DETROIT, Nov. 16 /PRNewswire-USNewswire/ -- After more than 10 years of research and development, the Barbara Ann Karmanos Cancer Institute announced its launch of a new company to build and market a breast cancer screening device invented at Karmanos. 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. The company 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.
"I'm proud to work with a dedicated team of physicians, scientific researchers and other medical experts who are committed to having a world free of cancer," said Ann G. Schwartz, Ph.D., MPH, interim president and chief executive officer, Karmanos Cancer Institute. "Neb Duric, Ph.D., and Peter J. Littrup, M.D., as well as their entire research team, never lost sight of the significance of achieving their goal. They continue to work tirelessly so this incredible imaging technology can go beyond the trial stage to benefit more people and help save lives."
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.
How it Works
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.
For 34-year-old breast cancer survivor Pamela Haddox, RN, of Huron Township, this non-invasive screening technology was much easier on her as a patient diagnosed with breast cancer, and would also be a comfort to others who are uneasy about screening for the disease.
"I found a lump during my routine self-breast exam last year and scheduled an appointment immediately," said Haddox, who works in the medical surgical unit at Detroit Receiving Hospital. "My mom was diagnosed with breast cancer at 43 so I know how important it is to detect cancer in its early stage. I wanted to do everything I could to beat this disease."
Haddox came to the Karmanos Cancer Institute. Her mammography showed a suspicious mass. Just before her biopsy, Haddox was asked if she wanted to take part in a clinical study related to new breast imaging technology created at Karmanos. She agreed, knowing that it could make a difference for others in the future.
"My first experience with this imaging was just before my biopsy. The exam was quick and there was no discomfort whatsoever," expressed Haddox.
The biopsy confirmed that Haddox had Stage II invasive ductal breast cancer.
"I went through several weeks of chemotherapy to shrink the tumor before I could have surgery. As part of the clinical trial, I would go each week to have another ultrasound of my breast with this new technology. Since there was no radiation or compression, it was safe and much easier to monitor how effective the treatment was on shrinking my tumor based on the enhanced images. The tumor mass did shrink, and I was able to have surgery in June 2009."
Haddox, who is still undergoing treatment, added, "From a patient's perspective, there was no discomfort or added anxiety from the process. It only takes a couple of minutes compared to MRIs, which take 45 minutes, or a mammography, which can be painful. And it's safe. I would love for all women to have access to this new technology."
A woman is diagnosed with breast cancer every three minutes in the United States and every 29 seconds globally. The American Cancer Society estimates that more than 40,000 women will die of breast cancer in the United States this year alone. Karmanos believes that the SoftVue technology will significantly help improve breast cancer statistics and ultimately help save lives.
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.
Delphinus seeks to raise $5.5 million in venture capital to finance the company's projected activities for the next 24 - 30 months. For more information on Delphinus visit www.delphinusmt.com or call 313-576-8252.
About the Barbara Ann Karmanos Cancer Institute
Located in mid-town Detroit, Michigan, the Barbara Ann Karmanos Cancer Institute is one of 40 National Cancer Institute-designated comprehensive cancer centers in the United States. Caring for nearly 6,000 new patients annually on a budget of $216 million, conducting more than 700 cancer-specific scientific investigation programs and clinical trials, Karmanos is among the nation's best cancer centers. Through the commitment of 1,000 staff, including nearly 300 physicians and researchers on faculty at the Wayne State University School of Medicine, and supported by thousands of volunteer and financial donors, Karmanos strives to prevent, detect and eradicate all forms of cancer. Its long-term partnership with the WSU School of Medicine enhances the collaboration of critical research and academics related to cancer care. Karmanos is southeastern Michigan's most preferred hospital for cancer care according to annual surveys conducted by the National Research Corporation. For more information call 1-800-KARMANOS or go to www.karmanos.org.
SOURCE Karmanos Cancer Institute
|SOURCE Karmanos Cancer Institute|
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