Delphinus, which was founded in 2010, began as a research project funded at Karmanos Cancer Institute through Angel money and grants in 1999 in order to develop what's now being called SoftVue technology
Peter Littrup, a radiologist, imaging scientist, physicist and one of inventors of SoftVue, said the idea was to use ultrasound as a means of screening in a new way, taking pictures far differently - more like a CAT scanner would.
"What's unique and different about it is that ultrasound just basically gets reflected signals," he said. "But because we've got sensors on one side of the breast and the other, we actually get new transmission parameters that haven't been available before called sound, speed and attenuation. Where you get an idea of how dense the breast is and how stiff areas of the breast are"
Littrup said density and stiffness are extremely important to cancer screening.
"If you have dense breasts you have more than six times of a risk for breast cancer," he said. "But the conundrum there is, if you have dense breasts, regular technology - mammograms - miss half of of them. So it's like you're at high risk, but I can't see half the cancers."
Littrup is referring to recent studies that have determined that one in two mammograms are not effective in finding cancer for women with dense breasts.SoftVue offers a safe way of imaging, without the use of radiation, and is therefore available to more women in need because there are no limitations, age requirements or frequency requirements like there are in mammography, according to Debra Saunders, Delphinus Vice President of Sales and Marketing.
"The patient lies on the memory foam table with her breast in a warm water bath, and that's all she'll feel - gosh that's nice!" Saunders said. "What's happening then - is there's a ring, an ultrasound ring, we call it a ring transducer - that is on the outside of this bath and it will move from the chest wall down to the nipple. It will be doing ultrasound imaging as it moves from the back of the breast to the front of the breast. The system takes all of that information and reconstructs it. Then look at planes or slices of the breast using ultrasound - it's a very different concept."
SoftVue has not received market clearance from the Food and Drug Administration (FDA) and is not commercially available at this time. However, Saunders said the product is currently under review.
Littrup said there have been clinical trials with more than 600 patients.
"It's not the usual standard trials," he said. "A huge amount of effort has to go into making the pictures really digestible and understandable to people like me - the other hat that I wear of just being a regular radiologist who looks at pictures and makes the diagnosis. So we're actually dealing with some new parameters we've never had before."
Littrup said the new technology is finally ready due in part to - believe it or not - video games.
"In the last two to three years, as an example, if it weren't for video gaming going through the roof and allowing some of the computer chips to be super fast for image processing, there's very little way we could have developed a fast enough product to be clinically relevant," he said. "It's kind of a cool sort of coming together."