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Karmanos Cancer Institute announced its launch of a new company and the innovative technology developed as C.U.R.E. (Computerized Ultrasound Risk Evaluation), now referred to as SoftVue, will be marketed under the new spin-off company called Delphinus Medical Technologies, LLC.

Delphinus Medical Technologies has already secured sale commitments for the SoftVue system from several health institutions nationally and internationally.

More than 300 women were involved in the initial clinical studies, which confirmed that SoftVue accurately and safely identifies breast cancer. SoftVue uses multi-parametric ultrasound and sophisticated computer algorithms rather than X-rays. The SoftVue exam takes about one minute, does not involve radiation or compression as the current mammography, and is a fraction of the cost of MRI ( magnetic resonance imaging ). It's believed that it will help reduce the number of false positives that can occur with mammography and thereby reduce unnecessary biopsies.

Delphinus, which is Latin for dolphin, symbolizes the use of underwater sound signals representative of SoftVue. Delphinus' leadership team includes Chief Executive Officer William C. Greenway; Chief Medical Officer Dr. Littrup; and Chief Technical Officer Dr. Duric. Both Drs. Littrup and Duric of Karmanos are key co-inventors of the ultrasound tomography technology (UST). Dr. Littrup designed the ultrasound clinical studies, and Dr. Duric is the project director of UST.

What differentiates the SoftVue system from mammography, the current gold standard for breast cancer screening, is that this unique technology helps to accurately detect many early stages of breast cancer even in women with dense breast tissue, often not picked up by mammography. The SoftVue system is a tomographic ultrasound imaging and risk assessment device that examines women's breasts for the presence of benign and/or malignant masses. The process does not involve radiation or compression.

Instead, the breast is submerged in warm water and an ultrasound ring surrounds the breast and captures detailed, three-dimensional images through the use of sound waves. The system is also able to perform repeated imaging, a necessary tool for monitoring and treatment assessment. Furthermore, through its three-dimensional capabilities, SoftVue can accurately measure breast density, a known risk factor for developing breast cancer. The system provides enhanced fusion imaging incorporating reflection, sound speed and sound attenuation information. The detailed images generated allow the radiologist to make an accurate breast cancer diagnosis. The results are similar to MRI; however the SoftVue system takes only minutes and costs much less.

With the creation of Delphinus comes the creation of jobs. Approximately 50 - 100 highly technical engineering system and software positions will be needed within the next three to five years. Final assembly, testing and quality assurance of the product will be done at the company's facility, which will be located in southeast Michigan. Delphinus plans to use dealer sales organizations in the United States for the distribution of its product, as well as imaging Original Equipment Manufacturers (OEMs) outside of the U.S.

The company will follow-up with the introduction of the product for screening women who are at high risk of breast cancer and eventually serve the entire spectrum of breast imaging needs. Research carried out with the SoftVue product has been conducted under an investigational device exemption. The process to secure approval from the U.S. Food and Drug Administration is underway.

Source: Karmanos Cancer Institute

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