Karmanos Cancer Institute’s SoftVue system under FDA review for market clearance

Published on January 29, 2013 at 1:32 AM · No Comments

SoftVue, the whole breast ultrasound imaging device created by two scientists from the Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, is currently undergoing review by the U.S. Food and Drug Administration (FDA) for market clearance. It's anticipated that this first application clearance could come this spring, with several other FDA submissions to follow over the next couple of years. This promising imaging tool has the potential to aid in detecting breast cancer earlier, especially in women with dense breasts.

Peter Littrup , M.D., and Neb Duric, Ph.D., of the Karmanos Cancer Institute and Wayne State University School of Medicine, and their team have been working to perfect the SoftVue technology for more than a decade. The Karmanos Cancer Institute spun off a company in 2009 called Delphinus Medical Technologies to help secure funding to bring this device closer to commercialization. Since then, Delphinus has grown to 19 employees, many of whom are engineers, and plans are underway to gradually increase the sales staff once the first FDA market clearance is obtained.

"We are pleased to see the progress of SoftVue over the past 12 years, first with the concept followed by the prototype created at Karmanos a few years later," said Gerold Bepler , M.D., Ph.D., president and CEO of the Barbara Ann Karmanos Cancer Institute. "After years of dedication and hard work by co-creators Peter Littrup , M.D., and Neb Duric, Ph.D., along with their team, we are delighted that Karmanos has the first commercial-grade SoftVue system to offer to our patients. Information obtained from this new SoftVue system will continue the next round of clinical research for use in diagnostic breast imaging.

"SoftVue is another example of the exceptional cancer research and innovative technology created right here at the Karmanos Cancer Institute in Detroit, and built in Michigan."   

More than $32 million in funding, including venture capital and other grants, helped turn SoftVue's technology into a commercial product – pending FDA clearance to market. The first round of venture capital funding included Michigan companies Arboretum Ventures, Altarum Institute, Beringea, LLC's InvestMichigan! Growth Capital Fund and North Coast Technology Investors. Other funding, past and present, was received from several private donors along with grants from the National Institutes of Health, the Susan G. Komen Breast Cancer Foundation and the Michigan Economic Development Corp. Currently, the Karmanos Cancer Institute has the only commercial-grade SoftVue system in the world. 

How SoftVue Works

SoftVue uses ultrasound waves, rather than X-rays, which have the potential to aid in detecting early stages of breast cancer, even in women with dense breast tissue often not picked up by mammography.

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.

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