DETROIT — 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 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 and Neb Duric 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.
Said Gerold Bepler, M.D., president and CEO of the Barbara Ann Karmanos Cancer Institute: “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.
SoftVue uses ultrasound waves, rather than X-rays, to create its images. Karmanos officials say ultrasound waves have the potential to detect early stages of breast cancer, even in women with dense breast tissue, where early stage cancers are 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 a minute, produces images for the radiologist in less than 15 minutes, does not involve the radiation or compression used in mammography, and is a fraction of the cost of breast 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.
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 to 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,” Greenway said. “The approximate cost for the SoftVue machine is $400,000, comparable to mammography. We anticipate that we’ll need another $15 to $17 million in venture capital to carry out the trials and produce the machines, which will be manufactured in Michigan.”
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.
Currently, SoftVue is available at the Karmanos Cancer Institute and Karmanos patients may sign up to be part of the ongoing clinical studies. Once the first FDA clearance is secured, additional SoftVue systems will be produced and placed in other medical centers interested in this technology.
For more information on SoftVue technology contact Delphinus Medical Technologies at (734) 233-3088. For patients interested in participating in SoftVue’s clinical studies for breast cancer screening, call the Karmanos Cancer Institute at 1-800-KARMANOS (1-800-527-6266.)