3D whole breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan. Delphinus was founded as a spin out of the Karmanos Cancer Institute in Detroit.