Ultrasound Breast Cancer Imaging Device Created At The Karmanos Cancer Institute One Step Closer To FDA Approval

The interaction of sound waves with cancerous tissue yields a unique signature that can be measured using the SoftVue technology. The SoftVue system collects information not often detected by conventional ultrasound imaging, resulting in a more accurate and complete image of the tissue characteristics.    

The SoftVue exam:

• Takes about one minute per exam
• Produces images for the radiologist in less than 15 minutes
• Does not involve radiation or compression used in mammography – the current gold standard for breast cancer imaging, and 
• Is a fraction of the cost of breast MRI (magnetic resonance imaging)

With SoftVue, the breast is submerged in warm water and an ultrasound transducer ring surrounds the breast without touching it. The SoftVue system transmits and receives ultrasound signals around the entire breast that allow it to capture detailed, three-dimensional images.

The system is able to perform repeated imaging, a necessary tool for biopsy, monitoring and treatment assessment.

SoftVue's detailed images aid the radiologist in making an accurate breast cancer diagnosis. It's believed that SoftVue could help reduce the number of false positives that can occur with mammography and thereby reduce unnecessary biopsies.

Next Steps

Once market clearance is received for the first FDA submission, other SoftVue systems will be produced for other medical centers that will take part in clinical studies needed to secure further FDA approvals for SoftVue. Up to now, SoftVue studies were only for diagnostic purposes, showing the quality and safety of this technology compared to other ultrasound breast cancer imaging devices.

The company plans to carry out clinical trials involving approximately 15,000 - 20,000 subjects to support an FDA Pre-Market Approval Application, which, once approved, will give Delphinus the green light to sell SoftVue for breast cancer screening in the United States. William Greenway, Delphinus' CEO, anticipates that could take until 2015, depending on the number of people participating in the clinical studies at various medical centers, as well as funding to manufacture the systems.

"Once we secure this first FDA clearance, we'll receive signed commitments from other health centers that have expressed interest in SoftVue," said Greenway. "The approximate cost for the SoftVue machine is $400,000, comparable to mammography. We anticipate that we'll need another $15 - $17 million in venture capital to carry out the trials and produce the machines, which will be manufactured in Michigan."

How to Access SoftVue

Mammography is still the gold standard in breast cancer screening; however, for hospitals and medical centers such as the Karmanos Cancer Institute where SoftVue will be available, SoftVue will serve as a follow-up to breast cancer screening upon initial FDA market clearance.

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